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Chemotherapy With Low-Dose Radiation for Pediatric Hodgkin Lymphoma

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:
NCT00352027
First received: July 13, 2006
Last updated: September 19, 2016
Last verified: September 2016
  Purpose
The main purpose of this protocol is to estimate the percentage of patients with intermediate risk Hodgkin lymphoma who will survive free of disease (Event-free survival) for three years after treatment with multi-agent chemotherapy (Stanford V) and low-dose, tailored-field radiation therapy. The hypothesis being studied is that this treatment will result in more than 80% of patients being alive and free of disease three years after starting treatment.

Condition Intervention Phase
Hodgkin's Lymphoma
Drug: Adriamycin®
Drug: Vinblastine
Drug: Nitrogen Mustard
Drug: Cyclophosphamide
Drug: Vincristine
Drug: Bleomycin
Drug: Etoposide
Drug: Prednisone
Biological: G-CSF
Procedure: Radiotherapy
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Stanford V Chemotherapy With Low-Dose Tailored-Field Radiation Therapy for Intermediate Risk Pediatric Hodgkin Lymphoma

Resource links provided by NLM:


Further study details as provided by St. Jude Children's Research Hospital:

Primary Outcome Measures:
  • 3-year Event-Free Survival Probability [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    The survival probability for the time interval from treatment start to the time of the first failure (disease recurrence, second malignancy or death) within a 3-year time frame.


Secondary Outcome Measures:
  • Disease Failure Rate Within Radiation Fields [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Defined as disease that recurs in the initially involved nodal region within the field of irradiation. The disease failure rate within the radiation fields will be estimated with a 95% confidence interval using appropriate methods (e.g., estimate cumulative incidence in the presence of competing risks).

  • Local and Distant Failure for Children Treated With Tailored-field Radiation [ Time Frame: from first enrollment date up to 3 years follow-up ] [ Designated as safety issue: No ]
    The cumulative incidence of local and distant failure will be estimated. Effect of competing risks will be taken into account. Local failure is defined as in-field, and distant failure is defined as out-of-field.

  • Prognostic Factors for Treatment Failure: Age [ Time Frame: 5.5 (years) median follow-up with minimum 0.3 to maximum 9.4 years follow-up ] [ Designated as safety issue: No ]
    Age was examined for the association with event-free survival (EFS) which was defined as the interval between date on study and date of relapse/disease progression, second malignant tumor, death, or last contact, whichever came first. Given only 11 events, the investigators used univariate Cox model with Score test to compute the p value for the statistical significance.

  • Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy [ Time Frame: 1, 2, 5, and 10 years post therapy ] [ Designated as safety issue: No ]
  • Patient Quality of Life (QoL), PedsQL v.4.0: Total Score [ Time Frame: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy ] [ Designated as safety issue: No ]

    Patient QOL will be measured at multiple time points to assess the patient's functioning.

    Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.


  • Patient Quality of Life (QoL), PedsQl v.4.0: Physical Functioning [ Time Frame: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy ] [ Designated as safety issue: No ]

    Patient QOL will be measured at multiple time points to assess the patient's functioning.

    Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.


  • Patient Quality of Life (QoL), PedsQL v.4.0: Psychosocial Health [ Time Frame: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy ] [ Designated as safety issue: No ]

    Patient QOL will be measured at multiple time points to assess the patient's functioning.

    Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.


  • Patient Quality of Life (QoL), PedsQL v.4.0: Emotional Functioning [ Time Frame: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy ] [ Designated as safety issue: No ]

    Patient QOL will be measured at multiple time points to assess the patient's functioning.

    Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.


  • Patient Quality of Life (QoL), PedsQL v.4.0:Social Functioning [ Time Frame: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy ] [ Designated as safety issue: No ]

    Patient QOL will be measured at multiple time points to assess the patient's functioning.

    Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.


  • Patient Quality of Life (QoL), PedsQL v.4.0: School Functioning [ Time Frame: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy ] [ Designated as safety issue: No ]

    Patient QOL will be measured at multiple time points to assess the patient's functioning.

    Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.


  • Patient Quality of Life (QoL), PedsQL v.3.0: Total Score [ Time Frame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy ] [ Designated as safety issue: No ]

    Patient QOL will be measured at multiple time points to assess the patient's functioning.

    Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.


  • Patient Quality of Life (QoL), PedsQL v.3.0: Pain and Hurt [ Time Frame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy ] [ Designated as safety issue: No ]

    Patient QOL will be measured at multiple time points to assess the patient's functioning.

    Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.


  • Patient Quality of Life (QoL), PedsQL v.3.0: Nausea [ Time Frame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy ] [ Designated as safety issue: No ]

    Patient QOL will be measured at multiple time points to assess the patient's functioning.

    Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.


  • Patient Quality of Life (QoL), PedsQL v.3.0: Procedural Anxiety [ Time Frame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy ] [ Designated as safety issue: No ]

    Patient QOL will be measured at multiple time points to assess the patient's functioning.

    Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.


  • Patient Quality of Life (QoL), PedsQL v.3.0: Treatment Anxiety [ Time Frame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy ] [ Designated as safety issue: No ]

    Patient QOL will be measured at multiple time points to assess the patient's functioning.

    Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.


  • Patient Quality of Life (QoL), PedsQL v.3.0: Worry [ Time Frame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy ] [ Designated as safety issue: No ]

    Patient QOL will be measured at multiple time points to assess the patient's functioning.

    Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.


  • Patient Quality of Life (QoL), PedsQL v.3.0: Cognitive Problems [ Time Frame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy ] [ Designated as safety issue: No ]

    Patient QOL will be measured at multiple time points to assess the patient's functioning.

    Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.


  • Patient Quality of Life (QoL), PedsQL v.3.0: Perceived Physical Appearance [ Time Frame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy ] [ Designated as safety issue: No ]

    Patient QOL will be measured at multiple time points to assess the patient's functioning.

    Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.


  • Patient Quality of Life (QoL), PedsQL v.3.0: Communication [ Time Frame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy ] [ Designated as safety issue: No ]

    Patient QOL will be measured at multiple time points to assess the patient's functioning.

    Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.


  • Patient Quality of Life (QoL), Symptom Distress Scale [ Time Frame: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy ] [ Designated as safety issue: No ]

    The patient's degree of discomfort from specific treatment-related symptoms across multiple time points.

    Instrument interpretation: SDS, higher scores indicate higher overall symptom distress with a range of 10-50.


  • Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Total Score [ Time Frame: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy ] [ Designated as safety issue: No ]
    Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.

  • Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Physical Functioning [ Time Frame: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy ] [ Designated as safety issue: No ]
    Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.

  • Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Psychosocial Health [ Time Frame: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy ] [ Designated as safety issue: No ]
    Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.

  • Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Emotional Functioning [ Time Frame: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy ] [ Designated as safety issue: No ]
    Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.

  • Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Social Functioning [ Time Frame: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy ] [ Designated as safety issue: No ]
    Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.

  • Parent Proxy Quality of Life (QoL), PedsQL v.4.0: School Functioning [ Time Frame: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy ] [ Designated as safety issue: No ]
    Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.

  • Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Total Score [ Time Frame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy ] [ Designated as safety issue: No ]
    Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.

  • Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Pain and Hurt [ Time Frame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy ] [ Designated as safety issue: No ]
    Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.

  • Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Nausea [ Time Frame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy ] [ Designated as safety issue: No ]
    Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.

  • Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Procedural Anxiety [ Time Frame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy ] [ Designated as safety issue: No ]
    Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.

  • Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Treatment Anxiety [ Time Frame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy ] [ Designated as safety issue: No ]
    Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.

  • Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Worry [ Time Frame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy ] [ Designated as safety issue: No ]
    Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.

  • Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Cognitive Problems [ Time Frame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy ] [ Designated as safety issue: No ]
    Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.

  • Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Perceived Physical Appearance [ Time Frame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy ] [ Designated as safety issue: No ]
    Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.

  • Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Communication [ Time Frame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy ] [ Designated as safety issue: No ]
    Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.

  • Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Total Score [ Time Frame: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy ] [ Designated as safety issue: No ]

    Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.

    Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.


  • Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Physical Functioning [ Time Frame: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy ] [ Designated as safety issue: No ]

    Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.

    Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.


  • Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Psychosocial Health [ Time Frame: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy ] [ Designated as safety issue: No ]

    Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.

    Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.


  • Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Emotional Functioning [ Time Frame: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy ] [ Designated as safety issue: No ]

    Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.

    Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.


  • Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Social Functioning [ Time Frame: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy ] [ Designated as safety issue: No ]

    Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.

    Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.


  • Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: School Functioning [ Time Frame: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy ] [ Designated as safety issue: No ]

    Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.

    Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.


  • Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Total Score [ Time Frame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy ] [ Designated as safety issue: No ]

    Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.

    Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.


  • Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Pain and Hurt [ Time Frame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy ] [ Designated as safety issue: No ]

    Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.

    Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.


  • Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Nausea [ Time Frame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy ] [ Designated as safety issue: No ]

    Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.

    Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.


  • Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Procedural Anxiety [ Time Frame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy ] [ Designated as safety issue: No ]

    Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.

    Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.


  • Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Treatment Anxiety [ Time Frame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy ] [ Designated as safety issue: No ]

    Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.

    Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.


  • Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Worry [ Time Frame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy ] [ Designated as safety issue: No ]

    Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.

    Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.


  • Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Cognitive Problems [ Time Frame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy ] [ Designated as safety issue: No ]

    Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.

    Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.


  • Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Perceived Physical Appearance [ Time Frame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy ] [ Designated as safety issue: No ]

    Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.

    Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.


  • Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Communication [ Time Frame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy ] [ Designated as safety issue: No ]

    Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.

    Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.


  • Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Total Score [ Time Frame: 6 months after the completion of therapy ] [ Designated as safety issue: No ]

    Relationship between quality of life and symptom distress instruments aggregated across multiple time points [At diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.

    Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50.


  • Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Physical Functioning [ Time Frame: 6 months after the completion of therapy ] [ Designated as safety issue: No ]

    Relationship between quality of life and symptom distress instruments aggregated across multiple time points [At diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.

    Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50.


  • Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Psychosocial Health [ Time Frame: 6 months after the completion of therapy ] [ Designated as safety issue: No ]

    Relationship between quality of life and symptom distress instruments aggregated across multiple time points [At diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.

    Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50.


  • Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Emotional Functioning [ Time Frame: 6 months after the completion of therapy ] [ Designated as safety issue: No ]

    Relationship between quality of life and symptom distress instruments aggregated across multiple time points [At diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.

    Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50.


  • Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Social Functioning [ Time Frame: 6 months after the completion of therapy ] [ Designated as safety issue: No ]

    Relationship between quality of life and symptom distress instruments aggregated across multiple time points [At diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.

    Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50.


  • Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: School Functioning [ Time Frame: 6 months after the completion of therapy ] [ Designated as safety issue: No ]

    Relationship between quality of life and symptom distress instruments aggregated across multiple time points [At diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.

    Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50.


  • Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Total Score [ Time Frame: 6 months after the completion of therapy ] [ Designated as safety issue: No ]

    Relationship between quality of life and symptom distress across multiple time points [completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.

    Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50.


  • Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Pain and Hurt [ Time Frame: 6 months after the completion of therapy ] [ Designated as safety issue: No ]

    Relationship between quality of life and symptom distress across multiple time points [completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.

    Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50.


  • Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Nausea [ Time Frame: 6 months after the completion of therapy ] [ Designated as safety issue: No ]

    Relationship between quality of life and symptom distress across multiple time points [completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.

    Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50.


  • Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Procedural Anxiety [ Time Frame: 6 months after the completion of therapy ] [ Designated as safety issue: No ]

    Relationship between quality of life and symptom distress across multiple time points [completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.

    Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50.


  • Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Treatment Anxiety [ Time Frame: 6 months after the completion of therapy ] [ Designated as safety issue: No ]

    Relationship between quality of life and symptom distress across multiple time points [completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.

    Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50.


  • Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Worry [ Time Frame: 6 months after the completion of therapy ] [ Designated as safety issue: No ]

    Relationship between quality of life and symptom distress across multiple time points [completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.

    Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50.


  • Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Cognitive Problems [ Time Frame: 6 months after the completion of therapy ] [ Designated as safety issue: No ]

    Relationship between quality of life and symptom distress across multiple time points [completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.

    Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50.


  • Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Perceived Physical Appearance [ Time Frame: 6 months after the completion of therapy ] [ Designated as safety issue: No ]

    Relationship between quality of life and symptom distress across multiple time points [completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.

    Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50.


  • Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Communication [ Time Frame: 6 months after the completion of therapy ] [ Designated as safety issue: No ]

    Relationship between quality of life and symptom distress across multiple time points [completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.

    Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50.


  • 3-year Event-free Survival (EFS) Probability [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Comparison of thee-year EFS probability along with the whole EFS distributions of intermediate risk patients treated with Stanford V chemotherapy low dose tailored-field radiation to those patients on HOD99.

  • 3-year Overall Survival (OS) Probability [ Time Frame: 3-years ] [ Designated as safety issue: No ]
    Comparison of the 3-year OS probability along with the whole OS distributions of intermediate risk patients treated with Stanford V chemotherapy low dose tailored-field radiation to those patients on HOD99.

  • 3-year Local Failure-free Survival Probability [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Comparison of the 3-year local failure-free survival probability along with the whole local failure-free survival distributions of intermediate risk patients treated with Stanford V chemotherapy low dose tailored-field radiation to those patients on HOD99.

  • Toxicities With Grade >1 [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    Comparison of the toxicities of intermediate risk patients treated with Stanford V chemotherapy low dose tailored-field radiation (current HOD05 protocol) to those patients on HOD99 (NCT00145600). Grading of toxicities for HOD05 and HOD99 used the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.

  • Prognostic Factors for Treatment Failure: Gender [ Time Frame: 3 years follow-up ] [ Designated as safety issue: No ]
    Event-free survival (EFS) was calculated for the 80 eligible patients. EFS was defined as the interval between on study to relapse, second malignant tumor, or last contact (all alive) whichever came first. For those who had multiple relapses, the first one was counted. Given only 11 events, we examined individually age, gender, histology and stage for its association with EFS using Cox model. P values from Score test were computed for the statistical significance.

  • Prognostic Factors for Treatment Failure: Histology [ Time Frame: 3 years follow-up ] [ Designated as safety issue: No ]
    Event-free survival (EFS) was calculated for the 80 eligible patients. EFS was defined as the interval between on study to relapse, second malignant tumor, or last contact (all alive) whichever came first. For those who had multiple relapses, the first one was counted. Given only 11 events, we examined individually age, gender, histology and stage for its association with EFS using Cox model. P values from Score test were computed for the statistical significance.

  • Prognostic Factors for Treatment Failure: Stage [ Time Frame: 5.5 (years) median follow-up with minimum 0.3 to maximum 9.4 years follow-up ] [ Designated as safety issue: No ]
    Ann Arbor staging classification was used to stage all patients. Stage was examined (I/II versus III) for the association with event-free survival (EFS), defined as the interval between date on study and of relapse/disease progression, second malignancy, death, or last contact, whichever came first. Given only 11 events, the investigators used univariate Cox model with Score test to compute the p value for the statistical significance. Stage <III showed a better outcome but was not statistically significant.


Enrollment: 81
Study Start Date: July 2006
Estimated Study Completion Date: November 2022
Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: All Participants
Participants receive 12 weeks of Stanford V chemotherapy which includes Adriamycin®, Vinblastine, Nitrogen Mustard (or Cyclophosphamide), Vincristine, Bleomycin, Etoposide, Prednisone, and G-CSF. After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy.
Drug: Adriamycin®
Given IV on Day 1 of weeks 1, 3, 5, 7, 9 and 11.
Other Name: Doxorubicin
Drug: Vinblastine
Given IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11.
Other Name: Velban®
Drug: Nitrogen Mustard
Given IV, Day 1 of weeks 1, 5 and 9. Cyclophosphamide may be substituted if nitrogen mustard is unavailable.
Other Names:
  • Mustargen®
  • Mechlorethamine Hydrochloride
Drug: Cyclophosphamide
May be substituted if nitrogen mustard is unavailable. Given on Day 1 of weeks 1, 5 and 9.
Other Name: Nitrogen Mustard Derivative
Drug: Vincristine
Given IV on Day 1 of weeks 2, 4, 6, 8, 10 and 12.
Other Name: Velban®
Drug: Bleomycin
Given IV on Day 1 of weeks 2, 4, 6, 8, 10 and 12.
Other Name: Blenoxane®
Drug: Etoposide
Given IV on Days 1 and 2 of weeks 1-10.
Other Names:
  • VP-16
  • Vepesid®
Drug: Prednisone
Given PO every other day of weeks 1-12.
Other Name: Synthetic congener of hydrocortisone
Biological: G-CSF
Given subcutaneously days 3-13, 16-26, 29-39, 42-52, 55-65, and 68-78 (as clinically indicated).
Other Names:
  • Filgrastim
  • Neupogen®
Procedure: Radiotherapy
Participants receive radiotherapy after completion of 12 weeks of Stanford V chemotherapy.
Other Name: Radiation therapy

Detailed Description:

Treatment Plan Description:

Adriamycin 25 mg/m2 IV Day 1 of weeks 1, 3, 5, 7, 9, 11

Vinblastine 6 mg/m2 IV Day 1 of weeks 1, 3, 5, 7, 9, 11

Nitrogen Mustard 6mg/m2 IV on Day 1 of weeks 1, 5, and 9

Cyclophosphamide 650 mg/m2 IV Day 1 of weeks 1, 5, 9(when Nitrogen Mustard was not available due to national shortage)

Vincristine 1.4 mg/m2 IV Day 1 of weeks 2, 4, 6, 8, 10, 12

Bleomycin 5 units/m2 IV Day 1 of weeks 2, 4, 6, 8, 10, 12

Etoposide 60 mg/m2 IV Days 1,2 of weeks 3, 7, 11

Prednisone* 40 mg/m2/day divided in 3 doses PO Every other day of weeks 1-12

G-CSF (only as needed in case of severe myelo-suppression requiring treatment delay) 5 mcg/kg SC Days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated)

* Prednisone taper is foreseen for the last 2 weeks of therapy. Patients will be treated with 12 weeks of Stanford V chemotherapy in the schedule outlined above. Patients will then receive radiation therapy after completion of 12 weeks of chemotherapy. The radiation dose to individual nodal sites will be based on response after 8 weeks of chemotherapy: 15 Gy for areas achieving a complete response and 25.5 Gy achieving less than a complete response, or patients with bulky mediastinal mass.

  Eligibility

Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient is less than or equal to 21 years of age
  • Patient has a confirmed diagnosis of previously untreated Hodgkin lymphoma
  • Has Ann Arbor stage IB, IIIA, or IA/IIA with extranodal extension, multiple nodal involvement (3 or more sites), or bulky mediastinal adenopathy.

Exclusion Criteria:

  • Patients with favorable risk features
  • Patients with unfavorable risk features
  • Patients who have received prior therapy for Hodgkin lymphoma.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00352027

Locations
United States, California
Stanford University Medical Center
Palo Alto, California, United States, 94304
Rady Children's Hospital San Diego
San Diego, California, United States, 92123
United States, Maine
Maine Children's Medical Center
Portland, Maine, United States, 04102-3175
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, Tennessee
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Sponsors and Collaborators
St. Jude Children's Research Hospital
Investigators
Principal Investigator: Monika Metzger, M.D. St. Jude Children's Research Hospital
  More Information

Additional Information:
Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT00352027     History of Changes
Other Study ID Numbers: HOD05 
Study First Received: July 13, 2006
Results First Received: April 27, 2016
Last Updated: September 19, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by St. Jude Children's Research Hospital:
Hodgkin's Disease

Additional relevant MeSH terms:
Mechlorethamine
Nitrogen Mustard Compounds
Lymphoma
Hodgkin Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cyclophosphamide
Etoposide phosphate
Liposomal doxorubicin
Prednisone
Vincristine
Etoposide
Doxorubicin
Vinblastine
Bleomycin
Hydrocortisone
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on December 09, 2016