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Combination Chemotherapy Plus Low-Dose Radiation Therapy in Treating Patients With Stage I or Stage IIA Hodgkin's Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00026208
Recruitment Status : Completed
First Posted : January 27, 2003
Results First Posted : May 15, 2018
Last Update Posted : July 24, 2018
Sponsor:
Information provided by (Responsible Party):
Ranjana Advani, Stanford University

Tracking Information
First Submitted Date  ICMJE November 9, 2001
First Posted Date  ICMJE January 27, 2003
Results First Submitted Date  ICMJE March 16, 2018
Results First Posted Date  ICMJE May 15, 2018
Last Update Posted Date July 24, 2018
Study Start Date  ICMJE June 2001
Actual Primary Completion Date April 26, 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 16, 2018)
Progression-free Survival (PFS) [ Time Frame: up to 3 years ]
Progression-free survival was assessed for 3 years from the completion of treatment. Progression-free survival was considered to mean the proportion of patients (percentage) still alive without disease recurrence or progression.
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 22, 2018)
  • Frequency of Complete Response [ Time Frame: 5 weeks ]
    The frequency of complete response (CR) is reported as the number (proportion) of subjects in complete response, as assessed during weeks 4 to 5 of chemotherapy. Per protocol, CR is defined as "complete regression of all palpable and radiographic demonstrable disease" by computed tomography (CT) scan or positron emission tomography-CT (PET-CT).
  • Early Treatment-related Toxicity [ Time Frame: Within 30 days of treatment ]
    Early treatment-related toxicity was assessed as the number of treatment-related, non-serious adverse events that occurred during treatment or within 30 days of the completion of treatment.
  • Late Treatment-related Toxicity [ Time Frame: 16 years ]
    Late treatment-related toxicity was assessed as the overall number of late-appearing toxicities (ie, related adverse events, after treatment completion) including but not limited to diagnosis of a 2nd cancer; hypothyroidism; infertility; pulmonary toxicity; or cardiac toxicity, at up to 16 years from date of diagnosis.
  • Second Hodgkin's Disease Progression [ Time Frame: 16 years ]
    Second Hodgkin's disease progression is reported as the number of participants experiencing 2 instances of progression of the underlying Hodgkin's disease, assessed at up to 16 years from date of diagnosis.
  • Overall Survival (OS) [ Time Frame: 16 years ]
    Overall survival was assessed at up to 16 years from date of diagnosis, and reported as the median years of survival with standard deviation.
  • Survival at 5 and 10 Years [ Time Frame: 5 and 10 years ]
    Survival at 5 and 10 years is expressed at the percentage of subjects known to remain alive at those timepoints.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Combination Chemotherapy Plus Low-Dose Radiation Therapy in Treating Patients With Stage I or Stage IIA Hodgkin's Lymphoma
Official Title  ICMJE Risk-Adapted Stanford V-C With Radiotherapy for Clinical Stage I and IIA Favorable Hodgkin's Disease: The G5 Study
Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells.

PURPOSE: This phase 2 trial is studying how well giving combination chemotherapy together with low-dose radiation therapy works in treating patients with stage I or stage IIA Hodgkin's lymphoma.

Detailed Description

OBJECTIVES:

  • Evaluate the freedom from progression in patients with stage I or IIA Hodgkin's lymphoma with a favorable prognosis treated with "Stanford V-C" chemotherapy comprising cyclophosphamide, doxorubicin, vinblastine, prednisone, vincristine, bleomycin, and etoposide with low-dose radiotherapy (RT).
  • Minimize the early and late effects of treatment in these patients by avoiding staging laparotomy and its consequences, limiting cumulative doses of chemotherapy, and reducing the dose of RT to moderately bulky sites of disease.
  • Assess early and late treatment-related toxicity, freedom from second disease progression, and overall survival at 5 and 10 years in patients treated with this regimen.

Participants receive Stanford V-C chemotherapy comprising cyclophosphamide IV over 30 to 60 minutes weekly on weeks 1 and 5; doxorubicin IV and vinblastine IV over 5 minutes once weekly on weeks 1, 3, 5, and 7; oral prednisone every other day on weeks 1 to 8; vincristine IV, and bleomycin IV over 5 minutes once weekly on weeks 2, 4, 6, and 8; and etoposide IV over 60 minutes on days 1 and 2 of weeks 3 and 7. Prior to protocol amendment, participants were assigned to treatment on the basis of tumor size (< 5 cm vs 5 to 10 cm), with only the participants with larger tumors receiving RT. Beginning 2 to 3 weeks after completion of chemotherapy, participants in the +RT group will receive low-dose radiotherapy 5 days a week for approximately 3 weeks. Subsequent to amendment, all participants received RT.

Participants are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Patients with tumors 5 to 10 cm were to be assigned to concurrent radiotherapy, and participants with tumors less than 5 cm were initially planned to not receive radiotherapy.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Lymphoma, Hodgkin Disease
  • Lymphoma
  • Hodgkin Disease
  • Lymphoma: Hodgkin
Intervention  ICMJE
  • Drug: Vincristine
    1.4 mg/m² intravenously (IV) on week 2, 4, 6, 8
    Other Names:
    • Vinblastine
    • Leurocristine sulfate
    • Oncovin
    • Vincasar
    • LCR
    • VCR
    • Vincristin
    • Vincristina
    • Vincristinum
    • 22-Oxovincaleukoblastin
    • 22-Oxovincaleukoblastine
  • Drug: Cyclophosphamide
    650 mg/m², on week 1 and 5
    Other Names:
    • Cytoxan
    • Neosar
    • Cyclophosphamidum
    • Cyclophosphamid
    • Ciclofosfamida
    • Cytophosphane
    • Ledoxina
    • Bis(2-chloroethyl)phosphoramide cyclic propanolamide ester
    • 2-[Bis(2-chloroethylamino)]-tetrahydro-2H-1,3,2-oxazaphosphorine-2-oxide
    • N,N-Bis(2-chloroethyl)tetrahydro-2H-1,3,2-oxazaphosphorin-2-amine 2-oxide
  • Drug: Doxorubicin
    25 mg/m², on week 1, 3, 5, 7
    Other Names:
    • Adriamycin
    • Doxorubicinum
    • Doxorubicine
    • Rubex
    • Hydroxydaunomycin HCl
    • Hydroxydoxorubicin HCl
    • Hydroxydaunorubicin
    • 14-hydroxydaunomycin
    • 14-hydroxydaunorubicine
    • (1S,3S)-3-Glycoloyl-3,5,12-trihydroxy-10-methoxy-6,11-dioxo-1,2,3,4,6,11-hexahydrotetracen-1-yl 3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranoside
    • (8S-cis)-10-((3-amino-2,3,6-Trideoxy-alpha-L-lyxo-hexopyranosyl)oxy)-7,8,9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-5,12-naphthacenedione
  • Drug: Prednisone
    40 mg/m², oral, every other day. Taper-reduction 10 mg/m² every other day during last 2 weeks of chemotherapy
    Other Names:
    • Dehydrocortisone
    • Deltasone
    • Liquid Pred
    • Meticorten
    • Orasone
    • Prednicot
    • predniSONE Intensol
    • Rayos
    • Sterapred
    • Prednisona
    • Prednisonum
    • 1,2-Dehydrocortisone
    • 1,4-Pregnadiene-17alpha,21-diol-3,11,20-trione
    • 17,21-Dihydroxypregna-1,4-diene-3,11,20-trione
  • Drug: Bleomycin
    5 u/m² intravenously (IV) on week 2, 4, 6, 8
    Other Names:
    • Bleomycin A2
    • Bleomycine
    • Bleocin
    • Bleomicin
    • Bleomicina
    • Bleomycinum
    • BLM
  • Drug: Etoposide
    60 mg/m² x 2 intravenously (IV) on week 3, 7 (d 15, 16, 43, 44)
    Other Names:
    • Toposar
    • Etopophos
    • Vepesid
    • VP-16
    • Etoposido
    • Etoposidum
    • trans-Etoposide
    • 4-demethylepipodophyllotoxin β-D-ethylideneglucoside
    • 4'-Demethylepipodophyllotoxin 9-(4,6-O-(R)-ethylidene-beta-D-glucopyranoside)
    • 9-((4,6-O-Ethylidine-beta-D-glucopyranosyl)oxy)-5,8,8a,9-tetrahydro-5-(4-hydroxy-3,4-dimethyloxyphenyl)furo(3',4'':6,7)naptho-(2,3-d)-1,3-dioxol-6(5aH)-one
  • Radiation: Low-dose radiotherapy (RT)
    20 Grey (Gy) modified involved field radiotherapy administered as consolidative irradiation will beginning between 2 and 12 weeks after the completion of Stanford V-C chemotherapy regimen.
Study Arms  ICMJE
  • Experimental: Stanford V-C + Low-dose Radiotherapy

    "Sanford V-C" = Vinblastine, cyclophosphamide, doxorubicin, prednisone, bleomycin, + etoposide.

    Radiotherapy = 20 Gy modified involved field radiotherapy

    Interventions:
    • Drug: Vincristine
    • Drug: Cyclophosphamide
    • Drug: Doxorubicin
    • Drug: Prednisone
    • Drug: Bleomycin
    • Drug: Etoposide
    • Radiation: Low-dose radiotherapy (RT)
  • Experimental: Stanford V-C only
    "Sanford V-C" = Vinblastine, cyclophosphamide, doxorubicin, prednisone, bleomycin, + etoposide.
    Interventions:
    • Drug: Vincristine
    • Drug: Cyclophosphamide
    • Drug: Doxorubicin
    • Drug: Prednisone
    • Drug: Bleomycin
    • Drug: Etoposide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 2, 2017)
76
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE February 13, 2017
Actual Primary Completion Date April 26, 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

INCLUSION CRITERIA:

  • Diagnosis of previously untreated stage I or IIA Hodgkin's lymphoma, eligible subtypes

    • Nodular sclerosis
    • Mixed cellularity
    • Classical, not otherwise specified
  • Age ≥ 18 years and ≤ 70 years
  • Granulocytes ≥ 2 x 10e6/µL
  • Platelets ≥ 150 x 10e6/µL
  • Bilirubin ≤ 2.5 mg/dL
  • Serum creatinine ≤ 2 mg/dL
  • Patients > 50 years or those with a history of cardiac disease should have an ejection fraction ≥ 50%
  • All scans, X-rays, laboratory tests must be performed within 6 weeks of enrollment
  • Pathologic material reviewed at Stanford University
  • Evaluation by Stanford Medical Oncology and Radiation Oncology with review at the Hodgkin's Disease Staging Conference
  • Written informed consent

EXCLUSION CRITERIA:

  • Lymphocytic predominance Hodgkin's disease
  • Prior treatment for Hodgkin's disease
  • Mediastinal mass equal to or greater than one-third the maximum intrathoracic diameter on a standing posteroanterior chest x-ray
  • Any lymph node mass > 10 cm in greatest trans-axial diameter
  • Two or more extranodal sites of disease
  • Constitutional (B) symptoms present at diagnosis
  • Prior or concurrent malignancies within 5 years (EXCEPTION: basal cell carcinoma of the skin)
  • Any medical contraindication to the planned treatment, including:

    • Pregnant
    • Positive antibody test for the human immunodeficiency virus (HIV)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00026208
Other Study ID Numbers  ICMJE IRB-13081
LYMHD0002 ( Other Identifier: OnCore )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Ranjana Advani, Stanford University
Study Sponsor  ICMJE Stanford University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ranjana H Advani, MD Stanford University
PRS Account Stanford University
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP