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PET Scan in Planning Treatment in Patients Undergoing Combination Chemotherapy For Stage IA or Stage IIA Hodgkin Lymphoma (RAPID)

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: NCT00943423
Recruitment Status : Active, not recruiting
First Posted : July 22, 2009
Last Update Posted : October 23, 2019
Sponsor:
Collaborator:
The Christie NHS Foundation Trust
Information provided by (Responsible Party):
University College, London

Study Description
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Brief Summary:

RATIONALE: A PET scan may help doctors learn how the cancer responded to combination chemotherapy and whether radiation therapy is also required.

PURPOSE: This randomized phase III trial is studying giving a PET scan to see how well it works in deciding whether patients who have received combination chemotherapy for stage IA or stage IIA Hodgkin lymphoma also need radiation therapy.


Condition or disease Intervention/treatment Phase
Lymphoma Radiation: Involved Field Radiotherapy Other: No further treatment Phase 3

Detailed Description:

OBJECTIVES:

  • Determine whether patients with stage IA or IIA Hodgkin lymphoma who have a negative fludeoxyglucose F 18 positron emission tomography (FDG-PET) imaging after 3 courses of chemotherapy comprising doxorubicin hydrochloride, bleomycin sulfate, vinblastine, and dacarbazine (ABVD) require consolidation radiotherapy (to areas of previous involvement) in order to delay or prevent disease progression.

OUTLINE: Patients receive doxorubicin hydrochloride IV, bleomycin sulfate IV, vinblastine IV, and dacarbazine IV (ABVD) on days 1 and 15. Treatment repeats every 28 days for 3 courses. On day 15 of the third course of chemotherapy, patients undergo a CT scan of the neck, thorax, abdomen and pelvis. Patients with nonresponsive disease or progressive disease are removed from the study. Patients who achieve response undergo fludeoxyglucose F 18 positron emission tomography (FDG-PET). Patients with a positive FDG-PET scan receive an additional course of ABVD and undergo involved field radiotherapy. Patients with a negative FDG-PET scan are randomized to 1 of 2 treatment arms.

  • Arm I: Within 6 weeks after completion of course 3 of chemotherapy, patients undergo involved field radiotherapy to disease areas.
  • Arm II: Patients receive no further treatment. After completion of study therapy, patients are followed up every 3 months for 1 year, every 4 months for 1 year, every 6 months for 1 year, and then annually thereafter.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 602 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomised Phase III Trial to Determine the Role of FDG-PET Imaging in Clinical Stages IA/IIA Hodgkin's Disease
Study Start Date : July 2003
Actual Primary Completion Date : July 2014
Estimated Study Completion Date : December 2028

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Arm I
Within 6 weeks after completion of course 3 of chemotherapy, patients undergo involved field radiotherapy to disease areas.
 Radiation: Involved Field Radiotherapy
IFRT 30Gy delivered in daily fractions of 1.8 - 2.0Gy
Experimental: Arm II
Patients receive no further treatment.
 Other: No further treatment


Outcome Measures
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Primary Outcome Measures :
  1. Progression-free survival [ Time Frame: up to 5 years after randomisation ]

Secondary Outcome Measures :
  1. Incidence of FDG-PET scan positivity/negativity after 3 courses of chemotherapy [ Time Frame: 3 months after treatment start ]
  2. Survival and cause of death [ Time Frame: up to 5 years after randomisation ]
  3. Incidence and type of second cancers [ Time Frame: up to 5 years after randomisation ]

Eligibility Criteria
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Ages Eligible for Study:   16 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed Hodgkin Lymphoma

    • Stage IA or IIA disease

      • No stage IA Hodgkin lymphoma with no clinical or CT evidence of disease after diagnostic biopsy

    • Above the diaphragm with no mediastinal bulk, defined as maximum transverse diameter of mediastinal mass

      • Internal thoracic diameter at level of D5/6 interspace > 0.33
    • Bulky disease at other sites, defined as nodal mass with transverse diameter ≥ 10 cm allowed

PATIENT CHARACTERISTICS:

  • Not pregnant or nursing
  • Fertile patients must use effective contraception during and for ≥ 6 months
  • No prior malignancy except appropriately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix
  • No severe underlying illness considered to make the trial therapy hazardous (i.e., severe heart disease or lung fibrosis)
  • Willing to travel to the nearest PET scan center
  • Able to comply with protocol follow-up arrangements

PRIOR CONCURRENT THERAPY:

  • No prior treatment for Hodgkin lymphoma
  • No contraindications to chemotherapy or radiotherapy
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00943423


Locations
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United Kingdom
Christie Hospital
Manchester, England, United Kingdom, M20 4BX
Sponsors and Collaborators
University College, London
The Christie NHS Foundation Trust
Investigators
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Principal Investigator: John Radford, MD The Christie NHS Foundation Trust
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT00943423    
Other Study ID Numbers: 03_DOG05_07
CHNT-RAPID
ISRCTN99811594
EU-20931
First Posted: July 22, 2009    Key Record Dates
Last Update Posted: October 23, 2019
Last Verified: October 2019
Keywords provided by University College, London:
stage I adult Hodgkin lymphoma
stage II adult Hodgkin lymphoma
Additional relevant MeSH terms:
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Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
 Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases