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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Randomised Phase III Trial to Determine the Role of FDG-PET Imaging in Clinical Stages IA/IIA Hodgkin's Disease

Conditions
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Lymphoma

Intervention / Treatment
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* Radiation: Involved Field Radiotherapy
* Other: No further treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival |  | up to 5 years after randomisation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of FDG-PET scan positivity/negativity after 3 courses of chemotherapy |  | 3 months after treatment start | 
| Survival and cause of death |  | up to 5 years after randomisation | 
| Incidence and type of second cancers |  | up to 5 years after randomisation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage I adult Hodgkin lymphoma, stage II adult Hodgkin lymphoma