Combination Chemotherapy With or Without Radiation Therapy in Treating Patients With Hodgkin's Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma
Intervention: Doxorubicin; Bleomycin; Vinblastine; Dacarbazine; Vincristine; Mechlorethamine; Etoposide; Prednisone; Cyclophosphamide; Radiotherapy
Intervention description: given IV; given IV; given IV; given IV; given IV; given IV; given IV; taken orally; given IV
Intervention MeSH terms: Prednisone; Cyclophosphamide; Dacarbazine; Mechlorethamine; Doxorubicin; Liposomal doxorubicin; Etoposide; Vincristine; Etoposide phosphate; Bleomycin; Vinblastine; Podophyllotoxin; Imidazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 854.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No
Keywords: stage I adult Hodgkin lymphoma; stage II adult Hodgkin lymphoma; stage III adult Hodgkin lymphoma; stage IV adult Hodgkin lymphoma; adult lymphocyte depletion Hodgkin lymphoma; adult nodular sclerosis Hodgkin lymphoma; adult mixed cellularity Hodgkin lymphoma

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 cancer
      cells. Combining more than one drug with radiation therapy may kill more cancer cells. It is
      not yet known which combination chemotherapy regimen is most effective in treating Hodgkin's
      lymphoma.

      PURPOSE: This randomized phase III trial is studying two different combination chemotherapy
      regimens and comparing how well they work, with or without radiation therapy, in treating
      patients with Hodgkin's lymphoma.
    

Eligibility criteria:

        Inclusion criteria:

          -  Histologically proven previously untreated classical Hodgkin's lymphoma

          -  The following stages are eligible:

               -  Locally extensive: Stage I-IIA/B with massive mediastinal adenopathy

               -  Advanced: Stage III or IV

          -  Measurable or evaluable disease

          -  Age of 16 and over

          -  ECOG Performance status 0-2

          -  Disease-free of prior invasive malignancies for >5 years with the exception of
             curatively-treated basal cell or squamous cell carcinoma of the skin or carcinoma in
             situ of the cervix

          -  White blood cell (WBC) at least 4,000/mm³, (unless documented bone marrow involvement)

          -  Platelet count at least 100,000/mm³ (unless documented bone marrow involvement)

          -  Bilirubin no greater than 5.0 mg/dL

          -  Creatinine no greater than 2.0 mg/dL

          -  Ejection fraction determination recommended if over age 50 and/or have a history of
             cardiac disease

          -  Fertile patients must use effective contraception

          -  Prior corticosteroids allowed

          -  Prior surgery allowed

        Exclusion criteria:

          -  Pregnant or nursing

          -  Prior radiotherapy

          -  Prior chemotherapy

          -  Human immunodeficiency virus (HIV) positive