Combination Chemotherapy Plus Low-Dose Radiation Therapy in Treating Patients With Stage I or Stage IIA Hodgkin's Lymphoma
Condition: Lymphoma, Hodgkin Disease; Lymphoma; Hodgkin Disease; Lymphoma: Hodgkin
MeSH terms: Lymphoma; Hodgkin Disease
Intervention: Vincristine; Cyclophosphamide; Doxorubicin; Prednisone; Bleomycin; Etoposide; Low-dose radiotherapy (RT)
Intervention description: 1.4 mg/m² intravenously (IV) on week 2, 4, 6, 8; 650 mg/m², on week 1 and 5; 25 mg/m², on week 1, 3, 5, 7; 40 mg/m², oral, every other day. Taper-reduction 10 mg/m² every other day during last 2 weeks of chemotherapy; 5 u/m² intravenously (IV) on week 2, 4, 6, 8; 60 mg/m² x 2 intravenously (IV) on week 3, 7 (d 15, 16, 43, 44); 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.
Intervention MeSH terms: Prednisone; Cyclophosphamide; Doxorubicin; Liposomal doxorubicin; Etoposide; Etoposide phosphate; Vincristine; Bleomycin; Vinblastine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
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)
Enrollment: 76.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        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)