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Combination Chemotherapy Plus Low-Dose Radiation Therapy in Treating Patients With Stage I or Stage IIA Hodgkin's Lymphoma
Not Recruiting
Trial ID: NCT00026208
Purpose
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.
Official Title
Risk-Adapted Stanford V-C With Radiotherapy for Clinical Stage I and IIA Favorable Hodgkin's Disease: The G5 Study
Stanford Investigator(s)
Ranjana Advani
Saul A. Rosenberg, MD, Professor of Lymphoma
Richard Hoppe
Henry S. Kaplan-Harry Lebeson Professor of Cancer Biology
Eligibility
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)
Intervention(s):
drug: cyclophosphamide
drug: prednisone
drug: bleomycin
drug: vincristine
drug: Doxorubicin
drug: Etoposide
radiation: Low-dose radiotherapy (RT)
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Anne Wiley
6507256432