Combination Chemotherapy Plus Low-Dose Radiation Therapy in Treating Patients With Stage I or Stage IIA Hodgkin's Lymphoma
Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
Details and patient eligibility
About
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.
Full description
OBJECTIVES:
- Evaluate the freedom from progression in patients with stage I or IIA Hodgkin's lymphoma with a favorable prognosis treated with "Stanford V-C" chemotherapy comprising cyclophosphamide, doxorubicin, vinblastine, prednisone, vincristine, bleomycin, and etoposide with low-dose radiotherapy (RT).
- Minimize the early and late effects of treatment in these patients by avoiding staging laparotomy and its consequences, limiting cumulative doses of chemotherapy, and reducing the dose of RT to moderately bulky sites of disease.
- Assess early and late treatment-related toxicity, freedom from second disease progression, and overall survival at 5 and 10 years in patients treated with this regimen.
Participants receive Stanford V-C chemotherapy comprising cyclophosphamide IV over 30 to 60 minutes weekly on weeks 1 and 5; doxorubicin IV and vinblastine IV over 5 minutes once weekly on weeks 1, 3, 5, and 7; oral prednisone every other day on weeks 1 to 8; vincristine IV, and bleomycin IV over 5 minutes once weekly on weeks 2, 4, 6, and 8; and etoposide IV over 60 minutes on days 1 and 2 of weeks 3 and 7. Prior to protocol amendment, participants were assigned to treatment on the basis of tumor size (< 5 cm vs 5 to 10 cm), with only the participants with larger tumors receiving RT. Beginning 2 to 3 weeks after completion of chemotherapy, participants in the +RT group will receive low-dose radiotherapy 5 days a week for approximately 3 weeks. Subsequent to amendment, all participants received RT.
Participants are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
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Diagnosis of previously untreated stage I or IIA Hodgkin's lymphoma, eligible subtypes
- Nodular sclerosis
- Mixed cellularity
- Classical, not otherwise specified
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Age ≥ 18 years and ≤ 70 years
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Granulocytes ≥ 2 x 10e6/µL
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Platelets ≥ 150 x 10e6/µL
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Bilirubin ≤ 2.5 mg/dL
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Serum creatinine ≤ 2 mg/dL
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Patients > 50 years or those with a history of cardiac disease should have an ejection fraction ≥ 50%
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All scans, X-rays, laboratory tests must be performed within 6 weeks of enrollment
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Pathologic material reviewed at Stanford University
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Evaluation by Stanford Medical Oncology and Radiation Oncology with review at the Hodgkin's Disease Staging Conference
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Written informed consent
Exclusion criteria
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Lymphocytic predominance Hodgkin's disease
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Prior treatment for Hodgkin's disease
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Mediastinal mass equal to or greater than one-third the maximum intrathoracic diameter on a standing posteroanterior chest x-ray
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Any lymph node mass > 10 cm in greatest trans-axial diameter
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Two or more extranodal sites of disease
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Constitutional (B) symptoms present at diagnosis
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Prior or concurrent malignancies within 5 years (EXCEPTION: basal cell carcinoma of the skin)
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Any medical contraindication to the planned treatment, including:
- Pregnant
- Positive antibody test for the human immunodeficiency virus (HIV)
Trial design
Primary purpose
Allocation
Interventional model
Masking
76 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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