Combination Chemotherapy Plus Low-Dose Radiation Therapy in Treating Patients With Stage I or Stage IIA Hodgkin's Lymphoma
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 II 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.
Lymphoma, Hodgkin Disease
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Risk Adapted Stanford V-C With Radiotherapy for Clinical Stage I and IIA Favorable Hodgkin's Disease: The G5 Study|
- Progression-free survival by Kaplan-Meier [ Time Frame: at completion of therapy and then annually for 3 years ] [ Designated as safety issue: No ]
- Early and late treatment-related toxicity [ Time Frame: Duration of study ] [ Designated as safety issue: Yes ]
- Freedom from second disease progression by Kaplan-Meier [ Time Frame: at completion of therapy and then annually for 3 years ] [ Designated as safety issue: No ]
- Overall survival by Kaplan-Meier [ Time Frame: at 5 and 10 years ] [ Designated as safety issue: No ]
- Frequency of complete response by positron-emission tomography scan [ Time Frame: between weeks 4 and 5 of chemotherapy ] [ Designated as safety issue: No ]
|Study Start Date:||June 2001|
|Estimated Study Completion Date:||March 2017|
|Estimated Primary Completion Date:||March 2017 (Final data collection date for primary outcome measure)|
|Experimental: chemotherapy + Stanford V-C||
5 u/m2 IV week 2, 4, 6, 8Drug: cyclophosphamide
650 mg/m2Drug: prednisone
40 mg/m2, Oral. Every other day. Taper 10 mg qod during last 2 weeks of chemotherapyDrug: vincristine
1.4 mg/m2; IV wk 2, 4, 6, 8Drug: Adriamycin
25 mg/m2Drug: Velban
6 mg/m2, IV wk 1, 3, 5, 7Drug: VP-16
60 mg/m2 x 2; IV wk 3, 7 (d 15, 16, 43, 44)
- 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.
- 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 radiotherapy 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.
OUTLINE: This is a multicenter study.
Patients receive Stanford V-C chemotherapy comprising cyclophosphamide IV over 30-60 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 1-8; 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. Beginning 2-3 weeks after completion of chemotherapy, patients undergo low-dose radiotherapy 5 days a week for approximately 3 weeks.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study within 5 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00026208
|United States, California|
|Stanford University School of Medicine|
|Stanford, California, United States, 94305|
|Kaiser Permanente Medical Center|
|Vallejo, California, United States, 94589|
|Principal Investigator:||Louis Fehrenbacher||Kaiser Permanente Medical Center|