Combination Chemotherapy Plus Low-Dose Radiation Therapy in Treating Patients With Stage I or Stage IIA Hodgkin's Lymphoma
|ClinicalTrials.gov Identifier: NCT00026208|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : March 6, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma, Hodgkin Disease Lymphoma Hodgkin Disease Lymphoma: Hodgkin||Drug: bleomycin Drug: cyclophosphamide Drug: prednisone Drug: vincristine Drug: Adriamycin Drug: Velban Drug: VP-16||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||76 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Risk Adapted Stanford V-C With Radiotherapy for Clinical Stage I and IIA Favorable Hodgkin's Disease: The G5 Study|
|Study Start Date :||June 2001|
|Primary Completion Date :||February 13, 2017|
|Study Completion Date :||February 13, 2017|
|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)
- Progression-free survival by Kaplan-Meier [ Time Frame: at completion of therapy and then annually for 3 years ]
- Early and late treatment-related toxicity [ Time Frame: Duration of study ]
- Freedom from second disease progression by Kaplan-Meier [ Time Frame: at completion of therapy and then annually for 3 years ]
- Overall survival by Kaplan-Meier [ Time Frame: at 5 and 10 years ]
- Frequency of complete response by positron-emission tomography scan [ Time Frame: between weeks 4 and 5 of chemotherapy ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:||Ranjana Advani||Stanford University|