Clinical trial NCT00026208
Conditions: Lymphoma, Hodgkin Disease Lymphoma Hodgkin Disease Lymphoma: Hodgkin
Sponsor: Stanford University
Start date: 2001-06-01; Completion date: 2017-02-13
Enrollment: 76 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief 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.

Detailed 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.

Arms: arm 1: "Sanford V-C" = Vinblastine, cyclophosphamide, doxorubicin, prednisone, bleomycin, + etoposide.

Radiotherapy = 20 Gy modified involved field radiotherapy arm 2: "Sanford V-C" = Vinblastine, cyclophosphamide, doxorubicin, prednisone, bleomycin, + etoposide.
Interventions: intervention 1: Vincristine intervention 2: Cyclophosphamide intervention 3: Doxorubicin intervention 4: Prednisone intervention 5: Bleomycin intervention 6: Etoposide intervention 7: Low-dose radiotherapy (RT)
Intervention descriptions: intervention 1: 1.4 mg/m² intravenously (IV) on week 2, 4, 6, 8 intervention 2: 650 mg/m², on week 1 and 5 intervention 3: 25 mg/m², on week 1, 3, 5, 7 intervention 4: 40 mg/m², oral, every other day. Taper-reduction 10 mg/m² every other day during last 2 weeks of chemotherapy intervention 5: 5 u/m² intravenously (IV) on week 2, 4, 6, 8 intervention 6: 60 mg/m² x 2 intravenously (IV) on week 3, 7 (d 15, 16, 43, 44) intervention 7: 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.

Protocol documents: