drugset / Trial / NCT00005089

S0014 Combination Chemotherapy Plus Rituximab and Radiation Therapy in Treating Patients With Stage I or Stage II Non-Hodgkin's Lymphoma

NCT00005089 ↗

NaSingle-groupOpen-labelTreatment

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies, such as rituximab, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Radiation therapy uses high-energy x-rays to damage cancer cells. Combining chemotherapy with monoclonal antibody therapy and radiation therapy may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus rituximab and radiation therapy in treating patients who have stage I or stage II non-Hodgkin's lymphoma.

Timeline

Start
2000-04
Primary completion
2004-11
Completion
2014-04

Outcome

Met primary endpoint

paper met prespecified study criteria of efficacy, with 2-year PFS of at least 84%, meriting further investigation. PMID 18413640 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Cyclophosphamide Other / unclassified 750 mg/m2 Intravenous
Subject Doxorubicin Other / unclassified 50 mg/m2 Intravenous
Subject Prednisone Other / unclassified 100 mg Oral
Subject Rituximab Monoclonal antibody 375 mg/m2 Intravenous
Subject Vincristine Small molecule 1.4 mg/m2 Intravenous

Indications