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

NCT00005089 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 71

Last updated 2017-01-16

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

rituximab

375 mg/m\^2 on days 1,8 of cycle 1, then on days 1-3 of cycles 2-3.

DRUG

cyclophosphamide

750 mg/m\^2 on day 10 of cycle 1, then on day 21 of cycles 2-3.

DRUG

doxorubicin hydrochloride

50 mg/m\^2 on day 10 of cycle 1, then on day 21 of cycles 2-3.

DRUG

prednisone

100 mg on days 10-14 of cycle 1, then on days 3-7 of cycles 2-3.

DRUG

vincristine sulfate

1.4 mg/m\^2 on day 10 of cycle 1, then on day 3 of cycles 2-3.

RADIATION

radiation therapy

4000-5500 cGy given in 25 fractions starting 3 weeks after completion of CHOP + Rituximab.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH
  • SWOG Cancer Research Network

    lead NETWORK

Principal Investigators

  • Thomas P. Miller, MD · University of Arizona

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-04-30
Primary Completion
2004-11-30
Completion
2014-04-30

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00005089 on ClinicalTrials.gov