CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 397 enrolled
Drug / intervention
rituximab +10 morebiological
Likely dose
CHOP (cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, prednisone) plus rituximab 375 mg/m² IV every 21 daysAI-extracted
Key inclusion· 7
  • Histologically proven intermediate- or high-grade non-Hodgkin's lymphoma
  • Ann Arbor classification of "bulky" stage II, III, or IV
  • Classified as high-intermediate or high-risk according to International Age Adjusted Index
  • Bidimensionally measurable disease
Key exclusion· 10
  • Lymphoblastic, transformed, or mantle cell lymphomas
  • CNS involvement by lymphoma
  • Prior lymphoma, Hodgkin's lymphoma, myelodysplastic syndromes, or leukemia
  • Prior chemotherapy for lymphoma except single course of CHOP/CHOP-R

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00004031
NCT00004031Phase 3Completed

SWOG-9704 A Randomized Phase III Trial Comparing Early High Dose Chemoradiotherapy and an Autologous Stem Cell Transplant to Conventional Dose CHOP Chemotherapy Plus Rituximab for CD20+ B Cell Lymphomas (With Possible Late Autologous Stem Cell Transplant) for Patients With Diffuse Aggressive Non-Hodgkin's Lymphoma in the High-Intermediate and High Risk International Classification Prognostic Groups

SWOG Cancer Research Network·interventional·Posted Jan 27, 2003·Updated Feb 2, 2021

In Brief

A Phase 3 clinical trial evaluating rituximab, CHOP regimen, and 9 other interventions for Lymphoma. Completed, enrolled 397 participants across 15 sites in 2 countries.

Detailed 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 cancer cells. Peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy and radiation and kill more cancer cells. It is not yet known whether chemoradiotherapy plus peripheral stem cell transplantation is more effective than combination chemotherapy alone in treating non-Hodgkin's lymphoma. PURPOSE: This randomized phase III trial is studying chemoradiotherapy and peripheral stem cell transplantation to see how well they work compared to combination chemotherapy in treating patients with stage II, stage III, or stage IV non-Hodgkin's lymphoma.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLymphoma
CountriesCanada, United States

Timeline

Phase 3CompletedFinished
1997199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 27, 2003
Enrollment StartJul 1, 1997
Primary CompletionJun 1, 2008
Study CompletionOct 31, 2013
TodayJul 2, 2026
Enrollment to primary: 10.9 yearsPosted 23.4 years ago

Interventions

rituximabbiological

375 mg/m2 IV every 21 days

CHOP regimendrug

carmustinedrug

cyclophosphamidedrug

doxorubicin hydrochloridedrug

etoposidedrug

prednisonedrug

vincristine sulfatedrug

bone marrow ablation with stem cell supportprocedure

peripheral blood stem cell transplantationprocedure

radiation therapyradiation