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Phase II Study With Rituximab and Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (CHOP) in Patients With Gastric Diffuse Large B-Cell Non-Hodgkin's Lymphoma

NCT00204659 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2008-10-20

No results posted yet for this study

Summary

The optimal treatment of primary gastric diffuse large B-cell lymphoma (PG-DLBCL) has not yet been defined. In most circumstances, a stomach-conserving approach is favored, but the role of radiotherapy is still a matter of debate. Recently, Rituximab along with full-dose CHOP chemotherapy has been shown to improve the outcome in elderly patients with nodal DLBCL. However, no data are available with such a therapy in patients with PG-DLBCL. Therefore, in March 2003, we initiated an ongoing, prospective, multicenter phase II study in patients with PG-DLBCL with 6 to 8 cycles of Rituximab (R; 375 mg/m2) plus CHOP-21 in order to evaluate the safety and efficacy of this approach.

Conditions

  • Primary Gastric Diffuse-Large B-Cell Lymphoma

Interventions

DRUG

Rituximab + CHOP chemotherapy

standard Rituximab + CHOP chemo-immunotherapy

Sponsors & Collaborators

Principal Investigators

  • Wolfram Brugger, M.D. · Schwarzwald-Baar Clinic, Academic Teaching Hospital, University of Freiburg

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-03-31
Primary Completion
2008-09-30
Completion
2008-09-30

Countries

  • Germany

Study Locations

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Entities

Companies

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 NCT00204659 on ClinicalTrials.gov