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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

NCT ID: NCT00204659

Last Updated: 2008-10-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-03-31

Study Completion Date

2008-09-30

Brief Summary

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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.

Detailed Description

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see above

Conditions

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Primary Gastric Diffuse-Large B-Cell Lymphoma

Keywords

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Rituximab CHOP DLBCL gastric lymphoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Rituximab + CHOP chemotherapy

standard Rituximab + CHOP chemo-immunotherapy

Intervention Type DRUG

Other Intervention Names

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MabThera

Eligibility Criteria

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Inclusion Criteria

* Age \> 18 years
* Histologically confirmed primary gastric CD20+ DLBCL
* Written informed consent
* ECOG 0-2

Exclusion Criteria

* Secondary aggressive Non-Hodgkin's lymphoma involving the gastric area
* HIV positive patients
* Severe organ dysfunction
* Life expectancy of less than 3 months
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role collaborator

University Hospital Tuebingen

OTHER

Sponsor Role lead

Responsible Party

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Schwarzwald-Baar Clinic, Academic Teaching Hospital, Univ. Freiburg

Principal Investigators

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Wolfram Brugger, M.D.

Role: PRINCIPAL_INVESTIGATOR

Schwarzwald-Baar Clinic, Academic Teaching Hospital, University of Freiburg

Locations

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Zentralklinikum Augsburg

Augsburg, , Germany

Site Status

University of Giessen

Giessen, , Germany

Site Status

Klinikum Reutlingen

Reutlingen, , Germany

Site Status

University of Tubingen

Tübingen, , Germany

Site Status

Schwarzwald-Baar Clinic

Villingen-Schwenningen, , Germany

Site Status

Countries

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Germany

Other Identifiers

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64-03

Identifier Type: -

Identifier Source: org_study_id