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Trial record 4 of 5 for:    "Gastric lymphoma"

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

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ClinicalTrials.gov Identifier: NCT00204659
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : October 20, 2008
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by:
University Hospital Tuebingen

Brief 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.

Condition or disease Intervention/treatment Phase
Primary Gastric Diffuse-Large B-Cell Lymphoma Drug: Rituximab + CHOP chemotherapy Phase 2

Detailed Description:
see above

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study With Rituximab and CHOP in Patients With Gastric Diffuse Large B-Cell Non-Hodgkin`s Lymphoma
Study Start Date : March 2003
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008



Intervention Details:
  • Drug: Rituximab + CHOP chemotherapy
    standard Rituximab + CHOP chemo-immunotherapy
    Other Name: MabThera


Primary Outcome Measures :
  1. Complete remission rate [ Time Frame: at end of chemo-immunotherapy ]
  2. Progression-free survival [ Time Frame: at 2 and 5 years ]

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: at 2 and 5 years ]
  2. Toxicity [ Time Frame: after chemo-immunotherapy ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00204659


Locations
Germany
Zentralklinikum Augsburg
Augsburg, Germany, 86156
University of Giessen
Giessen, Germany, 35392
Klinikum Reutlingen
Reutlingen, Germany
University of Tubingen
Tuebingen, Germany, 72076
Schwarzwald-Baar Clinic
Villingen-Schwenningen, Germany, 78050
Sponsors and Collaborators
University Hospital Tuebingen
Hoffmann-La Roche
Investigators
Principal Investigator: Wolfram Brugger, M.D. Schwarzwald-Baar Clinic, Academic Teaching Hospital, University of Freiburg

Responsible Party: Wolfram Brugger, M.D., Schwarzwald-Baar Clinic, Academic Teaching Hospital, Univ. Freiburg
ClinicalTrials.gov Identifier: NCT00204659     History of Changes
Other Study ID Numbers: 64-03
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: October 20, 2008
Last Verified: September 2008

Keywords provided by University Hospital Tuebingen:
Rituximab
CHOP
DLBCL
gastric lymphoma

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Rituximab
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents