Primary Gastric Diffuse-Large B-Cell Lymphoma
Conditions
Keywords
Rituximab, CHOP, DLBCL, gastric lymphoma
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.
Detailed description
see above
Interventions
DRUGRituximab + CHOP chemotherapy
standard Rituximab + CHOP chemo-immunotherapy
Sponsors
Hoffmann-La Roche
University Hospital Tuebingen
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete remission rate | at end of chemo-immunotherapy |
| Progression-free survival | at 2 and 5 years |
Secondary
| Measure | Time frame |
|---|---|
| Toxicity | after chemo-immunotherapy |
| Overall survival | at 2 and 5 years |
Countries
Germany
Outcome results
None listed