A Phase 2 interventional study of CHOP regimen and cyclophosphamide in Lymphoma and Small Intestine Cancer, sponsored by European Organisation for Research and Treatment of Cancer - EORTC. Completed at 6 sites in 5 countries. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2012-09-24.
Sponsored by European Organisation for Research and Treatment of Cancer - EORTC · Phase 2, Interventional, and Treatment
RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin, vincristine, prednisone, and gemcitabine, work in different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one chemotherapy drug may kill more cancer cells.
PURPOSE: This randomized phase II trial is studying giving combination chemotherapy together with gemcitabine to see how well it works compared to giving combination chemotherapy alone in treating patients with previously untreated aggressive stage II, stage III, or stage IV non-Hodgkin's lymphoma.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label, randomized, multicenter study. Patients are stratified according to participating center, International Prognostic Index score (0-2 vs 3-5), and histology (B cell vs T cell). Patients are randomized to 1 of 2 treatment arms.
In both arms, treatment repeats every 3 weeks for 3 courses in the absence of unacceptable toxicity or progressive disease. Patients achieving partial response or complete or unconfirmed complete response receive an additional 5 courses of therapy (for a total of 8 courses).
Patients are followed every 3 months for 3 years, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 76-82 patients (38-41 per treatment arm) will be accrued for this study within 2 years.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's enrollment of 25 is below the median of 40 across 4,508 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →European Organisation for Research and Treatment of Cancer - EORTC is the lead sponsor of 342 studies on the registry; 23 are open to participants now.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Histologically confirmed aggressive non-Hodgkin's lymphoma (NHL) of 1 of the following WHO subtypes:
The following subtypes are not allowed:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Complete response as assessed by Cheson criteria
Toxicity as assessed by CTC 2.0
Proportion of courses given as scheduled
Freedom from treatment failure as assessed by Cheson criteria
This study is completed, as verified in Sep 2012. You cannot join it, but the record below documents what was studied.
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European Organisation for Research and Treatment of Cancer - EORTC