A Phase 3 interventional study of fluorouracil and irinotecan hydrochloride in Colorectal Cancer, sponsored by Federation Francophone de Cancerologie Digestive. Completed at 77 sites in France. Open to participants aged 75 Years to 120 Years. Per ClinicalTrials.gov, last updated 2016-05-30.
Sponsored by Federation Francophone de Cancerologie Digestive · Phase 3, Interventional, and Treatment
RATIONALE: Drugs used in chemotherapy, such as fluorouracil, leucovorin, and irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) in different doses or combinations may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective in treating colorectal cancer.
PURPOSE: This randomized clinical trial is studying how well fluorouracil works together with leucovorin with or without irinotecan in treating older patients with metastatic colorectal cancer .
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, multicenter, prospective study. Patients are stratified according to participating center, gender, Karnofsky score (60-70% vs 80-90% vs 100%), associated comorbidities (Charlson Index 0 vs 1-2 vs 3+), age (75 to 79 years vs ≥ 80 years), alkaline phosphatase level (≤ 2 times normal vs > 2 times normal), and prior adjuvant chemotherapy (yes vs no). Patients are randomized to 1 of 4 treatment arms.
In all arms, treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
Patients undergo surgery within 3-10 weeks after completing chemotherapy.
Quality of life is assessed at baseline and then every 2 months thereafter.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 282 patients will be accrued for this study.
5,734 studies on the registry are indexed under Colorectal Neoplasms; 1,481 are open to participants now.
This study's enrollment of 282 is above the median of 77 across 4,222 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Federation Francophone de Cancerologie Digestive is the lead sponsor of 63 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the colon or rectum
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
LV5FU2 classique
Drug: fluorouracil · Drug: leucovorin calcium
LV5FU2 classique + irinotécan
Drug: fluorouracil · Drug: irinotecan hydrochloride · Drug: leucovorin calcium
LV5FU2 simplifié
Drug: fluorouracil · Drug: leucovorin calcium
LV5FU2 simplifié + irinotécan
Drug: fluorouracil · Drug: irinotecan hydrochloride · Drug: leucovorin calcium
Progression Free Survival (survie sans progression)
survie sans progression
Time frame: 2011
Overall Survival (survie globale)
survie globale
Time frame: 2011
This study is completed, as verified in May 2016. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Irinotecan
Federation Francophone de Cancerologie Digestive