Feasibility of an Immediate Preoperative Chemotherapy Before Resection fo Colorectal Cancer

• Status: Terminated
• Trial end date: 2014-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to analyze the clinical tolerance of immediate preoperative chemotherapy in terms of toxicity and perioperative morbidity and mortality

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gustave Roussy, Cancer Campus, Grand Paris
• Treatments: Folic Acid; Leucovorin; Levoleucovorin; Oxaliplatin

Criteria

Inclusion Criteria:

• colorectal metastatic adenocarcinoma (stage IV) with unresectables, measurables and visibles secondary lesions

• primitive tumor must be operate

• patient age between 18 and 70

• OMS status performance < 2

• life expectancy > 12 weeks

• hematologic function : PNN >/= 1.5x10^9/L, platelets >/= 100x10^9/L

• hepatic function : bilirubin
• plasmatimic creatin
• No previous chemotherapy or pelvic radiotherapy

• men and women in age of procreate agreeing to use a contraception until 4 months after the end of treatment for women and until 6 months for men

Exclusion Criteria:

• nonmetastatic forms

• Colorectal tumor which requires preoperative radiotherapy

• nonmeasurable metastasis based on RECIST criteria

• previous chemotherapy for colorectal cancer

• previous irradiation of the primitive tumour

• specific indication against the treatment studied

• Patient considered as inoperable for physiological or carcinologic reasons

• Pregnant or breast feeding women