Feasibility of an Immediate Preoperative Chemotherapy Before Resection of Colorectal Cancer and Research of Gene Expressions Changes Induced in the Tumor, Predictive of Chemotherapy Efficiency
18 Years
70 Years
Both
Patients With Colorectal Cancer With Unresectable Synchronous Metastasis in Whom Resection of the Primitive Tumour is Indicated
Trial Information
Feasibility of an Immediate Preoperative Chemotherapy Before Resection of Colorectal Cancer and Research of Gene Expressions Changes Induced in the Tumor, Predictive of Chemotherapy Efficiency
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Clinical tolerance of immediate preoperative chemotherapy
Outcome Description:
Clinical tolerance of immediate preoperative chemotherapy assessment is based on the post-operative complication rate in terms of morbidity and mortality. All the post-operative complications arising within 30 days after surgery will be registered and classified using the Clavien Dindo classification
Outcome Time Frame:
Assess up to 30 days after surgery
Safety Issue:
No
Principal Investigator
Diane GOERE, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Gustave Roussy, Cancer Campus, Grand Paris
Authority:
France: Agence Nationale de Sécurité du Médicament et des produits de santé
Study ID:
2011-003446-41
NCT ID:
NCT01715363
Start Date:
July 2012
Completion Date:
December 2014
Related Keywords:
- Patients With Colorectal Cancer With Unresectable Synchronous Metastasis in Whom Resection of the Primitive Tumour is Indicated
- Colorectal Neoplasms
- Neoplasm Metastasis
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