Feasibility of an Immediate Preoperative Chemotherapy Before Resection fo Colorectal Cancer

Phase 2TerminatedNCT01715363

Gustave Roussy, Cancer Campus, Grand Paris3 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Patients With Colorectal Cancer With Unresectable Synchronous Metastasis in Whom Resection of the Primitive Tumour is Indicated

Interventions

OxaliplatinDRUG

Folinic AcidDRUG

FluorouracileDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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 \</= 1.5xLSN, AST and ALT \</= 3xLSN, alcalin phosphatasis \</= 3xLSN * plasmatimic creatin \</= 1.25xLSN * 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

Locations (1)

Institut Gustave Roussy

Villejuif, Val de Marne, France

Outcomes

Primary Outcomes

Clinical tolerance of immediate preoperative chemotherapy

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

Time frame: Assess up to 30 days after surgery

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.