Feasibility of an Immediate Preoperative Chemotherapy Before Resection fo Colorectal Cancer

NCT01715363 | Terminated Phase 2

• 2 other identifiers: 2011-003446-412010/1676
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

  Assess up to 30 days after surgery

Study Arms (1)

FOLFOX + surgery + FOLFOX

EXPERIMENTAL

* Systemic chemotherapy (modified FOLFOX 4) 48 hours before surgery * resection of the colorectal tumor during surgery * Resumption of FOLFOX within the month after surgery (post operative administration of 4 course of treatment and assessment of the response)

Drug: Oxaliplatin; Drug: Folinic Acid; Drug: Fluorouracile

Interventions

Oxaliplatin DRUG

FOLFOX + surgery + FOLFOX

Folinic Acid DRUG

FOLFOX + surgery + FOLFOX

Fluorouracile DRUG

FOLFOX + surgery + FOLFOX

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gustave Roussy, Cancer Campus, Grand Paris: lead

Study Sites (1)

Institut Gustave Roussy

Villejuif, Val de Marne, 94805, France

Location

MeSH Terms

Interventions

Oxaliplatin; Leucovorin; Fluorouracil

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Coenzymes; Enzymes and Coenzymes; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Diane GOERE, MD

  Gustave Roussy, Cancer Campus, Grand Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2012
• First Posted: October 26, 2012
• Study Start: July 1, 2012
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: February 10, 2016

Record last verified: 2016-02

Locations

FR (1)