Feasibility of an Immediate Preoperative Chemotherapy Before Resection fo Colorectal Cancer

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

— PRIMM  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01715363
• Other study ID #: 2011-003446-41
• Secondary ID: 2010/1676
• Status: Terminated
• Phase: Phase 2
• First received: October 24, 2012
• Last updated: February 9, 2016
• Start date: July 2012
• Est. completion date: June 2014

Study information

• Verified date: February 2016
• Source: Gustave Roussy, Cancer Campus, Grand Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• Oxaliplatin

• Folinic Acid

• Fluorouracile

Locations

Country	Name	City	State
France	Institut Gustave Roussy	Villejuif	Val de Marne

Sponsors (1)

Lead Sponsor	Collaborator
Gustave Roussy, Cancer Campus, Grand Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No