Feasibility of an Immediate Preoperative Chemotherapy Before Resection fo Colorectal Cancer (PRIMM)
Primary Purpose
Patients With Colorectal Cancer With Unresectable Synchronous Metastasis in Whom Resection of the Primitive Tumour is Indicated
Status
Terminated
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Oxaliplatin
Folinic Acid
Fluorouracile
Sponsored by

About this trial
This is an interventional treatment trial for Patients With Colorectal Cancer With Unresectable Synchronous Metastasis in Whom Resection of the Primitive Tumour is Indicated
Eligibility 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 </= 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
Sites / Locations
- Institut Gustave Roussy
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
FOLFOX + surgery + FOLFOX
Arm Description
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)
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT01715363
First Posted
October 24, 2012
Last Updated
February 9, 2016
Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
1. Study Identification
Unique Protocol Identification Number
NCT01715363
Brief Title
Feasibility of an Immediate Preoperative Chemotherapy Before Resection fo Colorectal Cancer
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Terminated
Why Stopped
Recruitment difficulties
Study Start Date
July 2012 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patients With Colorectal Cancer With Unresectable Synchronous Metastasis in Whom Resection of the Primitive Tumour is Indicated
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
FOLFOX + surgery + FOLFOX
Arm Type
Experimental
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Intervention Type
Drug
Intervention Name(s)
Folinic Acid
Intervention Type
Drug
Intervention Name(s)
Fluorouracile
Primary Outcome Measure Information:
Title
Clinical tolerance of immediate preoperative chemotherapy
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
Time Frame
Assess up to 30 days after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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 </= 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Diane GOERE, MD
Organizational Affiliation
Gustave Roussy, Cancer Campus, Grand Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut Gustave Roussy
City
Villejuif
State/Province
Val de Marne
ZIP/Postal Code
94805
Country
France
12. IPD Sharing Statement
Learn more about this trial
Feasibility of an Immediate Preoperative Chemotherapy Before Resection fo Colorectal Cancer
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