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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
Gustave Roussy, Cancer Campus, Grand Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
October 24, 2012
Last Updated
February 9, 2016
Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
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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

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Feasibility of an Immediate Preoperative Chemotherapy Before Resection fo Colorectal Cancer

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