Feasibility of an Immediate Preoperative Chemotherapy Before Resection fo Colorectal Cancer

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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01715363

Acronym

PRIMM

Enrollment

Registered

2012-10-26

Start date

2012-07-31

Completion date

2014-06-30

Last updated

2016-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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

Interventions

DRUGOxaliplatin

DRUGFolinic Acid

DRUGFluorouracile

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Clinical tolerance of immediate preoperative chemotherapy	Assess up to 30 days after surgery	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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026