Feasibility of an Immediate Preoperative Chemotherapy Before Resection fo Colorectal Cancer (PRIMM)

Gustave Roussy

Status and phase: Terminated; Phase 2

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

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01715363

2010/1676 (Other Identifier)

2011-003446-41

Details and patient eligibility

About

The purpose of this study is to analyze the clinical tolerance of immediate preoperative chemotherapy in terms of toxicity and perioperative morbidity and mortality

Enrollment: 3 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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3 participants in 1 patient group

FOLFOX + surgery + FOLFOX

Experimental group

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)

Treatment:

Drug: Folinic Acid

Drug: Oxaliplatin

Drug: Fluorouracile