Systemic Chemotherapy With or Without Intraperitoneal Chemohyperthermia in Treating Patients Undergoing Surgery for Peritoneal Carcinomatosis From Colorectal Cancer

• Conditions: Patients Undergoing Surgery for Peritoneal Carcinomatosis From Colorectal Cancer; MedDRA version: 14.1Level: LLTClassification code 10052171Term: Peritoneal carcinomaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2006-006175-20-ES
• Lead Sponsor: ICANCER

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12-17
• Last Update Posted: 13 May 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 264

Inclusion Criteria

1) Histologically confirmed colorectal cancer,
2) Minimal or moderate peritoneal carcinosis with a Sugarbaker peritoneal score ? à 25 (see
annex 9), (peroperatory assessment),
3) A surgically obtained tumor reduction, macroscopically complete R1 or with a residual
thickness not exceeding 1 mm (R2), (peroperatory assessment)
4) Absence of extra peritoneal metastases including hepatic and pulmonary metastases (
confirmed by a PET scan, if possible),
5) Patient to be treated by systemic chemotherapy for its carcinosis,
6) 18 ? age ? 70 yo,
7) WHO performance status ? 1,
8) Life expectancy > 12 weeks,
9) Adequate hematological function: polynuclear neutrophiles ? 1,5x10
9
/L, platelets ? 100x10
9
/L,
10) Adequate hepatic function : total bilirubin ? 1,5 x ULN, ASAT (SGOT) and ALAT (SGPT) ? 3 x
ULN, alkaline phosphatases ? 3 x ULN,
11) Seric creatinine ? 1,25 x ULN,
12) Operable patient,
13) Peripheral neuropathy with grade ? 3 (CTC AE v3.0 annex 7)
14) Patient information and written informed consent form signed before any protocol specific
procedure is started.
15) Patient is affiliated with a proper/French national health insurance fund
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 220
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 44

Exclusion Criteria

1) Carcinosis of other-than-colorectal origin, specifically appendiculary carcinomas,
2) Large volume carcinosis with Sugarbaker peritoneal-extent score >25 (annex 9), (peroperatory
assessment)
3) Patient has already been treated by chemohyperthermia
4) History of previous cancer (except cutaneous basocellular carcinoma or in situ carcinoma of
the uterine cervix) with a relapse occurred within the 5-year period prior to inclusion,
5) Patient already included in another first-line therapeutic trial aimed at the same disease study,
6) Pregnant women, women who are likely to become pregnant or are breast-feeding,
7) Individual deprived of liberty or placed under the authority of a tutor,
8) Patients with any psychological, familial, sociological or geographical condition potentially
hampering compliance with the study protocol and follow-up schedule.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified