Treatment of a Cancerous Disease of the Peritoneum With Complete Cytoreductive Surgery and Intraperitoneal Chemohyperthermia

Phase 2

Terminated

• Conditions: Colon Tumors; Rectum Tumors; Appendix Tumors; Peritoneum Tumors; Endocrine Tumors

• Registration Number: NCT00180960
• Lead Sponsor: Gustave Roussy, Cancer Campus, Grand Paris

Brief Summary

The purpose of this study is to evaluate the treatment of a cancerous disease of the peritoneum with complete cytoreductive surgery with intraperitoneal chemohyperthermia using oxaliplatin plus irinotecan.

This is a Phase II study with 100 patients. Origins of the tumors: these include colon, rectum, appendix, peritoneum, and endocrine tumors.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-06
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-16
• Status Verified: 2006-09
• Last Update Submitted: 2006-09-07
• Last Update Posted: 2006-09-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Peritoneal seedings coming from colon, rectum, pseudomyxoma (appendix), peritoneum (mesothelioma and serous tumors), or endocrine tumors.
• No extra-abdominal metastases
• Good general status (American Society of Anesthesiologists Physical Status score [ASA] 1 or 2)
• Signed consent

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Exclusion Criteria

• Tumor seedings coming from other origins
• Huge peritoneal carcinomatosis (peritoneal score > 25, except for pseudomyxomas)
• Peritoneal carcinomatosis progressing rapidly
• Presence of extra-abdominal metastases
• Patients presenting contraindications to the use of oxaliplatin or irinotecan

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
To study overall survival

Secondary Outcome Measures

Name	Time	Method
To study mortality-morbidity

Trial Locations

Locations (1)

Institut Gustave-Roussy; 🇫🇷 Villejuif, France