Overview

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

Status:
Terminated
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Gustave Roussy, Cancer Campus, Grand Paris
Treatments:
Irinotecan
Oxaliplatin
Criteria
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

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