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

This study has been terminated.
Information provided by:
Gustave Roussy, Cancer Campus, Grand Paris Identifier:
First received: September 13, 2005
Last updated: September 7, 2006
Last verified: September 2006

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.

Condition Intervention Phase
Colon Tumors Rectum Tumors Appendix Tumors Peritoneum Tumors Endocrine Tumors Drug: Oxaliplatin and irinotecan Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of a Cancerous Disease of the Peritoneum With Complete Cytoreductive Surgery With Intraperitoneal Chemohyperthermia Using Oxaliplatin Plus Irinotecan

Resource links provided by NLM:

Further study details as provided by Gustave Roussy, Cancer Campus, Grand Paris:

Primary Outcome Measures:
  • To study overall survival

Secondary Outcome Measures:
  • To study mortality-morbidity

Estimated Enrollment: 100
Study Start Date: June 2003

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00180960

Institut Gustave-Roussy
Villejuif, France, 94800
Sponsors and Collaborators
Gustave Roussy, Cancer Campus, Grand Paris
Principal Investigator: Dominique Elias, MD Gustave Roussy, Cancer Campus, Grand Paris
  More Information Identifier: NCT00180960     History of Changes
Other Study ID Numbers: CHIP4 Phase II
Study First Received: September 13, 2005
Last Updated: September 7, 2006

Additional relevant MeSH terms:
Endocrine Gland Neoplasms
Appendiceal Neoplasms
Neoplasms by Site
Endocrine System Diseases
Cecal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Cecal Diseases
Intestinal Diseases
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on September 18, 2017