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

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00180960
First Posted: September 16, 2005
Last Update Posted: September 11, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Gustave Roussy, Cancer Campus, Grand Paris
  Purpose

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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00180960


Locations
France
Institut Gustave-Roussy
Villejuif, France, 94800
Sponsors and Collaborators
Gustave Roussy, Cancer Campus, Grand Paris
Investigators
Principal Investigator: Dominique Elias, MD Gustave Roussy, Cancer Campus, Grand Paris
  More Information

ClinicalTrials.gov Identifier: NCT00180960     History of Changes
Other Study ID Numbers: CHIP4 Phase II
First Submitted: September 13, 2005
First Posted: September 16, 2005
Last Update Posted: September 11, 2006
Last Verified: September 2006

Additional relevant MeSH terms:
Neoplasms
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
Oxaliplatin
Irinotecan
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action