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

G

Gustave Roussy

Status and phase

Terminated
Phase 2

Conditions

Endocrine Tumors
Colon Tumors
Peritoneum Tumors
Appendix Tumors
Rectum Tumors

Treatments

Drug: Oxaliplatin and irinotecan

Study type

Interventional

Funder types

Other

Identifiers

NCT00180960
CHIP4 Phase II

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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