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Treatment of a Cancerous Disease of the Peritoneum With Complete Cytoreductive Surgery With Intraperitoneal Chemohyperthermia Using Oxaliplatin Plus Irinotecan


Phase 2
18 Years
65 Years
Not Enrolling
Both
Colon Tumors, Rectum Tumors, Appendix Tumors, Peritoneum Tumors, Endocrine Tumors

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Trial Information

Treatment of a Cancerous Disease of the Peritoneum With Complete Cytoreductive Surgery With Intraperitoneal Chemohyperthermia Using Oxaliplatin Plus Irinotecan


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To study overall survival

Principal Investigator

Dominique Elias, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Gustave Roussy, Cancer Campus, Grand Paris

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

CHIP4 Phase II

NCT ID:

NCT00180960

Start Date:

June 2003

Completion Date:

Related Keywords:

  • Colon Tumors
  • Rectum Tumors
  • Appendix Tumors
  • Peritoneum Tumors
  • Endocrine Tumors
  • Appendiceal Neoplasms
  • Colonic Neoplasms
  • Endocrine Gland Neoplasms
  • Peritoneal Diseases
  • Rectal Neoplasms

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