Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy in Peritoneal Carcinomatosis From Gastric Cancer

Completed

• Conditions: Gastric Cancer; Peritoneal Carcinomatosis
• Interventions: Procedure: Cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy procedure; Procedure: Cytoreductive surgery alone

• Registration Number: NCT03253939
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

Gastric cancer associated peritoneal carcinomatosis has a poor prognosis with a median survival of less than one year. Systemic chemotherapy including targeted agents has not been found to significantly increase the survival in Gastric cancer associated peritoneal carcinomatosis. Since recurrent gastric cancer remains confined to the abdominal cavity in many patients, regional therapies like aggressive cytoreductive surgery and hyperthermic intraperitoneal chemotherapy have been investigated for Gastric cancer associated peritoneal carcinomatosis. Hyperthermic intraperitoneal chemotherapy has been used for three indications in Gastric Cancer- as an adjuvant therapy after a curative surgery, hyperthermic intraperitoneal chemotherapy has been shown to improve survival and reduce peritoneal recurrences in many randomised trials in Asian countries; as a definitive treatment in established PC, hyperthermic intraperitoneal chemotherapy along with cytoreductive surgery is the only therapeutic modality that has resulted in long-term survival in select groups of patients. While the results of randomised trials of adjuvant hyperthermic intraperitoneal chemotherapy from western centres are awaited, the role of hyperthermic intraperitoneal chemotherapy in the treatment of Gastric cancer associated peritoneal carcinomatosis is still evolving and needs larger studies before it is accepted as a standard of care.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-02-01
• Status Verified: 2017-07
• Primary Completion: 2017-07-01
• Study Completion: 2017-07-01
• Study First Submitted: 2017-07-27
• Study First Submitted QC: 2017-08-17
• Last Update Submitted: 2017-08-17
• Study First Posted: 2017-08-18
• Last Update Posted: 2017-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 275

Inclusion Criteria

• Confirmed peritoneal carcinomatosis from gastric cancer
• Metachronous/synchronous peritoneal carcinomatosis

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Exclusion Criteria

• Gastric origin of peritoneal carcinomatosis unconfirmed

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Case group	Cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy procedure	Cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy procedure
Control group	Cytoreductive surgery alone	Cytoreductive surgery alone

Primary Outcome Measures

Name	Time	Method
3-years overall survival	3 years	From the date of Cytoreductive surgery + hyperthermic intraperitoneal chemotherapy to death or to the end of follow-up

Trial Locations

Locations (1)

Service de Chirurgie Générale et Digestive - Centre Hospitalier Lyon Sud - Hospices Civils de Lyon; 🇫🇷 Pierre-Bénite, France