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

Gastric Cancer Clinical Trial

— CYTO-CHIP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03253939
• Other study ID #: CYTO-CHIP
• Status: Completed
• Phase: N/A
• First received: July 27, 2017
• Last updated: August 17, 2017
• Start date: February 1, 2017
• Est. completion date: July 1, 2017

Study information

• Verified date: July 2017
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 275
• Est. completion date: July 1, 2017
• Est. primary completion date: July 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

Inclusion Criteria:

• Confirmed peritoneal carcinomatosis from gastric cancer

• Metachronous/synchronous peritoneal carcinomatosis

Exclusion Criteria:

• Gastric origin of peritoneal carcinomatosis unconfirmed

Related Conditions & MeSH terms

• Carcinoma
• Fever
• Gastric Cancer
• Peritoneal Carcinomatosis
• Stomach Neoplasms

Intervention

Procedure:
• Cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy procedure
Cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy procedure
• Cytoreductive surgery alone
Exclusively Cytoreductive surgery approach

Locations

Country	Name	City	State
France	Service de Chirurgie Générale et Digestive - Centre Hospitalier Lyon Sud - Hospices Civils de Lyon	Pierre-Bénite

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3-years overall survival	From the date of Cytoreductive surgery + hyperthermic intraperitoneal chemotherapy to death or to the end of follow-up	3 years