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

Study Overview
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Brief Summary
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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.

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

Conditions
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Gastric Cancer, Peritoneal Carcinomatosis

Intervention / Treatment
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* Procedure: Cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy procedure
* Procedure: Cytoreductive surgery alone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Confirmed peritoneal carcinomatosis from gastric cancer Metachronous/synchronous peritoneal carcinomatosis Exclusion Criteria: - Gastric origin of peritoneal carcinomatosis unconfirmed

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Case group<br>Cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy procedure | Procedure: Cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy procedure<br>* Cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy procedure<br>|
| Control group<br>Cytoreductive surgery alone | Procedure: Cytoreductive surgery alone<br>* Exclusively Cytoreductive surgery approach<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3-years overall survival | From the date of Cytoreductive surgery + hyperthermic intraperitoneal chemotherapy to death or to the end of follow-up | 3 years |