Effect of the PIPAC on the Survival Rate of Patients With Peritoneal Carcinomatosis of Gastric Origin

Completed

• Conditions: Carcinomatosis, Peritoneal
• Interventions: Drug: PIPAC with systemic chemotherapy; Drug: Systemic chemotherapy alone

• Registration Number: NCT04879953
• Lead Sponsor: Association Francaise de Chirurgie

Brief Summary

Pressurised intraperitoneal aerosol chemotherapy is a new surgical technique, developed for the treatment of initially unresectable peritoneal carcinomatosis. The objective of this study was to compare the results of PIPAC associated with systemic chemotherapy with those of systemic chemotherapy alone in patients with gastric peritoneal carcinomatosis without metastasis other than peritoneal, and WHO performance status \<3.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-02-01
• Primary Completion: 2020-08-30
• Study Completion: 2020-12-31
• Status Verified: 2021-05
• Study First Submitted: 2021-05-05
• Study First Submitted QC: 2021-05-07
• Study First Posted: 2021-05-10
• Last Update Submitted: 2021-05-10
• Last Update Posted: 2021-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

• Patients 18 years or over
• Patients with adenocarcinoma-type gastric non-resectable péritonéale carcinomatosis.
• Patients without metastasis other than peritoneal.
• WHO performance status <3
• Patients treated either with PIPAC administered in alternation with systemic chemotherapy (PIPAC_CHEM) or by systemic chemotherapy alone (ONLY_CHEM)
• Patient informed

Exclusion Criteria

• Patients opposed

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PIPAC CHEM	PIPAC with systemic chemotherapy	PIPAC associated with systemic chemotherapy
ONLY CHEM	Systemic chemotherapy alone	systemic chemotherapy alone

Primary Outcome Measures

Name	Time	Method
Overall survival at 6 months	6 months	Overall survival at 6 months from diagnosis of carcinomatosis

Secondary Outcome Measures

Name	Time	Method
Duration of hospital stay	6 months	duration of hospitalization up to 6 months after the diagnosis of carcinomatosis
overall survival from the diagnosis of carcinomatosis and from the diagnosis of the primary tumour.	3 years	overall survival throughout the study follow-up from the diagnosis of carcinomatosis and from the diagnosis of the primary tumour.

Trial Locations

Locations (1)

CHUGA; 🇫🇷 Grenoble, France