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

Carcinomatosis, Peritoneal Clinical Trial

Official title:

Effect of Pressurised Intraperitoneal Aerosol Chemotherapy on the Survival Rate of Patients With Peritoneal Carcinomatosis of Gastric Origin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04879953
• Other study ID #: PIPAC
• Status: Completed
• Start date: February 1, 2020
• Est. completion date: December 31, 2020

Study information

• Verified date: May 2021
• Source: Association Francaise de Chirurgie
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: December 31, 2020
• Est. primary completion date: August 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinomatosis, Peritoneal
• Peritoneal Neoplasms

Intervention

Drug:
• PIPAC with systemic chemotherapy
PIPAC procedures were performed every 6 to 8 weeks, alternating with systemic chemotherapy, replacing a cycle of intravenous chemotherapy.
• Systemic chemotherapy alone
Intravenous chemotherapy

Locations

Country	Name	City	State
France	CHUGA	Grenoble

Sponsors (1)

Lead Sponsor	Collaborator
Association Francaise de Chirurgie

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival at 6 months	Overall survival at 6 months from diagnosis of carcinomatosis	6 months
Secondary	Duration of hospital stay	duration of hospitalization up to 6 months after the diagnosis of carcinomatosis	6 months
Secondary	overall survival from the diagnosis of carcinomatosis and from the diagnosis of the primary tumour.	overall survival throughout the study follow-up from the diagnosis of carcinomatosis and from the diagnosis of the primary tumour.	3 years