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

NCT04879953 | Completed

• 1 other identifier: PIPAC
• Study Type: observational
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Carcinomatosis, Peritoneal

Outcome Measures

Primary Outcomes (1)

• Overall survival at 6 months

  Overall survival at 6 months from diagnosis of carcinomatosis

  6 months

Secondary Outcomes (2)

• Duration of hospital stay

  6 months

• overall survival from the diagnosis of carcinomatosis and from the diagnosis of the primary tumour.

  3 years

Study Arms (2)

PIPAC CHEM

PIPAC associated with systemic chemotherapy

Drug: PIPAC with systemic chemotherapy

ONLY CHEM

systemic chemotherapy alone

Drug: Systemic chemotherapy alone

Interventions

PIPAC with systemic chemotherapy DRUG

PIPAC procedures were performed every 6 to 8 weeks, alternating with systemic chemotherapy, replacing a cycle of intravenous chemotherapy.

PIPAC CHEM

Systemic chemotherapy alone DRUG

Intravenous chemotherapy

ONLY CHEM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consisted of adult patients with adenocarcinoma-type gastric non-resectable PC, without metastasis other than peritoneal, treated either with PIPAC administered in alternation with systemic chemotherapy or by systemic chemotherapy alone. All patients receiving PIPAC in our hospital during the study period were included. The patients in the group had been treated during the same period and were carefully selected according to age, general state of health (WHO performance status \<3) and absence of extra-peritoneal metastases so as to match as closely as possible the patients in the PIPAC group.

You may qualify if:

• 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

You may not qualify if:

• \- Patients opposed

Sponsors & Collaborators

• Association Francaise de Chirurgie: lead

Study Sites (1)

CHUGA

Grenoble, France

Location

MeSH Terms

Conditions

Peritoneal Neoplasms

Condition Hierarchy (Ancestors)

Abdominal Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Peritoneal Diseases

Study Officials

• Catherine Arvieux

  Grenoble Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professeur

Study Record Dates

• First Submitted: May 5, 2021
• First Posted: May 10, 2021
• Study Start: February 1, 2020
• Primary Completion: August 30, 2020
• Study Completion: December 31, 2020
• Last Updated: May 11, 2021

Record last verified: 2021-05

Locations

FR (1)