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

May 10, 2021 updated by: Pr Catherine Arvieux, Association Francaise de Chirurgie

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

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.

Study Overview

Study Type

Observational

Enrollment (Actual)

46

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Grenoble, France
        • CHUGA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
PIPAC CHEM
PIPAC associated with systemic chemotherapy
PIPAC procedures were performed every 6 to 8 weeks, alternating with systemic chemotherapy, replacing a cycle of intravenous chemotherapy.
ONLY CHEM
systemic chemotherapy alone
Intravenous chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival at 6 months
Time Frame: 6 months
Overall survival at 6 months from diagnosis of carcinomatosis
6 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Catherine Arvieux, Grenoble Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2020

Primary Completion (Actual)

August 30, 2020

Study Completion (Actual)

December 31, 2020

Study Registration Dates

First Submitted

May 5, 2021

First Submitted That Met QC Criteria

May 7, 2021

First Posted (Actual)

May 10, 2021

Study Record Updates

Last Update Posted (Actual)

May 11, 2021

Last Update Submitted That Met QC Criteria

May 10, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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