- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04879953
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
Status
Completed
Conditions
Intervention / Treatment
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- pipac
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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