Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) in Gastric Carcinomatosis. Phase II Randomized Study (PIPAC EstoK 01)

December 7, 2022 updated by: Assistance Publique - Hôpitaux de Paris

Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) in Gastric Carcinomatosis. Phase II Randomized Study - PIPAC EstoK 01

Peritoneal metastasis is a common pattern in advanced gastric cancer leading to a terminal condition in a very short time. Whatever recent progress regarding systemic chemotherapy using multi drugs association median survival is limited to 6 months with altered quality of life (QoL) after 4 months for all patients. We postulated that a new innovative health technology for delivering intraperitoneal pressurized aerosol of chemotherapy (Doxorubicin and Cisplatin) during laparoscopy can transform that situation offering to double the survival with QoL preservation. Interestingly, PIPAC procedure is made to be applied repeatedly, every 4 to 6 weeks. This therapeutic strategy allows to improved Intra Peritoneal (IP) drugs impregnation and maintained Intra-Veinous (IV) chemotherapy meanwhile. The primary objective of this study is to evaluate and compare 24-month progression free-survival in patients with peritoneal carcinomatosis of gastric cancer treated either with IV chemotherapy and Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) or with IV chemotherapy alone, with preservation of quality of life.

Study Overview

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Phase 2

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

      • Lille, France, 59000
        • Hôpital Universitaire Claude Huriez

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

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 < age ≤ 75 years
  • Performance status (WHO) < 2
  • White blood cells > 3.500 /mm3; neutrophils > 1.500 /mm3; platelets > 100.000 /mm3
  • Creatinemia < 1.5 x Normal, Normal ASAT, ALAT and Serum total bilirubin, Normal ionic balance (potassium, calcium, magnesium and phosphorus
  • An acceptable nutritional condition with Body Mass Index (BMI) > 18.5 kg/m2, Albumin > 30 g/l, pre-albumin > 110 mg/l
  • Effective contraception for patients of childbearing age
  • Written consent obtained prior any act of the research
  • Patient with social insurance
  • Patient having synchronous or metachronous peritoneal metastasis or ovarian metastasis of a gastric adenocarcinoma cancer, including adenocarcinoma with independent cells (ADCI) or linitis
  • Patients with or without primary gastric tumor could be included
  • Peritoneal Cancer Index (PCI) > 8

Exclusion Criteria:

  • Weight loss > 20% of total body weight before disease
  • Presence of uncontrolled comorbidities including severe chronic disease or organ insufficiency
  • Contraindication to any drug contained in the chemotherapy regimen, according to summary of product characteristic's
  • Having any form of previous intra-abdominal chemotherapy or intra-abdominal antibody therapy
  • Patients with history of allergic reactions to platinum compounds or doxorubicin
  • Complete deficiency of the enzyme dihydropyrimidine dehydrogenase.
  • Patients are not allowed to undergo any cancer-specific treatment during the trial.
  • Secondary debulking surgery is not allowed during PIPAC treatment
  • Pregnancy or breastfeeding
  • Patient under guardianship
  • Other systemic metastases (liver, lung, bone, brain) or lombo-aortic lymph node involvement
  • Pleural effusion requiring evacuation for respiratory failure
  • Small bowel occlusion with no possible food intake
  • Ascites > 3 liters
  • HER2 +++ tumor

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control Arm
Patient will receive standard poly chemotherapy proposed by the oncologist or any new standard validated during the study, until progression or toxicity.
Experimental: Experimental Arm : PIPAC
After insufflation of a 12 mmHg of capnoperitoneum at 37°C, two balloons safety trocars (10 and 12mm) are inserted into the abdominal wall. Injection of Doxorubicin (2.1 mg/m2 in 50 ml NaCl 0.9%) and Cisplatin (10.5 mg/m2 body surface in 150 ml NaCl 0.9%) with a flow rate of 0.7ml/s, the therapeutic capnoperitoneum is maintained for 30 min at body temperature.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free survival
Time Frame: 24 months
24-month progression free-survival, defined as time from randomization to any clinical (ascites, abdominal pain, weight loss > 10% of total body weight) and/or morphological signs (systemic metastases, ascites, progression with RECIST criteria) of recurrence (local or systemic) or death.
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pain H6
Time Frame: 6 hours after end of surgery
Postoperative pain with a numeric rating scale from 0 to 10 (0 being no pain and 10 the worst possible pain)
6 hours after end of surgery
Postoperative pain H12
Time Frame: 12 hours after end of surgery
Postoperative pain with a numeric rating scale from 0 to 10 (0 being no pain and 10 the worst possible pain)
12 hours after end of surgery
Postoperative pain H18
Time Frame: 18 hours after end of surgery
Postoperative pain with a numeric rating scale from 0 to 10 (0 being no pain and 10 the worst possible pain)
18 hours after end of surgery
Postoperative pain H24
Time Frame: 24 hours after end of surgery
Postoperative pain with a numeric rating scale from 0 to 10 (0 being no pain and 10 the worst possible pain)
24 hours after end of surgery
Postoperative pain H30
Time Frame: 30 hours after end of surgery
Postoperative pain with a numeric rating scale from 0 to 10 (0 being no pain and 10 the worst possible pain)
30 hours after end of surgery
Postoperative pain H36
Time Frame: 36 hours after end of surgery
Postoperative pain with a numeric rating scale from 0 to 10 (0 being no pain and 10 the worst possible pain)
36 hours after end of surgery
Postoperative pain H42
Time Frame: 42 hours after end of surgery
Postoperative pain with a numeric rating scale from 0 to 10 (0 being no pain and 10 the worst possible pain)
42 hours after end of surgery
Postoperative pain H48
Time Frame: 48 hours after end of surgery
Postoperative pain with a numeric rating scale from 0 to 10 (0 being no pain and 10 the worst possible pain)
48 hours after end of surgery
Overall survival
Time Frame: 24 months
Progression Free survival
24 months
Secondary resectability rate
Time Frame: 24 months
Secondary resectability rate after the treatment
24 months
Quality of life
Time Frame: monthly until death or 24 months
Quality of life evaluated monthly by the patient with the EORTC QLQ-STO22 questionnaire
monthly until death or 24 months
Quality of health status
Time Frame: monthly until death or 24 months
Quality of health status evaluated monthly by the patient with the EQ-5D-5L questionnaire
monthly until death or 24 months
Toxicity
Time Frame: 60 days
Rate of treatment-related toxicity at 60 days of each PIPAC procedure
60 days
PIPAC success
Time Frame: 24 hours
Rate of successful PIPAC procedures
24 hours
Morbidity Clavien-Dindo
Time Frame: 60 days
Morbidity will be evaluated on post-operative day 60 by the Clavien-Dindo classification (I to V)
60 days
Morbidity Complication Index
Time Frame: 60 days
Morbidity will be evaluated by the Comprehensive Complication Index, ranging from 0 to 100 (https://www.assessurgery.com/about_cci-calculator)
60 days
Discontinuation
Time Frame: 24 months
The time of discontinuation defined as the time from randomization to therapy change or dose reduction because of progression of disease or intolerance or adverse effects or patient refusal or death.
24 months

Collaborators and Investigators

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

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)

June 11, 2020

Primary Completion (Anticipated)

February 2, 2024

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

August 21, 2019

First Submitted That Met QC Criteria

August 21, 2019

First Posted (Actual)

August 22, 2019

Study Record Updates

Last Update Posted (Estimate)

December 9, 2022

Last Update Submitted That Met QC Criteria

December 7, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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