- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04065139
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
Status
Suspended
Intervention / Treatment
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
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-
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Lille, France, 59000
- Hôpital Universitaire Claude Huriez
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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
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Patient will receive standard poly chemotherapy proposed by the oncologist or any new standard validated during the study, until progression or toxicity.
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Experimental: Experimental Arm : PIPAC
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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)
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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
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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
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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)
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36 hours after end of surgery
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Postoperative pain H42
Time Frame: 42 hours after end of surgery
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Postoperative pain with a numeric rating scale from 0 to 10 (0 being no pain and 10 the worst possible pain)
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42 hours after end of surgery
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Postoperative pain H48
Time Frame: 48 hours after end of surgery
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Postoperative pain with a numeric rating scale from 0 to 10 (0 being no pain and 10 the worst possible pain)
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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
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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
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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
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24 hours
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Morbidity Clavien-Dindo
Time Frame: 60 days
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Morbidity will be evaluated on post-operative day 60 by the Clavien-Dindo classification (I to V)
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60 days
|
Morbidity Complication Index
Time Frame: 60 days
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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
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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
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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
Additional Relevant MeSH Terms
Other Study ID Numbers
- P160951J
- 2018-004755-20 (EudraCT Number)
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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