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

Primary Purpose

Gastric Adenocarcinoma, Cancer Metastatic, Chemotherapy Effect

Status
Suspended
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Pressurized intraperitoneal aerosol chemotherapy (PIPAC)
Standard chemotherapy
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Adenocarcinoma focused on measuring pressurized intraperitoneal aerosol chemotherapy (PIPAC), gastric adenocarcinoma, metastasis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hôpital Universitaire Claude Huriez

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control Arm

Experimental Arm : PIPAC

Arm Description

Outcomes

Primary Outcome Measures

Progression Free survival
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.

Secondary Outcome Measures

Postoperative pain H6
Postoperative pain with a numeric rating scale from 0 to 10 (0 being no pain and 10 the worst possible pain)
Postoperative pain H12
Postoperative pain with a numeric rating scale from 0 to 10 (0 being no pain and 10 the worst possible pain)
Postoperative pain H18
Postoperative pain with a numeric rating scale from 0 to 10 (0 being no pain and 10 the worst possible pain)
Postoperative pain H24
Postoperative pain with a numeric rating scale from 0 to 10 (0 being no pain and 10 the worst possible pain)
Postoperative pain H30
Postoperative pain with a numeric rating scale from 0 to 10 (0 being no pain and 10 the worst possible pain)
Postoperative pain H36
Postoperative pain with a numeric rating scale from 0 to 10 (0 being no pain and 10 the worst possible pain)
Postoperative pain H42
Postoperative pain with a numeric rating scale from 0 to 10 (0 being no pain and 10 the worst possible pain)
Postoperative pain H48
Postoperative pain with a numeric rating scale from 0 to 10 (0 being no pain and 10 the worst possible pain)
Overall survival
Progression Free survival
Secondary resectability rate
Secondary resectability rate after the treatment
Quality of life
Quality of life evaluated monthly by the patient with the EORTC QLQ-STO22 questionnaire
Quality of health status
Quality of health status evaluated monthly by the patient with the EQ-5D-5L questionnaire
Toxicity
Rate of treatment-related toxicity at 60 days of each PIPAC procedure
PIPAC success
Rate of successful PIPAC procedures
Morbidity Clavien-Dindo
Morbidity will be evaluated on post-operative day 60 by the Clavien-Dindo classification (I to V)
Morbidity Complication Index
Morbidity will be evaluated by the Comprehensive Complication Index, ranging from 0 to 100 (https://www.assessurgery.com/about_cci-calculator)
Discontinuation
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.

Full Information

First Posted
August 21, 2019
Last Updated
December 7, 2022
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT04065139
Brief Title
Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) in Gastric Carcinomatosis. Phase II Randomized Study
Acronym
PIPAC EstoK 01
Official Title
Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) in Gastric Carcinomatosis. Phase II Randomized Study - PIPAC EstoK 01
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Suspended
Why Stopped
It was stopped following the recommendations of the trial Independent DSMB : Permanent discontinuation of inclusions (related to a suspected higher number of deaths in the experimental ARM)
Study Start Date
June 11, 2020 (Actual)
Primary Completion Date
February 2, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Adenocarcinoma, Cancer Metastatic, Chemotherapy Effect
Keywords
pressurized intraperitoneal aerosol chemotherapy (PIPAC), gastric adenocarcinoma, metastasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Arm
Arm Type
Active Comparator
Arm Title
Experimental Arm : PIPAC
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Pressurized intraperitoneal aerosol chemotherapy (PIPAC)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Standard chemotherapy
Intervention Description
Patient will receive standard poly chemotherapy proposed by the oncologist or any new standard validated during the study, until progression or toxicity.
Primary Outcome Measure Information:
Title
Progression Free survival
Description
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.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Postoperative pain H6
Description
Postoperative pain with a numeric rating scale from 0 to 10 (0 being no pain and 10 the worst possible pain)
Time Frame
6 hours after end of surgery
Title
Postoperative pain H12
Description
Postoperative pain with a numeric rating scale from 0 to 10 (0 being no pain and 10 the worst possible pain)
Time Frame
12 hours after end of surgery
Title
Postoperative pain H18
Description
Postoperative pain with a numeric rating scale from 0 to 10 (0 being no pain and 10 the worst possible pain)
Time Frame
18 hours after end of surgery
Title
Postoperative pain H24
Description
Postoperative pain with a numeric rating scale from 0 to 10 (0 being no pain and 10 the worst possible pain)
Time Frame
24 hours after end of surgery
Title
Postoperative pain H30
Description
Postoperative pain with a numeric rating scale from 0 to 10 (0 being no pain and 10 the worst possible pain)
Time Frame
30 hours after end of surgery
Title
Postoperative pain H36
Description
Postoperative pain with a numeric rating scale from 0 to 10 (0 being no pain and 10 the worst possible pain)
Time Frame
36 hours after end of surgery
Title
Postoperative pain H42
Description
Postoperative pain with a numeric rating scale from 0 to 10 (0 being no pain and 10 the worst possible pain)
Time Frame
42 hours after end of surgery
Title
Postoperative pain H48
Description
Postoperative pain with a numeric rating scale from 0 to 10 (0 being no pain and 10 the worst possible pain)
Time Frame
48 hours after end of surgery
Title
Overall survival
Description
Progression Free survival
Time Frame
24 months
Title
Secondary resectability rate
Description
Secondary resectability rate after the treatment
Time Frame
24 months
Title
Quality of life
Description
Quality of life evaluated monthly by the patient with the EORTC QLQ-STO22 questionnaire
Time Frame
monthly until death or 24 months
Title
Quality of health status
Description
Quality of health status evaluated monthly by the patient with the EQ-5D-5L questionnaire
Time Frame
monthly until death or 24 months
Title
Toxicity
Description
Rate of treatment-related toxicity at 60 days of each PIPAC procedure
Time Frame
60 days
Title
PIPAC success
Description
Rate of successful PIPAC procedures
Time Frame
24 hours
Title
Morbidity Clavien-Dindo
Description
Morbidity will be evaluated on post-operative day 60 by the Clavien-Dindo classification (I to V)
Time Frame
60 days
Title
Morbidity Complication Index
Description
Morbidity will be evaluated by the Comprehensive Complication Index, ranging from 0 to 100 (https://www.assessurgery.com/about_cci-calculator)
Time Frame
60 days
Title
Discontinuation
Description
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.
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Hôpital Universitaire Claude Huriez
City
Lille
ZIP/Postal Code
59000
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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