Clinical Trials /

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

NCT04065139

Description:

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.

Related Conditions:
  • Gastric Adenocarcinoma
Recruiting Status:

Not yet recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) in Gastric Carcinomatosis. Phase II Randomized Study
  • Official Title: Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) in Gastric Carcinomatosis. Phase II Randomized Study - PIPAC EstoK 01

Clinical Trial IDs

  • ORG STUDY ID: P160951J
  • SECONDARY ID: 2018-004755-20
  • NCT ID: NCT04065139

Conditions

  • Gastric Adenocarcinoma
  • Cancer Metastatic
  • Chemotherapy Effect

Interventions

DrugSynonymsArms
Pressurized intraperitoneal aerosol chemotherapy (PIPAC)Experimental Arm : PIPAC
Standard chemotherapyControl Arm

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Control ArmActive Comparator
  • Standard chemotherapy
Experimental Arm : PIPACExperimental
  • Pressurized intraperitoneal aerosol chemotherapy (PIPAC)

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
      
Maximum Eligible Age:75 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Progression Free survival
Time Frame:24 months
Safety Issue:
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.

Secondary Outcome Measures

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

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Assistance Publique - Hôpitaux de Paris

Trial Keywords

  • pressurized intraperitoneal aerosol chemotherapy (PIPAC)
  • gastric adenocarcinoma
  • metastasis

Last Updated