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

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ClinicalTrials.gov Identifier: NCT04065139
Recruitment Status : Not yet recruiting
First Posted : August 22, 2019
Last Update Posted : August 22, 2019
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Tracking Information
First Submitted Date  ICMJE August 21, 2019
First Posted Date  ICMJE August 22, 2019
Last Update Posted Date August 22, 2019
Estimated Study Start Date  ICMJE September 10, 2019
Estimated Primary Completion Date September 10, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 21, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 21, 2019)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • Overall survival [ Time Frame: 24 months ]
    Progression Free survival
  • Secondary resectability rate [ Time Frame: 24 months ]
    Secondary resectability rate after the treatment
  • 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
  • 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
  • Toxicity [ Time Frame: 60 days ]
    Rate of treatment-related toxicity at 60 days of each PIPAC procedure
  • PIPAC success [ Time Frame: 24 hours ]
    Rate of successful PIPAC procedures
  • Morbidity Clavien-Dindo [ Time Frame: 60 days ]
    Morbidity will be evaluated on post-operative day 60 by the Clavien-Dindo classification (I to V)
  • 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)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) in Gastric Carcinomatosis. Phase II Randomized Study
Official Title  ICMJE Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) in Gastric Carcinomatosis. Phase II Randomized Study - PIPAC EstoK 01
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Gastric Adenocarcinoma
  • Cancer Metastatic
  • Chemotherapy Effect
Intervention  ICMJE
  • Drug: Pressurized intraperitoneal aerosol chemotherapy (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.
  • Drug: Standard chemotherapy
    Patient will receive standard poly chemotherapy proposed by the oncologist or any new standard validated during the study, until progression or toxicity.
Study Arms  ICMJE
  • Active Comparator: Control Arm
    Intervention: Drug: Standard chemotherapy
  • Experimental: Experimental Arm : PIPAC
    Intervention: Drug: Pressurized intraperitoneal aerosol chemotherapy (PIPAC)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: August 21, 2019)
94
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 10, 2022
Estimated Primary Completion Date September 10, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Clarisse Eveno, MD, PhD 320444407 ext +33 clarisse.eveno@gmail.com
Contact: Matthieu RESCHE-RIGON, MD PhD 142499742 ext +33 matthieu.resche-rigon@univ-paris-diderot.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04065139
Other Study ID Numbers  ICMJE P160951J
2018-004755-20 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor  ICMJE Assistance Publique - Hôpitaux de Paris
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP