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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment Phase
Gastric Adenocarcinoma Cancer Metastatic Chemotherapy Effect Drug: Pressurized intraperitoneal aerosol chemotherapy (PIPAC) Drug: Standard chemotherapy Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 94 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) in Gastric Carcinomatosis. Phase II Randomized Study - PIPAC EstoK 01
Estimated Study Start Date : September 10, 2019
Estimated Primary Completion Date : September 10, 2022
Estimated Study Completion Date : September 10, 2022

Arm Intervention/treatment
Active Comparator: Control Arm 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.

Experimental: Experimental Arm : PIPAC 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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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)

  8. 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)

  9. Overall survival [ Time Frame: 24 months ]
    Progression Free survival

  10. Secondary resectability rate [ Time Frame: 24 months ]
    Secondary resectability rate after the treatment

  11. 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

  12. 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

  13. Toxicity [ Time Frame: 60 days ]
    Rate of treatment-related toxicity at 60 days of each PIPAC procedure

  14. PIPAC success [ Time Frame: 24 hours ]
    Rate of successful PIPAC procedures

  15. Morbidity Clavien-Dindo [ Time Frame: 60 days ]
    Morbidity will be evaluated on post-operative day 60 by the Clavien-Dindo classification (I to V)

  16. 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)

  17. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04065139


Contacts
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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

Locations
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France
Hôpital Universitaire Claude Huriez
Lille, France, 59000
Contact: Clarisse Eveno, MD    320444407 ext +33    clarisse.eveno@gmail.com   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT04065139    
Other Study ID Numbers: P160951J
2018-004755-20 ( EudraCT Number )
First Posted: August 22, 2019    Key Record Dates
Last Update Posted: August 22, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
pressurized intraperitoneal aerosol chemotherapy (PIPAC)
gastric adenocarcinoma
metastasis
Additional relevant MeSH terms:
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Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms