Skip to main content
OpenTrials
Completed

NCT Number: NCT04065139

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Gastric Adenocarcinoma Cancer Metastatic Chemotherapy Effect Neoplasm Metastasis Neoplasms Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hôpital Universitaire Claude Huriez

Lille, 59000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pressurized intraperitoneal aerosol chemotherapy (PIPAC)

Drug

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.

Standard Chemotherapy

Drug

Patient will receive standard poly chemotherapy proposed by the oncologist or any new standard validated during the study, until progression or toxicity.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: PIPAC EstoK 01

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Aug 22, 2019
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.