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

Phase 2

Suspended

• Conditions: Gastric Adenocarcinoma; Chemotherapy Effect; Cancer Metastatic
• Interventions: Drug: Standard chemotherapy; Drug: Pressurized intraperitoneal aerosol chemotherapy (PIPAC)

• Registration Number: NCT04065139
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-08-21
• Study First Submitted QC: 2019-08-21
• Study First Posted: 2019-08-22
• Study Start: 2020-06-11
• Status Verified: 2022-04
• Last Update Submitted: 2022-12-07
• Last Update Posted: 2022-12-09
• Primary Completion: 2024-02-02
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 66

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Arm	Standard chemotherapy	-
Experimental Arm : PIPAC	Pressurized intraperitoneal aerosol chemotherapy (PIPAC)	-

Primary Outcome Measures

Name	Time	Method
Progression Free survival	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

Name	Time	Method
Postoperative pain H12	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)
Toxicity	60 days	Rate of treatment-related toxicity at 60 days of each PIPAC procedure
Quality of life	monthly until death or 24 months	Quality of life evaluated monthly by the patient with the EORTC QLQ-STO22 questionnaire
PIPAC success	24 hours	Rate of successful PIPAC procedures
Morbidity Clavien-Dindo	60 days	Morbidity will be evaluated on post-operative day 60 by the Clavien-Dindo classification (I to V)
Postoperative pain H6	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 H18	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 H36	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	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	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	24 months	Progression Free survival
Quality of health status	monthly until death or 24 months	Quality of health status evaluated monthly by the patient with the EQ-5D-5L questionnaire
Discontinuation	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.
Postoperative pain H24	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	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)
Secondary resectability rate	24 months	Secondary resectability rate after the treatment
Morbidity Complication Index	60 days	Morbidity will be evaluated by the Comprehensive Complication Index, ranging from 0 to 100 (https://www.assessurgery.com/about_cci-calculator)

Trial Locations

Locations (1)

Hôpital Universitaire Claude Huriez; 🇫🇷 Lille, France