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

Gastric Adenocarcinoma Clinical Trial

— PIPAC EstoK 01  

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04065139
• Other study ID #: P160951J
• Secondary ID: 2018-004755-20
• Status: Suspended
• Phase: Phase 2
• Start date: June 11, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2022
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 66
• Est. completion date: December 31, 2024
• Est. primary completion date: February 2, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Cancer Metastatic
• Carcinoma
• Chemotherapy Effect
• Gastric Adenocarcinoma

Intervention

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

Locations

Country	Name	City	State
France	Hôpital Universitaire Claude Huriez	Lille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

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