Description:
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.
Title
- Brief Title: Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) in Gastric Carcinomatosis. Phase II Randomized Study
- Official Title: Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) in Gastric Carcinomatosis. Phase II Randomized Study - PIPAC EstoK 01
Clinical Trial IDs
- ORG STUDY ID:
P160951J
- SECONDARY ID:
2018-004755-20
- NCT ID:
NCT04065139
Conditions
- Gastric Adenocarcinoma
- Cancer Metastatic
- Chemotherapy Effect
Interventions
Drug | Synonyms | Arms |
---|
Pressurized intraperitoneal aerosol chemotherapy (PIPAC) | | Experimental Arm : PIPAC |
Standard chemotherapy | | Control Arm |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Control Arm | Active Comparator | | |
Experimental Arm : PIPAC | Experimental | | - Pressurized intraperitoneal aerosol chemotherapy (PIPAC)
|
Eligibility 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
Maximum Eligible Age: | 75 Years |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Progression Free survival |
Time Frame: | 24 months |
Safety Issue: | |
Description: | 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
Measure: | Postoperative pain H6 |
Time Frame: | 6 hours after end of surgery |
Safety Issue: | |
Description: | Postoperative pain with a numeric rating scale from 0 to 10 (0 being no pain and 10 the worst possible pain) |
Measure: | Postoperative pain H12 |
Time Frame: | 12 hours after end of surgery |
Safety Issue: | |
Description: | Postoperative pain with a numeric rating scale from 0 to 10 (0 being no pain and 10 the worst possible pain) |
Measure: | Postoperative pain H18 |
Time Frame: | 18 hours after end of surgery |
Safety Issue: | |
Description: | Postoperative pain with a numeric rating scale from 0 to 10 (0 being no pain and 10 the worst possible pain) |
Measure: | Postoperative pain H24 |
Time Frame: | 24 hours after end of surgery |
Safety Issue: | |
Description: | Postoperative pain with a numeric rating scale from 0 to 10 (0 being no pain and 10 the worst possible pain) |
Measure: | Postoperative pain H30 |
Time Frame: | 30 hours after end of surgery |
Safety Issue: | |
Description: | Postoperative pain with a numeric rating scale from 0 to 10 (0 being no pain and 10 the worst possible pain) |
Measure: | Postoperative pain H36 |
Time Frame: | 36 hours after end of surgery |
Safety Issue: | |
Description: | Postoperative pain with a numeric rating scale from 0 to 10 (0 being no pain and 10 the worst possible pain) |
Measure: | Postoperative pain H42 |
Time Frame: | 42 hours after end of surgery |
Safety Issue: | |
Description: | Postoperative pain with a numeric rating scale from 0 to 10 (0 being no pain and 10 the worst possible pain) |
Measure: | Postoperative pain H48 |
Time Frame: | 48 hours after end of surgery |
Safety Issue: | |
Description: | Postoperative pain with a numeric rating scale from 0 to 10 (0 being no pain and 10 the worst possible pain) |
Measure: | Overall survival |
Time Frame: | 24 months |
Safety Issue: | |
Description: | Progression Free survival |
Measure: | Secondary resectability rate |
Time Frame: | 24 months |
Safety Issue: | |
Description: | Secondary resectability rate after the treatment |
Measure: | Quality of life |
Time Frame: | monthly until death or 24 months |
Safety Issue: | |
Description: | Quality of life evaluated monthly by the patient with the EORTC QLQ-STO22 questionnaire |
Measure: | Quality of health status |
Time Frame: | monthly until death or 24 months |
Safety Issue: | |
Description: | Quality of health status evaluated monthly by the patient with the EQ-5D-5L questionnaire |
Measure: | Toxicity |
Time Frame: | 60 days |
Safety Issue: | |
Description: | Rate of treatment-related toxicity at 60 days of each PIPAC procedure |
Measure: | PIPAC success |
Time Frame: | 24 hours |
Safety Issue: | |
Description: | Rate of successful PIPAC procedures |
Measure: | Morbidity Clavien-Dindo |
Time Frame: | 60 days |
Safety Issue: | |
Description: | Morbidity will be evaluated on post-operative day 60 by the Clavien-Dindo classification (I to V) |
Measure: | Morbidity Complication Index |
Time Frame: | 60 days |
Safety Issue: | |
Description: | Morbidity will be evaluated by the Comprehensive Complication Index, ranging from 0 to 100 (https://www.assessurgery.com/about_cci-calculator) |
Measure: | Discontinuation |
Time Frame: | 24 months |
Safety Issue: | |
Description: | 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. |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Not yet recruiting |
Lead Sponsor: | Assistance Publique - Hôpitaux de Paris |
Trial Keywords
- pressurized intraperitoneal aerosol chemotherapy (PIPAC)
- gastric adenocarcinoma
- metastasis
Last Updated
August 22, 2019