Phase II multicenter randomized trial evaluating the association of PIPAC and systemic chemotherapy versus systemic chemotherapy alone as 1st-line treatment of Malignant Peritoneal Mesothelioma
- Conditions
- Patient with Histologically-confirmed diagnosis of peritoneal malignant mesothelioma and non eligible for cytoreductive surgeryTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2019-001515-23-FR
- Lead Sponsor
- Institut Régional du Cancer de Montpellier
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 66
1) Age = 18 years to < 75 years ;
2) ECOG Performance Status of 0 to 2;
3) Histologically-confirmed diagnosis of peritoneal malignant mesothelioma;
4) No previous treatment (both medical and surgical oncologic treatments) for peritoneal malignant mesothelioma except for exploratory laparoscopy or diverting stoma;
5) Peritoneal Carcinomatosis Index (PCI)>27 or at least 4 points on the small bowel with serosal involvement contraindicating the cytoreductive surgery because of the impossibility to preserve a length >=1.5 m of uninvolved small bowel;
6) Life expectancy of at least 6 months
7) Adequate bone marrow and hepatic function defined as:
a. Absolute neutrophil count (ANC) = 1.5 x 109 / L
b. Platelet count = 100 x 109 / L
c. Creatinine clearance = 60 ml/min
d. The total bilirubin = 1.5 times upper limit of normal
e. Alkaline phosphatase (AP), aspartate aminotransferase (AST or SGOT) and alanine aminotransferase (ALT or SGPT) = 3 times upper limit of normal. Alkaline phosphatase, AST and ALT = 5 times upper limit of normal is acceptable if liver has tumour involvement.
8) For women of reproductive potential, negative serum beta human chorionic gonadotropin (ß-HCG) pregnancy test obtained within 7 days before the start of study treatment.
9) Patients with reproductive potential and who are sexually active must agree to have at least one method of contraception for the duration of treatment and 6 months after the last administration of study treatment. The investigator or a designated associate is requested to advise the patient how to achieve an adequate birth control. Adequate contraception is defined in the study as any medically recommend method (or combination of methods) as per standard care.
10) Written and dated informed consent before any study procedure.
11) Affiliated to the French national social security system.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 66
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 66
1) Patients eligible for cytoreductive surgery
2) Extra abdominal metastatic disease except for limited extra-peritoneal disease (mediastinal and/or retroperitoneal lymph nodes, oligo-metastatic lung disease);
3) Subjects considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease such as:
- progressive active infection, uncontrolled infection
- symptomatic cardiac or coronary insufficiency,
- history of recent myocardial infarction,
- severe renal insufficiency, renal impairment, defined as GFR<60 mL/min per 1.73m2, calculated by the Modification of Diet in Renal Disease (MDRD) abbreviated formula, pre-existing hearing impairment,
- pre-existing cisplatin-induced neuropathy,
- or any other severe medical condition
4) Any contraindication to repeated laparoscopy (eg. Ventriculo-peritoneal shunt without valves, pulmonary hypertension);
5) Complete or partial bowel obstruction non responsive to medical treatment;
6) Known hypersensitivity to any of the study drugs, study drug classes, or any constituent of the products.
7) Known positive test for human immunodeficiency virus (HIV), hepatitis B or C virus.
8) Live attenuated vaccines are prohibited 10 days before and during the treatment
9) Other cancer treated within the last 2 years except in situ cervical carcinoma or basocellular carcinoma;
10) Removal of > 10 L of ascites per week;
11) Pregnant or breast-feeding woman;
12) Previously operated patients where laparoscopy is not feasible;
13) Participation in another clinical trial within 30 days prior to study entry
14) Anticancer therapy (e.g chemotherapy, targeted therapy, concomitant systemic immune therapy, or any experimental therapy) within 4 weeks before inclusion.
15) Any other condition or therapy that in the investigator’s opinion may pose a risk to the patient or interfere with the study objectives
16) Persons deprived of liberty or under guardianship or incapable of giving consent;
17) Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol or follow-up schedule.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Evaluate the overall survival;Secondary Objective: To evaluate the<br>- PFS<br>- Response to treatment<br>- Safety<br>- Compliance<br>- Conversion to resectability<br>- Quality of life<br>- Medico-economic;Primary end point(s): The overall survival;Timepoint(s) of evaluation of this end point: The time from the date of randomization to the date of death from any cause.
- Secondary Outcome Measures
Name Time Method