PERITONEAL NEOPLASTIC DISEASE TREATMENT BY SURGERY ANDINTRA-ABDOMINAL INFUSION OF CHEMOTHERAPIC DRUGS

Phase 1

• Conditions: peritoneal carcinomatosis; MedDRA version: 20.0Level: LLTClassification code 10026442Term: Malignant neoplasm of retroperitoneum and peritoneumSystem Organ Class: 100000004864; MedDRA version: 20.0Level: LLTClassification code 10039867Term: Secondary malignant neoplasm of retroperitoneum and peritoneumSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2016-000823-24-IT
• Lead Sponsor: AZIENDA OSPEDALIERO-UNIVERSITARIA DI MODENA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-08
• Last Update Posted: 17 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

patients affected by peritoneal carcinomatosis by gastric, colon and ovarian cancer, pseudomixoma periotnei, peritoneal mesotelioma between 18 and 75 years old
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 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

peritoneal cancer index (PCI) >20;
intraperitoneal unresectable disease;
extraperiotneal disease;
poor cardiac function (EF < 40%);
poor renal function (creatinin > 1.5 time threshold or creatinin clearence< 60mL/min);
poor epatic function (AST, ALT, Bilirubin >1.5 threshold);
poor bone marrow function (WBC <4000mm3 or PMN <1500/mm3 or PLT <80000/mm3);
poor pulmonary function (BCPO or rescrictive deficiency with FEV1 <50%, DLCO <40% of normal value adjusted for age).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: evaluate the feasibility of surgical cytoreduction<br>associated to hypertemic intraperitoneal chemotherapy (HIPEC) in patients with peritoneal carcinomatosis;Secondary Objective: evaluete the overall and disease free<br>survival at 1, 3 and 5 years; evaluation of post-operative ccomplication rate and perioperative death;Primary end point(s): feasibility of 80%: optimal cytoreduction<br>with disease residue inferior to 2.5 mm (CCR0-1) and permorming HIPEC at the end of surgical procedure;Timepoint(s) of evaluation of this end point: 24 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): major postoperative complications < 30%; perioperative mortality (within 30 days<br>after treatment); Median survival in the overall treatment 1,3,5 years and stratified by disease; disease-free survival at 1,3,5 years after treatment;Timepoint(s) of evaluation of this end point: 30 days; 30 days; 1,3,5 years from treatment; 1,3,5 years from treatment