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

P-HIPEC CYTOREDUCTION PLUS HIPEC IN PATIENTS AFFECTED BY PERITONEAL CARCINOMATOSIS: A FEASIBILITY TRIAL - P-HIPEC

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-000823-24-IT

Enrollment

Registered

2021-06-08

Start date

2017-02-14

Completion date

Unknown

Last updated

2024-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

peritoneal carcinomatosis MedDRA version: 20.0 Level: LLT Classification code 10026442 Term: Malignant neoplasm of retroperitoneum and peritoneum System Organ Class: 100000004864 MedDRA version: 20.0 Level: LLT Classification code 10039867 Term: Secondary malignant neoplasm of retroperitoneum and peritoneum System Organ Class: 100000004864

Interventions

Trade Name: MITOMYCIN C - 10 MG POLVERE PER SOLUZIONE INIETTABILE1 FLACONE Product Name: Mitomicina Product Code: mittomicina Pharmaceutical Form: Powder for solution for injection INN or Proposed INN

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: peritoneal cancer index (PCI) >20; intraperitoneal unresectable disease; extraperiotneal disease; poor cardiac function (EF 1.5 time threshold or creatinin clearence1.5 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).

Design outcomes

Primary

Measure	Time frame
Main Objective: evaluate the feasibility of surgical cytoreduction associated to hypertemic intraperitoneal chemotherapy (HIPEC) in patients with peritoneal carcinomatosis;Secondary Objective: evaluete the overall and disease free 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 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	—

Measure

Time frame

Main Objective: evaluate the feasibility of surgical cytoreduction associated to hypertemic intraperitoneal chemotherapy (HIPEC) in patients with peritoneal carcinomatosis;Secondary Objective: evaluete the overall and disease free 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 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

Measure	Time frame
Secondary end point(s): major postoperative complications < 30%; perioperative mortality (within 30 days 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	—

Countries

Italy

Contacts

Public ContactSC CHIRURGIA 1

AOU POLICLINICO DI MODENA

chir1@unimore.it0594223662

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026