Second Line Oxaliplatin Based Chemotherapy Alone Versus Oxaliplatin Based PIPAC and Chemotherapy in Colorectal Peritoneal Carcinomatosis : A Phase II Randomize Mutli-centric Study

NCT ID: NCT04734691

Last Updated: 2021-02-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-31
• Study Completion Date: 2024-11-30

Brief Summary

Colorectal cancer is the third most common cancer in men and second in women. It represent 345'346 new cases per year in Europe and 134'349 in the United States of America. The peritoneal cavity is the second most frequent site, after liver, for colorectal cancer relapse.Peritoneal carcinomatosis (PC) is found in approximately 5 % of patients diagnosed with colorectal cancer and 24% of patients with synchronous metastasis at the time of diagnosis. Eight percent of colorectal cancer patient will develop PC during the course of their disease .

Currently systemic chemotherapy is the standard of care for the treatment of unresectable peritoneal carcinomatosis from colorectal cancer with a median survival rate of 16.3 months Peritoneal carcinomatosis has a poor response to systemic chemotherapy due to a weak penetration of agents into the peritoneum.

A new approach of intraperitoneal carcinomatosis is now developed: Pressurized intraperitoneal aerosol chemotherapy (PIPAC) is used to deliver intraperitoneal chemotherapy. It enhances the effect of chemotherapy because of the physical properties of aerosol and pressure.

PIPAC is a safe with a 23% morbidity and tolerated technic that is now well described.

We want to conduct a study to prove or infirm the superiority of PIPAC associated with systemic chemotherapy compare to systemic chemotherapy alone in peritoneal carcinomatosis from colorectal cancer

Conditions

Peritoneal Carcinomatosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Experimental Arm

Group Type: EXPERIMENTAL

PIPAC

Intervention Type: PROCEDURE

PIPAC is a laparoscopic procedure for intraperitoneal administration of chemotherapy

Control Arm

Group Type: ACTIVE_COMPARATOR

PIPAC

Intervention Type: PROCEDURE

PIPAC is a laparoscopic procedure for intraperitoneal administration of chemotherapy

Interventions

PIPAC

PIPAC is a laparoscopic procedure for intraperitoneal administration of chemotherapy

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patients 18 < age ≤ 75 years old with Performance status (WHO) ≤ 2 Histologically evidenced synchronous or metachronous PM of a colorectal cancer with a PCI ≥ 15 (No complete resectable PC) Histologically evidenced synchronous or metachronous PM of a colorectal cancer with a PCI < 15 + liver or pulmonary unresectable metastases PCI < 15 but with progression at the restaging after the first line of chemotherapy Unresectable peritoneal relapse secondary to cytoreduction surgery

Exclusion Criteria

• Patients with clinically significant ascites (> 3000 cc)
• Pleural effusion requiring evacuation for respiratory failure
• Small bowel occlusion with no possible food intake
• Presence of comorbidities, notably serious chronic diseases or organ failure

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sleiman Marwan-Julien

OTHER

Sponsor Role: lead

Responsible Party

Sleiman Marwan-Julien

Doctor

Responsibility Role: SPONSOR_INVESTIGATOR

Central Contacts

Marwan-Julien Sleiman

Role: CONTACT

marwan.sleiman@hcuge.ch

0041795533197

Other Identifiers

OPAC study

Identifier Type: -

Identifier Source: org_study_id