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

NCT04734691 | Unknown Phase 2 DMC

• 1 other identifier: OPAC study
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Progression free survival

  any clinical sign and/or morphological sign of peritoneal recurrence or death

  8 months

Secondary Outcomes (1)

• Quality of life C30

  8 months

Study Arms (2)

Experimental Arm

EXPERIMENTAL

Procedure: PIPAC

Control Arm

ACTIVE COMPARATOR

Procedure: PIPAC

Interventions

PIPAC PROCEDURE

PIPAC is a laparoscopic procedure for intraperitoneal administration of chemotherapy

Control Arm; Experimental Arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sleiman Marwan-Julien: lead

MeSH Terms

Conditions

Peritoneal Neoplasms

Condition Hierarchy (Ancestors)

Abdominal Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Peritoneal Diseases

Central Study Contacts

Marwan-Julien Sleiman

CONTACT

0041795533197; marwan.sleiman@hcuge.ch

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: January 27, 2021
• First Posted: February 2, 2021
• Study Start: October 1, 2021
• Primary Completion: October 1, 2024
• Study Completion: November 1, 2024
• Last Updated: February 2, 2021

Record last verified: 2021-01