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

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

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04734691
Acronym
OPAC
Enrollment
50
Registered
2021-02-02
Start date
2021-10-31
Completion date
2024-11-30
Last updated
2021-02-02

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

Conditions

Peritoneal Carcinomatosis

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

Interventions

PROCEDUREPIPAC

PIPAC is a laparoscopic procedure for intraperitoneal administration of chemotherapy

Sponsors

Sleiman Marwan-Julien
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Progression free survival8 monthsany clinical sign and/or morphological sign of peritoneal recurrence or death

Secondary

MeasureTime frame
Quality of life C308 months

Contacts

Primary ContactMarwan-Julien Sleiman
marwan.sleiman@hcuge.ch0041795533197

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026