Status:
UNKNOWN
Second Line Oxaliplatin Based Chemotherapy Alone Versus Oxaliplatin Based PIPAC and Chemotherapy in Colorectal Peritoneal Carcinomatosis : A Phase II Randomize Mutli-centric Study
Lead Sponsor:
Sleiman Marwan-Julien
Conditions:
Peritoneal Carcinomatosis
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 th...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2024
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04734691
Start Date
October 1 2021
End Date
November 1 2024
Last Update
February 2 2021
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