Ignite Creation Date:
2024-05-06 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 1:55 PM
Study NCT ID:
NCT04734691
Status:
NOT_YET_RECRUITING
Last Update Posted:
2021-02-02
First Post:
2021-01-27
Brief Title:
Second Line Oxaliplatin Based Chemotherapy Alone Versus Oxaliplatin Based PIPAC and Chemotherapy in Colorectal Peritoneal Carcinomatosis A Phase II Randomize Mutli-centric Study
Sponsor:
Sleiman Marwan-Julien
Organization:
University Hospital Geneva
Study Overview
Official Title:
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:
NOT_YET_RECRUITING
Status Verified Date:
2021-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OPAC
Brief Summary:
Colorectal cancer is the third most common cancer in men and second in women It represent 345346 new cases per year in Europe and 134349 in the United States of America The peritoneal cavity is the second most frequent site after liver for colorectal cancer relapsePeritoneal 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 163 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
Currently systemic chemotherapy is the standard of care for the treatment of unresectable peritoneal carcinomatosis from colorectal cancer with a median survival rate of 163 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None