Ignite Creation Date:
2024-05-06 @ 9:35 AM
Last Modification Date:
2024-10-26 @ 12:17 PM
Study NCT ID:
NCT03028155
Status:
UNKNOWN
Last Update Posted:
2017-01-23
First Post:
2016-12-24
Brief Title:
Concentration- Versus Body Surface Area-based HIPEC in Colorectal Peritoneal Carcinomatosis Treatment
Sponsor:
Hasselt University
Organization:
Hasselt University
Study Overview
Official Title:
Concentration-based Versus Body Surface Area-based Peroperative Intraperitoneal Chemotherapy HIPEC After Optimal Cytoreductive Surgery in Colorectal Peritoneal Carcinomatosis Treatment - Randomized Non-blinded Phase III Clinical Trial
Status:
UNKNOWN
Status Verified Date:
2017-01
Last Known Status:
RECRUITING
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:
COBOX
Brief Summary:
Colorectal Cancer CRC is the third most common cancer and the fourth most common cause of cancer-related death worldwide CRC frequently gives rise to transcoelomic spread of tumor cells in the peritoneal cavity which ultimately leads to Peritoneal Carcinomatosis PC A new loco-regional treatment modality combines Cytoreductive Surgery CRS and Hyperthermic Intraperitoneal Peroperative Chemotherapy HIPEC The current HIPEC dosing regimens for the treatment of colorectal PC can be divided into body surface area BSA-based protocols and concentration-based protocols Most groups currently use a drug dose based on calculated BSA mgm2 in analogy to systemic chemotherapy regimens These regimens take BSA as a measure for the effective contact area represented as the peritoneal surface in the formula for dose intensification However an imperfect correlation exists between actual peritoneal surface area and calculated BSA Sex differences but also altered pathophysiological characteristics or frequent complications in patients ascites are responsible for differences in peritoneal surface areas which in turn affect absorption characteristics This takes us away from the initial homogenous drug concentration desired increasing the variability in the systemic and tumor exposure to the drug Pharmacokinetic changes induced by the volume of chemotherapy solution with constant drug dose administered intraperitoneally have already been reported This resulted in less precise predictions of the toxicity associated with the treatment By contrast some groups use a totally different dosimetry regimen based on concentration From a pharmacologic point of view the big advantage of a concentration-based system is that the residual tumor nodules after CRS are exposed to a constant diffusional force and thus cytotoxicity Unfortunately the prize to be paid for a better prediction of the efficacy of the IP chemotherapy is a high unpredictability of the levels of plasmatic cancer chemotherapy and thus toxicity This randomised non-blinded phase III clinical trial will be the first trial to pharmacologically evaluate the two dosing regimens BSA-based and concentration-based both applied as standard of care in current practice
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None