Ignite Creation Date:
2024-05-06 @ 3:50 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04779554
Status:
RECRUITING
Last Update Posted:
2024-05-09
First Post:
2021-02-27
Brief Title:
Flat Dose Vs Weight-based IP Chemotherapy for CRSHIPEC
Sponsor:
Prakash Pandalai
Organization:
University of Kentucky
Study Overview
Official Title:
A Randomized Phase 2 Trial of Flat Dose Vs Weight-based Dose of Intra-peritoneal IP Chemotherapy for Patients Undergoing Cytoreductive Surgery and Heated Intra-peritoneal Chemotherapy CRSHIPEC for Advanced Gastrointestinal Malignancy
Status:
RECRUITING
Status Verified Date:
2024-05
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:
None
Brief Summary:
Peritoneal carcinomatosis from advanced gastro-intestinal malignancy has historically been associated with poor overall survival 12 months with few treatment options Cytoreductive surgery CRS which involves removal of all macroscopic tumor nodules combined with direct administration of heated intra-peritoneal IP chemotherapy HIPEC to the affected peritoneal surfaces has been shown to be an effective treatment option that extends overall survival among certain cases of peritoneal carcinomatosis IP chemotherapy allows delivery of a high dose of cytostatic drug directly onto the peritoneal surfaces at risk for microscopic residual disease while systemic exposure remains limited Additionally hyperthermia is known to enhance the cytotoxicity of several agents including Mitomycin C and improves the depth of peritoneal penetration
This trial will be a randomized phase 2 comparison of flat dose versus weight-based dose Mitomycin C The hypothesis of this study is that HIPEC weight-based dosing may result in similarly effective peritoneal Mitomycin C concentrations with less systemic absorption and potential systemic toxicity compared with the HIPEC flat dosing approach in patients undergoing CRSHIPEC
This trial will be a randomized phase 2 comparison of flat dose versus weight-based dose Mitomycin C The hypothesis of this study is that HIPEC weight-based dosing may result in similarly effective peritoneal Mitomycin C concentrations with less systemic absorption and potential systemic toxicity compared with the HIPEC flat dosing approach in patients undergoing CRSHIPEC
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None