Ignite Creation Date:
2024-05-05 @ 4:57 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00352755
Status:
TERMINATED
Last Update Posted:
2016-12-13
First Post:
2006-07-14
Brief Title:
A Phase II Study of Surgical Debulking With Peritonectomy and Biweekly Intraperitoneal 5FU With Systemic Oxaliplatin5FULeucovorin in Patients With Pseudomyxoma Peritonei or Peritoneal Carcinomatosis
Sponsor:
Washington University School of Medicine
Organization:
Washington University School of Medicine
Study Overview
Official Title:
A Phase II Study of Surgical Debulking With Peritonectomy and Biweekly Intraperitoneal 5FU With Systemic Oxaliplatin5FULeucovorin in Patients With Pseudomyxoma Peritonei or Peritoneal Carcinomatosis
Status:
TERMINATED
Status Verified Date:
2016-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
after interim analysis it was determined that the risks were too great in comparision to the results
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study prospectively evaluates a multidisciplinary approach to patients with intraperitoneal carcinomatosis at Washington University Patients with peritoneal carcinomatosis or pseudomyxoma peritonei will undergo debulking surgery with peritonectomy and placement of adhesive barrier film followed by repeated delayed intraperitoneal chemotherapy with 5FU with systemic oxaliplatin-based chemotherapy on a biweekly schedule A retrospective review of patients treated in a similar manner at our institution showed good tolerance and efficacy This formal Phase II study is planned to determine the safety toxicities and survival of patients with peritoneal carcinomatosis and pseudomyxoma peritonei treated with this regimen
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