Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00183911
Status:
COMPLETED
Last Update Posted:
2014-05-22
First Post:
2005-09-09
Brief Title:
Study of 5-Fluorouracil and Leucovorin and Intra-abdominal Floxuridine Chemoradiation in Patients With Fully Resected Locally Advanced Gastric Adenocarcinoma
Sponsor:
University of Southern California
Organization:
University of Southern California
Study Overview
Official Title:
Phase II Study of Adjuvant Intraperitoneal FUDR Treatment Added to Chemoradiation 5-FluorouracilLeucovorin Plus Total Dose 4500 cGy of External Beam Radiotherapy in Patients With Fully Resected Locally Advanced Gastric Adenocarcinoma
Status:
COMPLETED
Status Verified Date:
2014-05
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:
The purpose of this study is to evaluate the side effects of a new treatment for stomach cancer which may potentially improve the prognosis of this cancer
Our principle objective is to improve the results of standard chemotherapy and radiation after surgery of patients with gastric cancer The intra-abdominal intraperitoneal administration of floxuridine FUDR is a procedure that we have studied and have determined it is a safe treatment In this study we want to evaluate the side effects of this treatment when it is given after surgery but before standard intravenous chemotherapy and radiation
Study treatment will start with surgical removal of the part of the stomach with cancer together with surrounding tissues and lymph nodes After surgery patients will get treatment with a chemotherapy drug FUDR administered directly into the abdomen This is called intraperitoneal chemotherapy After this treatment patients will receive repeated intravenous injection of two drugs 5-fluorouracil and leucovorin alone or combined with irradiation of the abdomen
Our principle objective is to improve the results of standard chemotherapy and radiation after surgery of patients with gastric cancer The intra-abdominal intraperitoneal administration of floxuridine FUDR is a procedure that we have studied and have determined it is a safe treatment In this study we want to evaluate the side effects of this treatment when it is given after surgery but before standard intravenous chemotherapy and radiation
Study treatment will start with surgical removal of the part of the stomach with cancer together with surrounding tissues and lymph nodes After surgery patients will get treatment with a chemotherapy drug FUDR administered directly into the abdomen This is called intraperitoneal chemotherapy After this treatment patients will receive repeated intravenous injection of two drugs 5-fluorouracil and leucovorin alone or combined with irradiation of the abdomen
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