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NCT00183911 · ClinicalTrials.gov registry record · Phase 2
Study of 5-Fluorouracil and Leucovorin and Intra-abdominal Floxuridine Chemoradiation in Patients With Fully Resected Locally Advanced Gastric Adenocarcinoma
A Phase 2 study of Gastric Cancer and Gastric Adenocarcinoma, sponsored by University of Southern California.
- Completed
- Registry status
- Phase 2
- Development phase
- 25
- Enrollment target
- 1
- Study location
NCT00183911: Completed Phase 2 study of Gastric Cancer and Gastric Adenocarcinoma, sponsored by University of Southern California.
NCT00183911 is a Phase 2 study of Gastric Cancer and Gastric Adenocarcinoma that has completed, run by University of Southern California. The registered enrollment target is 25 participants, below the 319-participant average among 153 other Gastric Cancer trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00183911, a Phase 2 study of Gastric Cancer and Gastric Adenocarcinoma, has completed, sponsored by University of Southern California.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 25 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- PROCEDURE Surgery
- DRUG floxuridine, 5-Fluorouracil, leucovorin
- PROCEDURE External Beam Radiotherapy
Study Locations (1)
California
- U.S.C. / Norris Comprehensive Cancer Center - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2003-11 |
| Est. Completion | 2007-04 |
| Phase | Phase 2 |
What the finished NCT00183911 record still lists
NCT00183911 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 319-participant average among 153 other Gastric Cancer trials with a reported enrollment target (92% lower).
The record links to 2 conditions, with Gastric Cancer appearing as the primary indexed condition, and to 3 interventions - of which Surgery is the first listed.
NCT00183911 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT00183911 about?
NCT00183911 is a clinical study titled "Study of 5-Fluorouracil and Leucovorin and Intra-abdominal Floxuridine Chemoradiation in Patients With Fully Resected Locally Advanced Gastric Adenocarcinoma". 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 int...
What is the current status of trial NCT00183911?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 25 participants. The study started on 2003-11. Estimated completion is 2007-04.
What conditions does trial NCT00183911 study?
This clinical trial studies the following conditions: Gastric Cancer, Gastric Adenocarcinoma.
What interventions are being tested in trial NCT00183911?
The interventions under investigation include: Surgery (PROCEDURE), floxuridine, 5-Fluorouracil, leucovorin (DRUG), External Beam Radiotherapy (PROCEDURE).
Who is sponsoring clinical trial NCT00183911?
This trial is sponsored by University of Southern California, which has 617 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00183911 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00183911's enrollment target sits among peer trials
25 144th of 153 higher than 10 of 153 other Gastric Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Gastric Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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