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Study of 5-Fluorouracil and Leucovorin and Intra-abdominal Floxuridine Chemoradiation in Patients With Fully Resected Locally Advanced Gastric Adenocarcinoma
NCT00183911 · View on ClinicalTrials.gov ↗
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00183911
The ClinicalTrials.gov registry entry for NCT00183911 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Southern California, which has 412 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00183911 reports 1 study location spanning 1 distinct geographic area — top geographies include California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00183911?
The interventions under investigation include: Surgery (PROCEDURE), floxuridine, 5-Fluorouracil, leucovorin (DRUG), External Beam Radiotherapy (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00183911?
This trial is sponsored by University of Southern California, which has 412 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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