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NCT00941655 · ClinicalTrials.gov registry record · Phase 3
Prospective Randomized Trial Comparing Gastrectomy, Metastasectomy Plus Systemic Therapy Versus Systemic Therapy Alone: GYMSSA Trial
A Phase 3 study of Gastric Cancer, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 3
- Development phase
- 15
- Enrollment target
- 1
- Study location
NCT00941655 is a Phase 3 study of Gastric Cancer that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 15 participants, below the 319-participant average among 153 other Gastric Cancer trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00941655, a Phase 3 study of Gastric Cancer, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 15 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: * Gastric (stomach) cancer is a rare cancer. In most cases, by the time it has been diagnosed it has spread to other organs in the body and the chance of a cure is very small. The standard treatment for gastric cancer is a combination of chemotherapy drugs. * Researchers are interested in finding out if surgically removing all tumors before beginning chemotherapy for stomach cancer can slow or halt its spread better than giving chemotherapy alone. Objectives: \- To determine whether tumor removal surgery followed by chemotherapy is more effective in treating gastric cancer than chemotherapy given alone. Eligibility: \- Patients 18 years of age and older who have been diagnosed with gastric cancer. Design: * All patients will undergo an initial physical examination, blood tests, imaging scans, and a laparoscopy to determine the extent of the disease. * Half of the participants will be assigned to have surgery first and then chemotherapy; the other half will be assigned to have chemotherapy alone. * The surgery-plus-chemotherapy group will have major surgery to remove all tumors in the stomach and abdominal area, followed by a recovery time of up to 4 weeks. Chemotherapy will begin 6 to 8 weeks after surgery. * The chemotherapy-only group will begin treatment within 2 weeks of laparoscopy. * All patients will receive four chemotherapy drugs: 5-Fluorouracil, leucovorin, oxaliplatin, and irinotecan. The drugs are given intravenously over 2 days every 2 weeks (one cycle) for 12 cycles (about 6 months), either at the National Institutes of Health (NIH) Clinical Center or at home with a referring oncologist. Patients in the surgery group who have tumors in the peritoneum will receive an additional set of chemotherapy drugs in a separate treatment. * During the chemotherapy cycles, patients will provide blood samples approximately once a week and will have physical examinations and scans on a regular basis. * Patients will return to the NIH Clinical
Conditions Studied
Interventions
- DRUG Leucovorin
- DRUG Oxaliplatin
- DRUG Irinotecan
- DRUG 5-Fluorouracil
- PROCEDURE Gastrectomy and/or metastasectomy
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2009-07-22 |
| Est. Completion | 2012-06-18 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00941655
The ClinicalTrials.gov registry entry for NCT00941655 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 319-participant average among 153 other Gastric Cancer trials with a reported enrollment target (95% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Gastric Cancer appearing as the primary indexed condition, and to 5 interventions - of which Leucovorin is the first listed.
NCT00941655 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT00941655 about?
NCT00941655 is a clinical study titled "Prospective Randomized Trial Comparing Gastrectomy, Metastasectomy Plus Systemic Therapy Versus Systemic Therapy Alone: GYMSSA Trial". Background: * Gastric (stomach) cancer is a rare cancer. In most cases, by the time it has been diagnosed it has spread to other organs in the body and the chance of a cure is very small. The standard treatment for gastric cancer is a combination of chemotherapy drugs. * Researchers are interested ...
What is the current status of trial NCT00941655?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 15 participants. The study started on 2009-07-22. Estimated completion is 2012-06-18.
What conditions does trial NCT00941655 study?
This clinical trial studies the following conditions: Gastric Cancer.
What interventions are being tested in trial NCT00941655?
The interventions under investigation include: Leucovorin (DRUG), Oxaliplatin (DRUG), Irinotecan (DRUG), 5-Fluorouracil (DRUG), Gastrectomy and/or metastasectomy (PROCEDURE).
Who is sponsoring clinical trial NCT00941655?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00941655 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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