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NCT00525785 · ClinicalTrials.gov registry record · Phase 2
Preoperative Chemo and Chemoradiotherapy for Adenocarcinoma of the Stomach and Gastroesophageal Junction (GEJ)
A Phase 2 study of Gastric Cancer and Stomach Cancer, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 58
- Enrollment target
- 1
- Study location
NCT00525785: Completed Phase 2 study of Gastric Cancer and Stomach Cancer, sponsored by M.D. Anderson Cancer Center.
NCT00525785 is a Phase 2 study of Gastric Cancer and Stomach Cancer that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 58 participants, below the 319-participant average among 153 other Gastric Cancer trials with a reported enrollment target (82% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00525785, a Phase 2 study of Gastric Cancer and Stomach Cancer, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 58 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this clinical research study is to learn if a combination of 5-FU, Folinic Acid and Oxaliplatin, given with radiation therapy, is effective in the treatment of gastric or gastroesophageal cancers that will be removed by surgery if possible. The safety of this combination therapy will also be studied.
Primary Outcome
The complete pathologic response (path CR) rate after treatment calculated as the percentage of participants with path CR out of the total participants, where the path CR is defined as absence of tumor cells in the surgical specimen and all registered participants are used in the denominator for calculating the path CR rate. Primary gastric carcinoma is not measurable by conventional criteria thus usual response criteria cannot be applied. The following criteria for response assessment applied:
Conditions Studied
Interventions
- DRUG Oxaliplatin
- RADIATION Radiotherapy
- DRUG 5-Fluorouracil
- PROCEDURE Surgery
- DRUG Folinic Acid
Study Locations (1)
Texas
- University of Texas MD Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 58 participants |
| Start Date | 2004-01 |
| Est. Completion | 2016-01 |
| Phase | Phase 2 |
What the finished NCT00525785 record still lists
NCT00525785 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 58 participants, a relatively small participant target, below the 319-participant average among 153 other Gastric Cancer trials with a reported enrollment target (82% lower).
The record links to 2 conditions, with Gastric Cancer appearing as the primary indexed condition, and to 5 interventions - of which Oxaliplatin is the first listed.
NCT00525785 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT00525785 about?
NCT00525785 is a clinical study titled "Preoperative Chemo and Chemoradiotherapy for Adenocarcinoma of the Stomach and Gastroesophageal Junction (GEJ)". The goal of this clinical research study is to learn if a combination of 5-FU, Folinic Acid and Oxaliplatin, given with radiation therapy, is effective in the treatment of gastric or gastroesophageal cancers that will be removed by surgery if possible. The safety of this combination therapy will als...
What is the current status of trial NCT00525785?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 58 participants. The study started on 2004-01. Estimated completion is 2016-01.
What conditions does trial NCT00525785 study?
This clinical trial studies the following conditions: Gastric Cancer, Stomach Cancer.
What interventions are being tested in trial NCT00525785?
The interventions under investigation include: Oxaliplatin (DRUG), Radiotherapy (RADIATION), 5-Fluorouracil (DRUG), Surgery (PROCEDURE), Folinic Acid (DRUG).
Who is sponsoring clinical trial NCT00525785?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00525785 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00525785's enrollment target sits among peer trials
58 112th of 153 higher than 41 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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