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NCT00525915 · ClinicalTrials.gov registry record · Phase 2
Oxaliplatin-Based Chemotherapy and Chemoradiotherapy or Chemoradiotherapy in Esophageal or Gastroesophageal Carcinoma
A Phase 2 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 126
- Enrollment target
NCT00525915: Completed Phase 2 study, sponsored by M.D. Anderson Cancer Center.
NCT00525915 is a Phase 2 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 126 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00525915, a Phase 2 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 126 participants
- Enrollment target
Study Summary
The goal of this clinical research study is to learn if a combination of the investigational drug oxaliplatin with 5-Fluorouracil (5-FU) (given at the same time as radiation therapy) is as effective as a combination of these two drugs given before and during radiation therapy in the treatment of esophageal or gastroesophageal cancers. The safety of these combinations of therapy will also be compared. Objectives: Primary objective: Compare the Pathologic Complete Response rate and % of patients with \<50% residual cancer in the resected surgical specimen between Arms A and B. Secondary objectives: 1. Compare 1-year and 3-year survival rates, median survival time, R0 resection rates, safety, and local plus systemic relapse rates between Arms A and B 2. Perform exploratory correlative studies on blood, adjacent normal and cancer tissue to assess predictive markers of response and outcome. 3. Evaluate the joint effects, including possible interactive effects, of proton-versus-photon therapy and treatment arm on overall survival, R0 resection rates, safety, and local plus systemic relapse rates.
Interventions
- DRUG Oxaliplatin
- RADIATION Radiation Therapy
- DRUG 5-Fluorouracil
- PROCEDURE Surgery
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 126 participants |
| Start Date | 2005-04 |
| Est. Completion | 2013-03 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00525915
The ClinicalTrials.gov registry entry for NCT00525915 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 126 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is M.D. Anderson Cancer Center, which has 2,692 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Oxaliplatin is the first listed.
NCT00525915 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00525915 about?
NCT00525915 is a clinical study titled "Oxaliplatin-Based Chemotherapy and Chemoradiotherapy or Chemoradiotherapy in Esophageal or Gastroesophageal Carcinoma". The goal of this clinical research study is to learn if a combination of the investigational drug oxaliplatin with 5-Fluorouracil (5-FU) (given at the same time as radiation therapy) is as effective as a combination of these two drugs given before and during radiation therapy in the treatment of eso...
What is the current status of trial NCT00525915?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 126 participants. The study started on 2005-04. Estimated completion is 2013-03.
What interventions are being tested in trial NCT00525915?
The interventions under investigation include: Oxaliplatin (DRUG), Radiation Therapy (RADIATION), 5-Fluorouracil (DRUG), Surgery (PROCEDURE).
Who is sponsoring clinical trial NCT00525915?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
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