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NCT00268437 · ClinicalTrials.gov registry record · Phase 2
Radiation Therapy, Pemetrexed Disodium, and Carboplatin in Treating Patients With Locally Advanced Esophageal Cancer That Can Be Removed By Surgery
A Phase 2 study, sponsored by Alliance for Clinical Trials in Oncology.
- Terminated
- Registry status
- Phase 2
- Development phase
- 27
- Enrollment target
NCT00268437: Clinical Trial Phase 2 study, sponsored by Alliance for Clinical Trials in Oncology.
NCT00268437 is a Phase 2 study that was terminated before completion, run by Alliance for Clinical Trials in Oncology. The registered enrollment target is 27 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00268437, a Phase 2 study, was terminated before completion, sponsored by Alliance for Clinical Trials in Oncology.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 27 participants
- Enrollment target
Study Summary
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as pemetrexed disodium and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Pemetrexed disodium may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving radiation therapy together with pemetrexed disodium and carboplatin before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. PURPOSE: This phase II trial is studying how well giving radiation therapy together with pemetrexed disodium and carboplatin works in treating patients with locally advanced esophageal cancer that can be removed by surgery.
Primary Outcome
The proportion of pathologic complete responses will be estimated by the number of pathologic complete responses divided by the total number of evaluable patients. Ninety-five percent confidence intervals for the true pathologic complete response rate will be calculated. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for Measurable disease is defined as at least one lesion whose longest diameter can be accurately measured as ≥2.0 cm with conventional techniques or as ≥1.
Interventions
- DRUG Pemetrexed
- DRUG carboplatin
- PROCEDURE conventional surgery
- RADIATION radiation therapy
- PROCEDURE neoadjuvant therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2006-04 |
| Est. Completion | 2015-03 |
| Phase | Phase 2 |
Why NCT00268437 stopped before completion
NCT00268437 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 5 interventions - of which Pemetrexed is the first listed.
NCT00268437 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00268437 about?
NCT00268437 is a clinical study titled "Radiation Therapy, Pemetrexed Disodium, and Carboplatin in Treating Patients With Locally Advanced Esophageal Cancer That Can Be Removed By Surgery". RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as pemetrexed disodium and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Pemetrexed disodium may also sto...
What is the current status of trial NCT00268437?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 27 participants. The study started on 2006-04. Estimated completion is 2015-03.
What interventions are being tested in trial NCT00268437?
The interventions under investigation include: Pemetrexed (DRUG), carboplatin (DRUG), conventional surgery (PROCEDURE), radiation therapy (RADIATION), neoadjuvant therapy (PROCEDURE).
Who is sponsoring clinical trial NCT00268437?
This trial is sponsored by Alliance for Clinical Trials in Oncology, which has 446 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00268437's enrollment target sits among peer trials
27 1697th of 2000 higher than 293 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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