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NCT00387868 · ClinicalTrials.gov registry record · Phase 2
Preoperative Treatment of Patients With High Risk Thymoma
A Phase 2 study, sponsored by Valley Health System.
- Completed
- Registry status
- Phase 2
- Development phase
- 21
- Enrollment target
NCT00387868 is a Phase 2 study that has completed, run by Valley Health System. The registered enrollment target is 21 participants.
The verdict
NCT00387868, a Phase 2 study, has completed, sponsored by Valley Health System.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 21 participants
- Enrollment target
Study Summary
This is a phase II study for patients with thymoma or thymic carcinoma thought to be at significant risk for recurrence following surgical removal. This study involves the use of combined chemotherapy and radiation therapy prior to surgery, in hopes of increasing the chances of complete resection. The chemoradiotherapy protocol is one which has been used extensively for other diseases, and the side effects are therefore well-documented. Patients with thymomas thought to be at significant risk for recurrence (by x-ray and pathology criteria) will be allowed to participate, and will undergo combined chemotherapy with radiation to the chest followed by surgical removal of the tumor and postoperative chemotherapy. The main outcome measured will be the rate of pathological complete response (e.g. no active tumor in the resected specimen) to the preoperative treatment. Patients will receive postoperative treatment based on surgical and pathologic criteria.
Interventions
- PROCEDURE Surgical Resection
- DRUG cisplatin and etoposide
- RADIATION Concurrent Radiotherapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2006-10 |
| Est. Completion | 2014-11 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00387868
The ClinicalTrials.gov registry entry for NCT00387868 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Valley Health System, which has 8 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Surgical Resection is the first listed.
NCT00387868 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00387868 about?
NCT00387868 is a clinical study titled "Preoperative Treatment of Patients With High Risk Thymoma". This is a phase II study for patients with thymoma or thymic carcinoma thought to be at significant risk for recurrence following surgical removal. This study involves the use of combined chemotherapy and radiation therapy prior to surgery, in hopes of increasing the chances of complete resection. T...
What is the current status of trial NCT00387868?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 21 participants. The study started on 2006-10. Estimated completion is 2014-11.
What interventions are being tested in trial NCT00387868?
The interventions under investigation include: Surgical Resection (PROCEDURE), cisplatin and etoposide (DRUG), Concurrent Radiotherapy (RADIATION).
Who is sponsoring clinical trial NCT00387868?
This trial is sponsored by Valley Health System, which has 8 total clinical trials registered on ClinicalTrials.gov.
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