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NCT00864032 · ClinicalTrials.gov registry record · Phase 1
Trial of Neoadjuvant Conformal Radiotherapy Plus Sorafenib for Patients With Soft Tissue Sarcoma of the Extremity and Body Wall
A Phase 1 study, sponsored by University of California, Davis.
- Completed
- Registry status
- Phase 1
- Development phase
- 8
- Enrollment target
NCT00864032 is a Phase 1 study that has completed, run by University of California, Davis. The registered enrollment target is 8 participants.
The verdict
NCT00864032, a Phase 1 study, has completed, sponsored by University of California, Davis.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 8 participants
- Enrollment target
Study Summary
Patients will receive neoadjuvant sorafenib (investigational agent) in combination with preoperative external beam conformal radiotherapy (50 Gy in 25 fractions) for localized, large soft tissue sarcomas of the extremity and body wall prior to resection with curative intent. Sorafenib is an FDA-approved targeted agent for patients with renal cell carcinoma and hepatocellular carcinoma. Preliminary data suggest activity for sorafenib against soft tissue sarcoma in the metastatic setting. Limited data are available regarding the safety and efficacy of sorafenib in combination with radiotherapy. The Phase I portion of the trial will seek to establish the safety of sorafenib and radiotherapy in the neoadjuvant setting for soft tissue sarcomas of the extremity and body wall. The Phase II portion of the trial will aim to determine the pathologic near-complete/complete response rate (≥ 95% tumor necrosis) of this multimodality therapy. Molecular and dynamic contrast-enhanced MRI studies will seek to establish correlative biological and imaging markers of response and/or resistance to this therapy.
Interventions
- DRUG Sorafenib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2009-03 |
| Est. Completion | 2011-08 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00864032
The ClinicalTrials.gov registry entry for NCT00864032 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, Davis, which has 657 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Sorafenib is the first listed.
NCT00864032 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00864032 about?
NCT00864032 is a clinical study titled "Trial of Neoadjuvant Conformal Radiotherapy Plus Sorafenib for Patients With Soft Tissue Sarcoma of the Extremity and Body Wall". Patients will receive neoadjuvant sorafenib (investigational agent) in combination with preoperative external beam conformal radiotherapy (50 Gy in 25 fractions) for localized, large soft tissue sarcomas of the extremity and body wall prior to resection with curative intent. Sorafenib is an FDA-appr...
What is the current status of trial NCT00864032?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2009-03. Estimated completion is 2011-08.
What interventions are being tested in trial NCT00864032?
The interventions under investigation include: Sorafenib (DRUG).
Who is sponsoring clinical trial NCT00864032?
This trial is sponsored by University of California, Davis, which has 657 total clinical trials registered on ClinicalTrials.gov.
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