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NCT01446458 · ClinicalTrials.gov registry record · Phase 1
Phase I Study of Stereotactic Body Radiation Therapy and FOLFIRINOX in the Neoadjuvant Therapy of Pancreatic Cancer
A Phase 1 study, sponsored by Emory University.
- Completed
- Registry status
- Phase 1
- Development phase
- 13
- Enrollment target
NCT01446458 is a Phase 1 study that has completed, run by Emory University. The registered enrollment target is 13 participants.
The verdict
NCT01446458, a Phase 1 study, has completed, sponsored by Emory University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 13 participants
- Enrollment target
Study Summary
The purpose of this study is to determine whether using FOLFIRINOX chemotherapy and Stereotactic Body Radiation Therapy (SBRT) prior to surgery in patients with pancreatic cancer is safe and well tolerated. This study will obtain preliminary data on the response of the cancer to this therapy by Magnetic Resonance Imaging (MRI) and by studying the cancer after it is resected surgically. In addition, the investigators will perform biochemical studies on the tumor tissue obtained from your tissue biopsy as well as from the tumor removed by the surgeon in order to measure the effect of treatment with FOLFIRINOX and SBRT on several proteins that may be important in the behavior of pancreatic cancer cells. The data obtained from this trial will be extremely valuable to help improve the approach to treating pancreatic cancer in the future. If you do not undergo surgery after completion of FOLFIRINOX + SBRT, the investigators will request a second biopsy of the tumor under computer tomography (CT) -guidance in order to measure the effect of treatment on your tumor.
Interventions
- DRUG Modified FOLFIRINOX
- RADIATION Stereotactic Body Radiotherapy (SBRT)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2011-11 |
| Est. Completion | 2015-03 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01446458
The ClinicalTrials.gov registry entry for NCT01446458 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 13 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Emory University, which has 1,208 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Modified FOLFIRINOX is the first listed.
NCT01446458 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01446458 about?
NCT01446458 is a clinical study titled "Phase I Study of Stereotactic Body Radiation Therapy and FOLFIRINOX in the Neoadjuvant Therapy of Pancreatic Cancer". The purpose of this study is to determine whether using FOLFIRINOX chemotherapy and Stereotactic Body Radiation Therapy (SBRT) prior to surgery in patients with pancreatic cancer is safe and well tolerated. This study will obtain preliminary data on the response of the cancer to this therapy by Magn...
What is the current status of trial NCT01446458?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 2011-11. Estimated completion is 2015-03.
What interventions are being tested in trial NCT01446458?
The interventions under investigation include: Modified FOLFIRINOX (DRUG), Stereotactic Body Radiotherapy (SBRT) (RADIATION).
Who is sponsoring clinical trial NCT01446458?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
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