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NCT03099265 · ClinicalTrials.gov registry record · Phase 2
Neoadjuvant Modified FOLFIRINOX and Stereotactic Body Radiation Therapy in Borderline Resectable Pancreatic Adenocarcinoma
A Phase 2 study, sponsored by Yale University.
- Terminated
- Registry status
- Phase 2
- Development phase
- 9
- Enrollment target
NCT03099265 is a Phase 2 study that was terminated before completion, run by Yale University. The registered enrollment target is 9 participants.
The verdict
NCT03099265, a Phase 2 study, was terminated before completion, sponsored by Yale University.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 9 participants
- Enrollment target
Study Summary
Surgical resection is the only potentially curative treatment for patients with pancreatic cancer. Patients with BRPC have tumors in close contact with the vasculature but not to the extent that resection is prohibited. Nonetheless, retrospective studies have shown that immediate resection in these patients is associated with an increased risk of positive margins, and a margin positive resection does not improve survival over that of patients with unresectable disease. Moreover, even in those patients where a successful resection is achieved, there is a high rate of early metastatic progression suggesting that micrometastatic disease is often present at diagnosis. Therefore neoadjuvant therapy is likely to improve outcomes in patients with BRPC to increase the likelihood of achieving a margin negative resection, provide early control of occult micrometastatic disease, and select those patients without systemic progression who would benefit from surgical resection.
Interventions
- DRUG neoadjuvant mFOLFIRINOX
- DRUG Stereotactic body radiotherapy (SBRT)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2017-06-26 |
| Est. Completion | 2019-09-18 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03099265
The ClinicalTrials.gov registry entry for NCT03099265 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 9 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Yale University, which has 1,492 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which neoadjuvant mFOLFIRINOX is the first listed.
NCT03099265 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03099265 about?
NCT03099265 is a clinical study titled "Neoadjuvant Modified FOLFIRINOX and Stereotactic Body Radiation Therapy in Borderline Resectable Pancreatic Adenocarcinoma". Surgical resection is the only potentially curative treatment for patients with pancreatic cancer. Patients with BRPC have tumors in close contact with the vasculature but not to the extent that resection is prohibited. Nonetheless, retrospective studies have shown that immediate resection in these ...
What is the current status of trial NCT03099265?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 9 participants. The study started on 2017-06-26. Estimated completion is 2019-09-18.
What interventions are being tested in trial NCT03099265?
The interventions under investigation include: neoadjuvant mFOLFIRINOX (DRUG), Stereotactic body radiotherapy (SBRT) (DRUG).
Who is sponsoring clinical trial NCT03099265?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
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