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NCT01992705 · ClinicalTrials.gov registry record · Early Phase 1
Borderline Pancreas Study: FOLFIRINOX +SBRT
A Early Phase 1 study, sponsored by University of Maryland, Baltimore.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 8
- Enrollment target
NCT01992705 is a Early Phase 1 study that has completed, run by University of Maryland, Baltimore. The registered enrollment target is 8 participants.
The verdict
NCT01992705, a Early Phase 1 study, has completed, sponsored by University of Maryland, Baltimore.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 8 participants
- Enrollment target
Study Summary
Primary Objective: To determine the rate of downstaging to resectability in patients with borderline resectable pancreatic cancer receiving FOLFIRINOX and SBRT as preoperative therapy. Secondary Objective(s): 1. To assess the disease-free-survival, overall survival, time to recurrence and site of recurrence in patients with borderline resectable pancreatic cancer receiving preoperative FOLFIRINOX followed by SBRT 2. To investigate the safety and tolerability of FOLFIRINOX and SBRT in patients with resectable pancreatic cancer 3. To determine the radiologic and pathological response associated with preoperative SBRT and FOLFIRINOX therapy 4. To assess quality of life through and after treatment using the FACT-Hep questionnaire
Interventions
- OTHER Chemotherapy(FOLFIRINOX) + SBRT prior to surgery if applicable
- DRUG -Oxaliplatin 85 mg/m2 IV on Day 1
- DRUG -Irinotecan 180 mg/m2 IV on Day 1
- DRUG -5-FU (Fluorouracil) 2,400 mg/m2 IV over 46-48 hours
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2014-03 |
| Est. Completion | 2018-09-27 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01992705
The ClinicalTrials.gov registry entry for NCT01992705 describes a study currently listed as completed, categorized as Early 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 Maryland, Baltimore, which has 560 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Chemotherapy(FOLFIRINOX) + SBRT prior to surgery if applicable is the first listed.
NCT01992705 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01992705 about?
NCT01992705 is a clinical study titled "Borderline Pancreas Study: FOLFIRINOX +SBRT". Primary Objective: To determine the rate of downstaging to resectability in patients with borderline resectable pancreatic cancer receiving FOLFIRINOX and SBRT as preoperative therapy. Secondary Objective(s): 1. To assess the disease-free-survival, overall survival, time to recurrence and site of ...
What is the current status of trial NCT01992705?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 8 participants. The study started on 2014-03. Estimated completion is 2018-09-27.
What interventions are being tested in trial NCT01992705?
The interventions under investigation include: Chemotherapy(FOLFIRINOX) + SBRT prior to surgery if applicable (OTHER), -Oxaliplatin 85 mg/m2 IV on Day 1 (DRUG), -Irinotecan 180 mg/m2 IV on Day 1 (DRUG), -5-FU (Fluorouracil) 2,400 mg/m2 IV over 46-48 hours (DRUG).
Who is sponsoring clinical trial NCT01992705?
This trial is sponsored by University of Maryland, Baltimore, which has 560 total clinical trials registered on ClinicalTrials.gov.
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