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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: Completed Early Phase 1 study, sponsored by University of Maryland, Baltimore.
NCT01992705 is a Early Phase 1 study that has completed, run by University of Maryland, Baltimore. The registered enrollment target is 8 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
To determine the rate of downstaging to resectability in patients with borderline resectable pancreatic cancer receiving FOLFIRINOX and SBRT as preoperative therapy (AGGC 6th edition).
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 |
What the finished NCT01992705 record still lists
NCT01992705 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (85% lower).
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 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01992705's enrollment target sits among peer trials
8 1783rd of 2000 higher than 176 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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