Borderline Pancreas Study: FOLFIRINOX +SBRT
Public ClinicalTrials.gov record NCT01992705. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Neoadjuvant FOLFIRINOX and Stereotactic Body Radiotherapy (SBRT) Followed by Definitive Surgery for Patients With Borderline Resectable Pancreatic Adenocarcinoma: A Single-Arm Pilot Study
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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
Study identification
- NCT ID
- NCT01992705
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Early Phase 1
- Enrollment
- 8 participants
Conditions and interventions
Conditions
Interventions
- 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
Other · Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 28, 2014
- Primary completion
- Sep 26, 2018
- Completion
- Sep 26, 2018
- Last update posted
- Aug 18, 2019
2014 – 2018
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Maryland Medical Center | Baltimore | Maryland | 21201 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01992705, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 18, 2019 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01992705 live on ClinicalTrials.gov.