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Borderline Pancreas Study: FOLFIRINOX +SBRT

NCT01992705 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2019-08-19

No results posted yet for this 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

Conditions

  • Resectable Pancreatic Cancer

Interventions

OTHER

Chemotherapy(FOLFIRINOX) + SBRT prior to surgery if applicable

Patients will receive chemotherapy (21d/cycle for a total of 4 cycles) plus SBRT before screening for surgical resection of the pancreas.

DRUG

-Oxaliplatin 85 mg/m2 IV on Day 1

Oxaliplatin 85 mg/m2 IV on Day 1 of each cycle (21d/cycle for a total of 4 cycles).

DRUG

-Irinotecan 180 mg/m2 IV on Day 1

Irinotecan 180 mg/m2 IV on Day 1 of each cycle (21d/cycle for a total of 4 cycles).

DRUG

-5-FU (Fluorouracil) 2,400 mg/m2 IV over 46-48 hours

5-FU (Fluorouracil) 2,400 mg/m2 IV over 46-48 hours of each cycle (21d/cycle for a total of 4 cycles.

Sponsors & Collaborators

  • University of Maryland, Baltimore

    lead OTHER

Principal Investigators

  • Shahed Badiyan, MD · University of Maryland, College Park

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2018-09-27
Completion
2018-09-27

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01992705 on ClinicalTrials.gov