Borderline Pancreas Study: FOLFIRINOX +SBRT

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
University of Maryland, Baltimore
Study ID
NCT01992705
Phase
EARLY_PHASE1
Status
Completed

Conditions

  • Resectable Pancreatic Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Chemotherapy(FOLFIRINOX) + SBRT prior to surgery if applicable — OTHER
    Patients will receive chemotherapy (21d/cycle for a total of 4 cycles) plus SBRT before screening for surgical resection of the pancreas.
  • -Oxaliplatin 85 mg/m2 IV on Day 1 — DRUG
    Oxaliplatin 85 mg/m2 IV on Day 1 of each cycle (21d/cycle for a total of 4 cycles).
  • -Irinotecan 180 mg/m2 IV on Day 1 — DRUG
    Irinotecan 180 mg/m2 IV on Day 1 of each cycle (21d/cycle for a total of 4 cycles).
  • -5-FU (Fluorouracil) 2,400 mg/m2 IV over 46-48 hours — DRUG
    5-FU (Fluorouracil) 2,400 mg/m2 IV over 46-48 hours of each cycle (21d/cycle for a total of 4 cycles.

Study Details

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

Key Dates

Start date
Mar 31, 2014
Status verified
Aug 2019
Primary completion
Sep 27, 2018
Completion
Sep 27, 2018

Study Design

Enrollment
8 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Chemotherapy+SBRT prior to surgery if applicable
    FOLFIRINOX Drugs: * Calcium Folinate (Folinic Acid) 400 mg IV on Day 1 of each cycle (21d/cycle for a total of 4 cycles. Stereotactic Body Radiotherapy (SBRT): 30 Gy in 5 fractions given to radiographically defined pancreatic mass alone

Primary Outcome Measure

Rate of downstaging to resectability in patients with borderline resectable pancreatic cancer receiving FOLFIRINOX and SBRT as preoperative therapy. [ Time Frame: Participants will be followed from randomization up to 120 months or death (from any cause) whichever comes first. ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Maryland Medical CenterBaltimoreMaryland21201-

Find similar trials in Baltimore, MD

By research site
University of Maryland Medical Center· Baltimore, MD

Related Studies