NCT01446458|CompletedPhase 1DMC
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Sponsor study identifier
Secondary identifiers
OTHER · Other
interventional
13
1 country
2
Study Start
November 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2015
Actual (reported)Study Completion
March 2015
Actual (reported)The purpose of this study is to determine whether using FOLFIRINOX chemotherapy and Stereotactic Body Radiation Therapy (SBRT) prior to surgery in patients with pancreatic cancer is safe and well tolerated. This study will obtain preliminary data on the response of the cancer to this therapy by Magnetic Resonance Imaging (MRI) and by studying the cancer after it is resected surgically. In addition, the investigators will perform biochemical studies on the tumor tissue obtained from your tissue biopsy as well as from the tumor removed by the surgeon in order to measure the effect of treatment with FOLFIRINOX and SBRT on several proteins that may be important in the behavior of pancreatic cancer cells. The data obtained from this trial will be extremely valuable to help improve the approach to treating pancreatic cancer in the future. If you do not undergo surgery after completion of FOLFIRINOX + SBRT, the investigators will request a second biopsy of the tumor under computer tomography (CT) -guidance in order to measure the effect of treatment on your tumor.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2015
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 26, 2011
Actual (reported)October 5, 2011
Actual (reported)November 2011
Date type not reportedThis date has not been verified as actual or estimated.
March 2015
Actual (reported)March 2015
Actual (reported)Maximum tolerated total dose of stereotactic body radiation to patients with resectable or borderline resectable pancreas cancer following FOLFIRINOX chemotherapy
A standard 3 + 3 design will be used for evaluating the safety and tolerability of SBRT radiation doses. Any grade 3 liver, gastric, small bowel or spinal cord toxicity or any grade 4 toxicity (hematologic or other non-hematologic except for diarrhea) will be considered a dose limiting toxicity (DLT). Each cohort will consist of 3 patients, unless 1 of the patients experiences a DLT in which case the cohort will be expanded to 6 patients. The maximum tolerated dose (MTD) will be defined as the dose level below that which results in a DLT in 2 or more of the 6 patients in a cohort.
Four weeks
Clinical and pathologic objective response rate as measured by MRI (clinical response) and histopathology and rate of complete resection (R0) (pathologic response)
ten weeks
5-Fluorouracil, Oxaliplatin, Irinotecan are administered as a modified FOLFIRINOX regimen every 15 days. Subjects receive bi-weekly cycles of therapy on the 1st week, the 3rd week, the 5th week and finally the 7th week for a total of 4 cycles. Assessments include history and physical, laboratory tests on a weekly basis throughout the treatment period prior to and including week 8 assessment for stereotactic body radiotherapy (SBRT).
Patients receive modified FOLFIRINOX Chemotherapy for 4 cycles (1 cycle = 15 days). Modified FOLFIRINOX: Oxaliplatin 85 mg/m2 intravenous infusion on day 1; Irinotecan 180 mg/m2 intravenous infusion on day 1; 5-Fluorouracil 2400 mg/m2 continuous intravenous infusion on days 1 to 3; pegylated filgrastim (neulasta) 6 mg subcutaneous injection on day 3.
Emory University Hospital Midtown
Atlanta, Georgia, 30308, United States
Emory University Winship Cancer Institute
Atlanta, Georgia, 30322, United States
Shaib WL, Hawk N, Cassidy RJ, Chen Z, Zhang C, Brutcher E, Kooby D, Maithel SK, Sarmiento JM, Landry J, El-Rayes BF. A Phase 1 Study of Stereotactic Body Radiation Therapy Dose Escalation for Borderline Resectable Pancreatic Cancer After Modified FOLFIRINOX (NCT01446458). Int J Radiat Oncol Biol Phys. 2016 Oct 1;96(2):296-303. doi: 10.1016/j.ijrobp.2016.05.010. Epub 2016 May 24.
Natalyn N. Hawk, MD, PhD
Emory University Winship Cancer Institute
13 participants (actual enrollment reported by the registry).
First Submitted
September 26, 2011
First Posted
October 5, 2011
Study Start
November 2011
Date type not reportedThis date has not been verified as actual or estimated.
Epidural Analgesia Use in Pancreatic Resections
Patients will receive Stereotactic Body Radiotherapy (SBRT) to pancreas tumor 2 weeks following chemotherapy. SBRT is given in 3 daily fractions at designated doses per treatment cohort. Starting dose level-Dose level 1: 10 Gy SBRT to primary tumor volume (PTV) / 2 Gy SBRT to the retroperitoneal margin daily for a total Gy to Gross tumor volume (GTV) of 36 Gy. There are weekly toxicity assessments for 4 weeks. This is a standard 3 + 3 design with 4 dose levels.
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Primary Completion
March 2015
Actual (reported)Study Completion
March 2015
Actual (reported)Last Updated
March 22, 2016
Record last verified: 2016-03
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