Neoadjuvant Modified FOLFIRINOX and Stereotactic Body Radiation Therapy in Borderline Resectable Pancreatic Adenocarcinoma
|ClinicalTrials.gov Identifier: NCT03099265|
Recruitment Status : Active, not recruiting
First Posted : April 4, 2017
Last Update Posted : May 18, 2020
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Drug: neoadjuvant mFOLFIRINOX Drug: Stereotactic body radiotherapy (SBRT)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study to Evaluate Neoadjuvant Modified FOLFIRINOX and Stereotactic Body Radiation Therapy in Borderline Resectable Pancreatic Adenocarcinoma|
|Actual Study Start Date :||June 26, 2017|
|Estimated Primary Completion Date :||February 2022|
|Estimated Study Completion Date :||August 2022|
Experimental: patients with borderline resectable pancreatic adenocarcinoma
Borderline resectable disease will be defined by NCCN criteria, and determined centrally by review of a diagnostic pancreas protocol CT scan and/or MRI scan with contrast by a dedicated surgical oncologist and radiologist.
Drug: neoadjuvant mFOLFIRINOX
Patients will receive 8 cycles of mFOLFIRINOX every 2 weeks. mFOLFIRINOX will be dosed as follows: Oxaliplatin 85 mg/m2, followed by folinic acid 400 mg/m2 infused over 120 minutes and irinotecan 135 mg/m2 infused over 90 minutes, followed by 5-fluorouracil 300 mg/m2 IV bolus, followed by 2,400 mg/m2 continuous infusion for 46 hours. Levoleucovorin may be substituted for folinic acid at a dose of 200 mg/m2 infused over 120 minutes.
Drug: Stereotactic body radiotherapy (SBRT)
Stereotactic body radiotherapy (SBRT) will be delivered to the primary tumor and any adjacent involved nodes to 33 Gy in 5 fractions over the course of 2 weeks, and within 4 weeks of chemotherapy.
- R0 resection rate [ Time Frame: Up to 40 weeks ]The primary outcome of this study is the R0 resection rate in patients with BRPC treated with neoadjuvant mFOLFIRINOX and SBRT. R0 resection indicates a microscopically margin-negative resection, in which no gross or microscopic tumor remains in the primary tumor bed.
- Radiographic response to neoadjuvant therapy [ Time Frame: Up to 40 weeks ]Response to treatment will be assessed by the treating physicians and investigators according to RECIST version 1.1
- Pathologic response to neoadjuvant therapy [ Time Frame: Up to 40 weeks ]A pathologic complete response is defined as the absence of residual invasive disease at the completion of the neoadjuvant treatment.
- Rates of recurrence [ Time Frame: Up to 40 weeks ]Local only, systemic only, and local or systemic rates of recurrence
- Progression free survival [ Time Frame: Up to 5 years ]Estimated using Kaplan-Meier analysis
- Overall survival [ Time Frame: Up to 5 years ]Estimated using Kaplan-Meier analysis
- Grade 3 or greater acute and late gastrointestinal toxicity [ Time Frame: Up to 40 weeks ]To determine rates of grade 3 or greater gastrointestinal toxicity, including acute toxicities occurring within 3 months of treatment, and late toxicities occurring over 3 months after completion of radiation.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03099265
|United States, Connecticut|
|Smilow Cancer Hospital|
|New Haven, Connecticut, United States, 06510|
|Principal Investigator:||Kimberly Johung, MD, PhD||Yale University|