Neoadjuvant Modified FOLFIRINOX and Stereotactic Body Radiation Therapy in Borderline Resectable Pancreatic Adenocarcinoma
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|ClinicalTrials.gov Identifier: NCT03099265|
Recruitment Status : Active, not recruiting
First Posted : April 4, 2017
Last Update Posted : January 21, 2019
|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|