mFOLFIRINOX With or Without Stereotactic Body Radiotherapy in Locally Advanced Pancreatic Adenocarcinoma

Study Overview
=================
Brief Summary
-----------------
Modified FOLFIRINOX (mFOLFIRINOX) is the standard of care for patients with locally advanced pancreatic adenocarcinoma. While radiotherapy has been investigated for the management of resectable or locally advanced pancreatic adenocarcinoma, its role in the era of modern chemotherapy is not clear. Stereotactic body radiotherapy (SBRT) is the novel technique of radiotherapy to enhance the dose of radiotherapy to the target tumor lesion. This trial aims to compare the efficacy and safety of mFOLFIRINOX with or without SBRT in patients with locally advanced pancreatic adenocarcinoma

Official Title
-----------------
Randomized Phase 2 Study of mFOLFIRINOX With or Without Stereotactic Body Radiotherapy in Patients With Locally Advanced Pancreatic Adenocarcinoma

Conditions
-----------------
Pancreatic Adenocarcinoma, Pancreatic Cancer Non-resectable

Intervention / Treatment
-----------------
* Radiation: SBRT+mFOLFIRINOX
* Drug: mFOLFIRINOX


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Informed consent Age 19 years or greater Cytologically or histologically confirmed pancreatic adenocarcinoma Locally advanced unresectable disease per National Comprehensive Cancer Network resectability criteria No active infection except chronic hepatitis on anti-viral therapy Eastern Cooperative Oncology Group performance status 0 or 1 Body weight > 30 kg Normal organ and bone marrow function Exclusion Criteria: Gastrointestinal obstruction Active gastrointestinal bleeding or ulcer Clinically significant cardiac disease or myocardial infarction within 6 months before the randomization Histology other than adenocarcinoma (adenosquamous or neuroendocrine tumors) Pregnancy or breastfeeding

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SBRT+mFOLFIRINOX<br>Stereotactic body radiotherapy: 3500 cGy (5 fractions) mFOLFIRINOX, every 2 weeks Oxaliplatin, 85 mg/m2, intravenous, day 1 Leucovorin, 400 mg/m2, intravenous, day 1 Irinotecan, 150 mg/m2, intravenous, day 1 fluorouracil, 2,400 mg/m2, intravenous, day 1-2 | Radiation: SBRT+mFOLFIRINOX<br>* Stereotactic body radiotherapy: 3500 cGy (5 fractions) mFOLFIRINOX, every 2 weeks Oxaliplatin, 85 mg/m2, intravenous, day 1 Leucovorin, 400 mg/m2, intravenous, day 1 Irinotecan, 150 mg/m2, intravenous, day 1 fluorouracil, 2,400 mg/m2, intravenous, day 1-2<br>|
| Active Comparator: mFOLFIRINOX<br>-mFOLFIRINOX, every 2 weeks Oxaliplatin, 85 mg/m2, intravenous, day 1 Leucovorin, 400 mg/m2, intravenous, day 1 Irinotecan, 150 mg/m2, intravenous, day 1 fluorouracil, 2,400 mg/m2, intravenous, day 1-2 | Drug: mFOLFIRINOX<br>* mFOLFIRINOX, every 2 weeks Oxaliplatin, 85 mg/m2, intravenous, day 1 Leucovorin, 400 mg/m2, intravenous, day 1 Irinotecan, 150 mg/m2, intravenous, day 1 fluorouracil, 2,400 mg/m2, intravenous, day 1-2<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1-year progression-free survival rate | Proportion of patients without disease progression or death | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | Time between randomization and death of any cause | 1 year | 
| Progression-free survival | Time between randomization and disease progression or death of any cause | 1 year | 
| Overall response rates | Tumor response per Response Evaluation Criteria in Solid Tumors version 1.1 | 1 year | 
| Adverse events | Any unintended events graded per National Cancer Institute Common Terminology Criteria for Adverse Events version 5 | 1 year | 
| Surgical resection rate | Proportion of patients who underwent curative-intent surgery | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pancreatic adenocarcinoma, Locally advanced unresectable, mFOLFIRINOX, Stereotactic body radiotherapy