NCT04986930

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

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 92 (estimated)
• Sponsor: Asan Medical Center · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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

Conditions

• Pancreatic Adenocarcinoma
• Pancreatic Cancer Non-resectable

Interventions

Type	Name	Description
RADIATION	SBRT+mFOLFIRINOX	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
DRUG	mFOLFIRINOX	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

Timeline

• Start date: 2021-08-14
• Primary completion: 2025-01-23
• Completion: 2025-12-14
• First posted: 2021-08-03
• Last updated: 2025-01-28

Locations

1 site across 1 country: South Korea