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Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Pancreatic Cancer

Antineoplastic Agents

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Oxaliplatin

Leucovorin

Fluorouracil

Irinotecan

* 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

-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

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

SBRT+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

mFOLFIRINOX

Changhoon Yoo, MD, PhD

Changhoon Yoo, MD

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

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

Proportion of patients without disease progression or death

Time between randomization and death of any cause

Time between randomization and disease progression or death of any cause

Tumor response per Response Evaluation Criteria in Solid Tumors version 1.1

Any unintended events graded per National Cancer Institute Common Terminology Criteria for Adverse Events version 5

Proportion of patients who underwent curative-intent surgery

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
mFOLFIRINOX With or Without Stereotactic Body Radiotherapy in Locally Advanced Pancreatic Adenocarcinoma	NCT04986930	Pancreatic Aden... Pancreatic Canc...	SBRT+mFOLFIRINO... mFOLFIRINOX	19 Years -	Asan Medical Center
mFOLFIRINOX With or Without Stereotactic Body Radiotherapy in Locally Advanced Pancreatic Adenocarcinoma	NCT04986930	Pancreatic Aden... Pancreatic Canc...	SBRT+mFOLFIRINO... mFOLFIRINOX	19 Years -	Asan Medical Center

Spots Global Cancer Trial Database for sbrt+mfolfirinox