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

Phase 2

Recruiting

• Conditions: Pancreatic Adenocarcinoma; Pancreatic Cancer Non-resectable
• Interventions: Drug: mFOLFIRINOX; Radiation: SBRT+mFOLFIRINOX

• Registration Number: NCT04986930
• Lead Sponsor: Asan Medical Center

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-07-27
• Study First Submitted QC: 2021-07-27
• Study First Posted: 2021-08-03
• Study Start: 2021-08-14
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-18
• Last Update Posted: 2023-07-19
• Primary Completion: 2024-08-14
• Study Completion: 2025-08-14

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 92

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
mFOLFIRINOX	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
SBRT+mFOLFIRINOX	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

Primary Outcome Measures

Name	Time	Method
1-year progression-free survival rate	1 year	Proportion of patients without disease progression or death

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of