MFOLFIRINOX with or Without Stereotactic Body Radiotherapy in Locally Advanced Pancreatic Adenocarcinoma (SABER)

Asan Medical Center

Status and phase: Active, not recruiting; Phase 2

Conditions: Pancreatic Cancer Non-resectable; Pancreatic Adenocarcinoma

Treatments: Drug: mFOLFIRINOX; Radiation: SBRT+mFOLFIRINOX

Study type: Interventional

Funder types: Other

Identifiers

NCT04986930

SABER

Details and patient eligibility

About

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

Enrollment: 92 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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92 participants in 2 patient groups

SBRT+mFOLFIRINOX

Experimental group

Description:

* 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

Treatment:

Radiation: SBRT+mFOLFIRINOX

mFOLFIRINOX

Active Comparator group

Description:

-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

Treatment:

Drug: mFOLFIRINOX