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

  • STATUS
    Recruiting
  • End date
    Aug 14, 2024
  • participants needed
    92
  • sponsor
    Asan Medical Center
Updated on 25 March 2022

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

Details
Condition Pancreatic Adenocarcinoma, Pancreatic Cancer Non-resectable
Treatment mFOLFIRINOX, SBRT+mFOLFIRINOX
Clinical Study IdentifierNCT04986930
SponsorAsan Medical Center
Last Modified on25 March 2022

Eligibility

Yes No Not Sure

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
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