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Active, Not Recruiting

NCT Number: NCT04986930

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Pancreatic Adenocarcinoma Pancreatic Cancer Non-resectable

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Asan Medical Center

Seoul, 05505, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SBRT+mFOLFIRINOX

Radiation

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

Drug

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 outcomes

  1. 1-year progression-free survival rate

    Time frame: 1 year

    Proportion of patients without disease progression or death

Secondary outcomes

  1. Overall survival

    Time frame: 1 year

    Time between randomization and death of any cause

  2. Progression-free survival

    Time frame: 1 year

    Time between randomization and disease progression or death of any cause

  3. Overall response rates

    Time frame: 1 year

    Tumor response per Response Evaluation Criteria in Solid Tumors version 1.1

  4. Adverse events

    Time frame: 1 year

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

  5. Surgical resection rate

    Time frame: 1 year

    Proportion of patients who underwent curative-intent surgery

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Registry information

Official study title

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

Acronym: SABER

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Aug 3, 2021
Registry last updated
Jan 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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