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Pancreatic AdenocarcinomaPhase 2SABERNCT04986930

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

A Phase 2 study testing SBRT+mFOLFIRINOX and mFOLFIRINOX in people with Pancreatic Adenocarcinoma and Pancreatic Cancer Non-resectable, run by Asan Medical Center at 1 site in South Korea.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 years and older
What is being tested?
SBRT+mFOLFIRINOX and mFOLFIRINOX
Could I receive a placebo?
No, everyone receives an active treatment
How many people
92 participants
Where
1 siteSouth Korea
Study dates
14 Aug 2021to 14 Dec 2025
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

South Korea1 site

  • Asan Medical Center

    Seoul, 05505

Other trials in South Korea

About this study

Official title: Randomized Phase 2 Study of mFOLFIRINOX With or Without Stereotactic Body Radiotherapy in Patients With 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

Being tested
SBRT+mFOLFIRINOX, mFOLFIRINOX
Keywords
Pancreatic adenocarcinoma, Locally advanced unresectable, mFOLFIRINOX, Stereotactic body radiotherapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SBRT+mFOLFIRINOXRadiation

    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

  • mFOLFIRINOXDrug

    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

Study groups in NCT04986930
Study groupRoleWhat they receive
SBRT+mFOLFIRINOXExperimental* 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
Receives: Radiation: SBRT+mFOLFIRINOX
mFOLFIRINOXActive comparator-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
Receives: Drug: mFOLFIRINOX

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 1-year progression-free survival rate

    Proportion of patients without disease progression or death

    Measured: 1 year

Secondary outcomes (5)

  1. Overall survival

    Time between randomization and death of any cause

    Measured: 1 year

  2. Progression-free survival

    Time between randomization and disease progression or death of any cause

    Measured: 1 year

  3. Overall response rates

    Tumor response per Response Evaluation Criteria in Solid Tumors version 1.1

    Measured: 1 year

  4. Adverse events

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

    Measured: 1 year

  5. Surgical resection rate

    Proportion of patients who underwent curative-intent surgery

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Aug 2021
  2. Study start14 Aug 2021
  3. Primary completion23 Jan 2025
  4. Study completion14 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
92 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04986930
Sponsor's protocol ID
SABER
Acronym
SABER
Status last verified
Jan 2025
First submitted
27 Jul 2021
Last updated
28 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Balaban EP, Mangu PB, Khorana AA, Shah MA, Mukherjee S, Crane CH, Javle MM, Eads JR, Allen P, Ko AH, Engebretson A, Herman JM, Strickler JH, Benson AB 3rd, Urba S, Yee NS. Locally Advanced, Unresectable Pancreatic Cancer: American Society of Clinical Oncology Clinical Practice Guideline. J Clin Oncol. 2016 Aug 1;34(22):2654-68. doi: 10.1200/JCO.2016.67.5561. Epub 2016 May 31.

    PubMed 27247216

  • Hammel P, Huguet F, van Laethem JL, Goldstein D, Glimelius B, Artru P, Borbath I, Bouche O, Shannon J, Andre T, Mineur L, Chibaudel B, Bonnetain F, Louvet C; LAP07 Trial Group. Effect of Chemoradiotherapy vs Chemotherapy on Survival in Patients With Locally Advanced Pancreatic Cancer Controlled After 4 Months of Gemcitabine With or Without Erlotinib: The LAP07 Randomized Clinical Trial. JAMA. 2016 May 3;315(17):1844-53. doi: 10.1001/jama.2016.4324.

    PubMed 27139057

  • Loehrer PJ Sr, Feng Y, Cardenes H, Wagner L, Brell JM, Cella D, Flynn P, Ramanathan RK, Crane CH, Alberts SR, Benson AB 3rd. Gemcitabine alone versus gemcitabine plus radiotherapy in patients with locally advanced pancreatic cancer: an Eastern Cooperative Oncology Group trial. J Clin Oncol. 2011 Nov 1;29(31):4105-12. doi: 10.1200/JCO.2011.34.8904. Epub 2011 Oct 3.

    PubMed 21969502

  • Murphy JE, Wo JY, Ryan DP, Jiang W, Yeap BY, Drapek LC, Blaszkowsky LS, Kwak EL, Allen JN, Clark JW, Faris JE, Zhu AX, Goyal L, Lillemoe KD, DeLaney TF, Fernandez-Del Castillo C, Ferrone CR, Hong TS. Total Neoadjuvant Therapy With FOLFIRINOX Followed by Individualized Chemoradiotherapy for Borderline Resectable Pancreatic Adenocarcinoma: A Phase 2 Clinical Trial. JAMA Oncol. 2018 Jul 1;4(7):963-969. doi: 10.1001/jamaoncol.2018.0329.

    PubMed 29800971

  • Yoo C, Jeong H, Park I, Cheon J, Ryoo BY, Kim KP, Hwang DW, Song KB, Lee W, Kim SC, Song TJ, Oh D, Lee JS, Lee SS, Park JH. Modified FOLFIRINOX with or Without Stereotactic Body Radiation in Locally Advanced Unresectable Pancreatic Cancer (SABER): A Randomized Open-Label Phase 2 Trial. Ann Surg Oncol. 2026 Aug;33(8):7503-7511. doi: 10.1245/s10434-026-19762-3. Epub 2026 May 7.

    PubMed 42098550

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SBRT+mFOLFIRINOX and mFOLFIRINOX in people with Pancreatic Adenocarcinoma and Pancreatic Cancer Non-resectable, run by Asan Medical Center at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 28 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

1-year progression-free survival rate (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04986930, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2025.

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