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

Sponsor
Asan Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT04986930
Collaborator
(none)
92
Enrollment
1
Location
2
Arms
36
Anticipated Duration (Months)
2.6
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
92 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Randomized Phase 2 Study of mFOLFIRINOX With or Without Stereotactic Body Radiotherapy in Patients With Locally Advanced Pancreatic Adenocarcinoma
Actual Study Start Date :
Aug 14, 2021
Anticipated Primary Completion Date :
Aug 14, 2023
Anticipated Study Completion Date :
Aug 14, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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

Radiation: 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
Active Comparator: 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

Drug: 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

Outcome Measures

Primary Outcome Measures

  1. 1-year progression-free survival rate [1 year]

    Proportion of patients without disease progression or death

Secondary Outcome Measures

  1. Overall survival [1 year]

    Time between randomization and death of any cause

  2. Progression-free survival [1 year]

    Time between randomization and disease progression or death of any cause

  3. Overall response rates [1 year]

    Tumor response per Response Evaluation Criteria in Solid Tumors version 1.1

  4. Adverse events [1 year]

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

  5. Surgical resection rate [1 year]

    Proportion of patients who underwent curative-intent surgery

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Asan Medical Center Seoul Korea, Republic of 05505

Sponsors and Collaborators

  • Asan Medical Center

Investigators

  • Principal Investigator: Changhoon Yoo, MD, PhD, Asan Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Changhoon Yoo, Associate Professor, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT04986930
Other Study ID Numbers:
  • SABER
First Posted:
Aug 3, 2021
Last Update Posted:
Jan 25, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Changhoon Yoo, Associate Professor, Asan Medical Center
Pancreatic adenocarcinoma
Locally advanced unresectable
mFOLFIRINOX
Stereotactic body radiotherapy
Additional relevant MeSH terms:
Adenocarcinoma

Study Results

No Results Posted as of Jan 25, 2022