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

July 18, 2023 updated by: Changhoon Yoo, Asan Medical Center

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

92

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Changhoon Yoo, MD, PhD
  • Phone Number: +82-2-3010-1727
  • Email: yooc@amc.seoul.kr

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 05505
        • Recruiting
        • Asan Medical Center
        • Contact:
          • Changhoon Yoo, MD
        • Principal Investigator:
          • Changhoon Yoo, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
1-year progression-free survival rate
Time Frame: 1 year
Proportion of patients without disease progression or death
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 1 year
Time between randomization and death of any cause
1 year
Progression-free survival
Time Frame: 1 year
Time between randomization and disease progression or death of any cause
1 year
Overall response rates
Time Frame: 1 year
Tumor response per Response Evaluation Criteria in Solid Tumors version 1.1
1 year
Adverse events
Time Frame: 1 year
Any unintended events graded per National Cancer Institute Common Terminology Criteria for Adverse Events version 5
1 year
Surgical resection rate
Time Frame: 1 year
Proportion of patients who underwent curative-intent surgery
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asan Medical Center

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 14, 2021

Primary Completion (Estimated)

August 14, 2024

Study Completion (Estimated)

August 14, 2025

Study Registration Dates

First Submitted

July 27, 2021

First Submitted That Met QC Criteria

July 27, 2021

First Posted (Actual)

August 3, 2021

Study Record Updates

Last Update Posted (Actual)

July 19, 2023

Last Update Submitted That Met QC Criteria

July 18, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SABER

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pancreatic Adenocarcinoma

Clinical Trials on SBRT+mFOLFIRINOX

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Türkiye

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe