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

Primary Purpose

Pancreatic Adenocarcinoma, Pancreatic Cancer Non-resectable

Status

Recruiting

Phase

Phase 2

Locations

Korea, Republic of

Study Type

Interventional

Intervention

SBRT+mFOLFIRINOX

mFOLFIRINOX

About this trial

This is an interventional treatment trial for Pancreatic Adenocarcinoma focused on measuring Pancreatic adenocarcinoma, Locally advanced unresectable, mFOLFIRINOX, Stereotactic body radiotherapy

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Asan Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SBRT+mFOLFIRINOX

mFOLFIRINOX

Arm Description

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, 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

Outcomes

Primary Outcome Measures

1-year progression-free survival rate

Proportion of patients without disease progression or death

Secondary Outcome Measures

Overall survival

Time between randomization and death of any cause

Progression-free survival

Time between randomization and disease progression or death of any cause

Overall response rates

Tumor response per Response Evaluation Criteria in Solid Tumors version 1.1

Adverse events

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

Surgical resection rate

Proportion of patients who underwent curative-intent surgery

Full Information

NCT ID

NCT04986930

First Posted

July 27, 2021

Last Updated

July 18, 2023

Sponsor

Asan Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT04986930

Brief Title

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

Acronym

SABER

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

August 14, 2021 (Actual)

Primary Completion Date

August 14, 2024 (Anticipated)

Study Completion Date

August 14, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Asan Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pancreatic Adenocarcinoma, Pancreatic Cancer Non-resectable

Keywords

Pancreatic adenocarcinoma, Locally advanced unresectable, mFOLFIRINOX, Stereotactic body radiotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

92 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

SBRT+mFOLFIRINOX

Arm Type

Experimental

Arm Description

Arm Title

mFOLFIRINOX

Arm Type

Active Comparator

Arm Description

Intervention Type

Radiation

Intervention Name(s)

SBRT+mFOLFIRINOX

Intervention Description

Intervention Type

Drug

Intervention Name(s)

mFOLFIRINOX

Intervention Description

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 Outcome Measure Information:

Title

1-year progression-free survival rate

Description

Proportion of patients without disease progression or death

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Overall survival

Description

Time between randomization and death of any cause

Time Frame

1 year

Title

Progression-free survival

Description

Time between randomization and disease progression or death of any cause

Time Frame

1 year

Title

Overall response rates

Description

Tumor response per Response Evaluation Criteria in Solid Tumors version 1.1

Time Frame

1 year

Title

Adverse events

Description

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

Time Frame

1 year

Title

Surgical resection rate

Description

Proportion of patients who underwent curative-intent surgery

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Changhoon Yoo, MD, PhD

Phone

+82-2-3010-1727

yooc@amc.seoul.kr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Changhoon Yoo, MD, PhD

Organizational Affiliation

Asan Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Asan Medical Center

City

Seoul

ZIP/Postal Code

05505

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Changhoon Yoo, MD

First Name & Middle Initial & Last Name & Degree

Changhoon Yoo, MD

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

27247216

Citation

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.

Results Reference

background

PubMed Identifier

27139057

Citation

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.

Results Reference

background

PubMed Identifier

21969502

Citation

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.

Results Reference

background

PubMed Identifier

29800971

Citation

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. Erratum In: JAMA Oncol. 2018 Oct 1;4(10):1439.

Results Reference

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

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