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

Pancreatic Adenocarcinoma Clinical Trial

— SABER  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04986930
• Other study ID #: SABER
• Status: Recruiting
• Phase: Phase 2
• Start date: August 14, 2021
• Est. completion date: August 14, 2025

Study information

• Verified date: July 2023
• Source: Asan Medical Center
• Contact: Changhoon Yoo, MD, PhD
• Phone: +82-2-3010-1727
• Email: yooc[@]amc.seoul.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 92
• Est. completion date: August 14, 2025
• Est. primary completion date: August 14, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Pancreatic Adenocarcinoma
• Pancreatic Cancer Non-resectable

Intervention

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

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

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1-year progression-free survival rate	Proportion of patients without disease progression or death	1 year
Secondary	Overall survival	Time between randomization and death of any cause	1 year
Secondary	Progression-free survival	Time between randomization and disease progression or death of any cause	1 year
Secondary	Overall response rates	Tumor response per Response Evaluation Criteria in Solid Tumors version 1.1	1 year
Secondary	Adverse events	Any unintended events graded per National Cancer Institute Common Terminology Criteria for Adverse Events version 5	1 year
Secondary	Surgical resection rate	Proportion of patients who underwent curative-intent surgery	1 year