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

NCT04986930 | Active Not Recruiting Phase 2

• 1 other identifier: SABER
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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

Conditions

Pancreatic Adenocarcinoma; Pancreatic Cancer Non-resectable

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 1-year progression-free survival rate

  Proportion of patients without disease progression or death

  1 year

Secondary Outcomes (5)

• Overall survival

  1 year

• Progression-free survival

  1 year

• Overall response rates

  1 year

• Adverse events

  1 year

• Surgical resection rate

  1 year

Study Arms (2)

SBRT+mFOLFIRINOX

EXPERIMENTAL

* 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

mFOLFIRINOX

ACTIVE 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

Drug: mFOLFIRINOX

Interventions

SBRT+mFOLFIRINOX RADIATION

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

SBRT+mFOLFIRINOX

mFOLFIRINOX DRUG

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

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Asan Medical Center

Seoul, 05505, South Korea

Location

Related 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.

  PMID: 27247216 BACKGROUND

• 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.

  PMID: 27139057 BACKGROUND

• 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.

  PMID: 21969502 BACKGROUND

• 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.

  PMID: 29800971 BACKGROUND

Study Officials

• Changhoon Yoo, MD, PhD

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 27, 2021
• First Posted: August 3, 2021
• Study Start: August 14, 2021
• Primary Completion: January 23, 2025
• Study Completion: December 14, 2025
• Last Updated: January 28, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)