Stereotactic body radiotherapy plus rucosopasem in locally advanced or borderline resectable pancreatic cancer: GRECO-2 phase II study design

Sarah E Hoffe; Todd A Aguilera; Parag J Parikh; Maged M Ghaly; Joseph M Herman; Joseph M Caster; Dae Won Kim; James Costello; Mokenge P Malafa; Elizabeth C Moser; Eugene P Kennedy; Kara Terry; Michael Kurman

doi:10.2217/fon-2022-1219

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Stereotactic body radiotherapy plus rucosopasem in locally advanced or borderline resectable pancreatic cancer: GRECO-2 phase II study design

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Stereotactic body radiotherapy plus rucosopasem in locally advanced or borderline resectable pancreatic cancer: GRECO-2 phase II study design

Sarah E Hoffe, Todd A Aguilera, Parag J Parikh, Maged M Ghaly, Joseph M Herman, Joseph M Caster, Dae Won Kim, James Costello, Mokenge P Malafa, Elizabeth C Moser, …

Future oncology (London, England), Vol.20(8), pp.437-446

03/2024

DOI: 10.2217/fon-2022-1219

PMCID: PMC10988540

PMID: 38264869

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Abstract

Ablative doses of stereotactic body radiotherapy (SBRT) may improve pancreatic cancer outcomes but may carry greater potential for gastrointestinal toxicity. Rucosopasem, an investigational selective dismutase mimetic that converts superoxide to hydrogen peroxide, can potentially increase tumor control of SBRT without compromising safety. GRECO-2 is a phase II, multicenter, randomized, double-blind, placebo-controlled trial of rucosopasem in combination with SBRT in locally advanced or borderline resectable pancreatic cancer. Patients will be randomized to rucosopasem 100 mg or placebo via intravenous infusion over 15 min, before each SBRT fraction (5 × 10 Gy). The primary end point is overall survival. Secondary end points include progression-free survival, locoregional control, time to metastasis, surgical resection rate, best overall response, in-field local response and acute and long-term toxicity.

Pancreatic Cancer

superoxide dismutase mimetic

stereotactic body radiation therapy

rucosopasem

Details

Title: Subtitle: Stereotactic body radiotherapy plus rucosopasem in locally advanced or borderline resectable pancreatic cancer: GRECO-2 phase II study design
Creators: Sarah E Hoffe - Moffitt Cancer Center
Todd A Aguilera - The University of Texas Southwestern Medical Center
Parag J Parikh - Henry Ford Hospital
Maged M Ghaly - Northwell Health
Joseph M Herman - Northwell Health
Joseph M Caster - University of Iowa
Dae Won Kim - Moffitt Cancer Center
James Costello - Moffitt Cancer Center
Mokenge P Malafa - Moffitt Cancer Center
Elizabeth C Moser - Galera Therapeutics, Inc., Malvern, PA 19355, USA
Eugene P Kennedy - Galera Therapeutics, Inc., Malvern, PA 19355, USA
Kara Terry - Galera Therapeutics, Inc., Malvern, PA 19355, USA
Michael Kurman - Galera Therapeutics, Inc., Malvern, PA 19355, USA
Resource Type: Journal article
Publication Details: Future oncology (London, England), Vol.20(8), pp.437-446
DOI: 10.2217/fon-2022-1219
PMID: 38264869
PMCID: PMC10988540
NLM abbreviation: Future Oncol
eISSN: 1744-8301
Grant note: Galera Therapeutics, Inc.
Language: English
Electronic publication date: 01/24/2024
Date published: 03/2024
Academic Unit: Radiation Oncology
Record Identifier: 9984548664902771

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