Stereotactic body radiotherapy plus rucosopasem in locally advanced or borderline resectable pancreatic cancer: GRECO-2 phase II study design
Recommended Citation
Hoffe SE, Aguilera TA, Parikh PJ, Ghaly MM, Herman JM, Caster JM, Kim DW, Costello J, Malafa MP, Moser EC, Kennedy EP, Terry K, and Kurman M. Stereotactic body radiotherapy plus rucosopasem in locally advanced or borderline resectable pancreatic cancer: GRECO-2 phase II study design. Future Oncol 2024; 20(8):437-446.
Document Type
Article
Publication Date
3-1-2024
Publication Title
Future Oncol
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.
Medical Subject Headings
Humans; Adenocarcinoma; Clinical Trials, Phase II as Topic; Dose Fractionation, Radiation; Multicenter Studies as Topic; Pancreatic Neoplasms; Radiosurgery; Randomized Controlled Trials as Topic
PubMed ID
38264869
ePublication
ePub ahead of print
Volume
20
Issue
8
First Page
437
Last Page
446
