| Autor: |
Hoffe SE; H. Lee Moffitt Cancer Center & Research Institute, Tampa, FL 33612, USA., Aguilera TA; UT Southwestern Medical Center, Dallas, TX 75390, USA., Parikh PJ; Henry Ford Cancer Institute, Detroit, MI 48202, USA., Ghaly MM; Northwell Health Cancer Institute, New Hyde Park, NY 11040, USA., Herman JM; Northwell Health Cancer Institute, New Hyde Park, NY 11040, USA., Caster JM; Universty of Iowa Hospitals & Clinics, Iowa City, IA 52242, USA., Kim DW; H. Lee Moffitt Cancer Center & Research Institute, Tampa, FL 33612, USA., Costello J; H. Lee Moffitt Cancer Center & Research Institute, Tampa, FL 33612, USA., Malafa MP; H. Lee Moffitt Cancer Center & Research Institute, Tampa, FL 33612, USA., Moser EC; Galera Therapeutics, Inc., Malvern, PA 19355, USA., Kennedy EP; Galera Therapeutics, Inc., Malvern, PA 19355, USA., Terry K; Galera Therapeutics, Inc., Malvern, PA 19355, USA., Kurman M; Galera Therapeutics, Inc., Malvern, PA 19355, USA. |
| Abstrakt: |
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. |
