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

被引：1

作者：

Hoffe, Sarah E. ^{[1
]}

Aguilera, Todd A. ^{[2
]}

Parikh, Parag J. ^{[3
]}

Ghaly, Maged M. ^{[4
]}

Herman, Joseph M. ^{[4
]}

Caster, Joseph M. ^{[5
]}

Kim, Dae Won ^{[1
]}

Costello, James ^{[1
]}

Malafa, Mokenge P. ^{[1
]}

Moser, Elizabeth C. ^{[6
]}

Kennedy, Eugene P. ^{[6
]}

Terry, Kara ^{[6
]}

Kurman, Michael ^{[6
]}

机构：

[1] H Lee Moffitt Canc Ctr & Res Inst, Tampa, FL 33612 USA

[2] UT Southwestern Med Ctr, Dallas, TX 75390 USA

[3] Henry Ford Canc Inst, Detroit, MI 48202 USA

[4] Northwell Hlth Canc Inst, New Hyde Pk, NY 11040 USA

[5] Univ Iowa Hosp & Clin, Iowa City, IA 52242 USA

[6] Galera Therapeut Inc, Malvern, PA USA

来源：

FUTURE ONCOLOGY | 2024年 / 20卷 / 08期

关键词：

pancreatic cancer; rucosopasem; stereotactic body radiation therapy; superoxide dismutase mimetic; RADIATION-THERAPY; INDUCTION CHEMOTHERAPY; GEMCITABINE; ERLOTINIB; SURVIVAL; OUTCOMES;

D O I：

10.2217/fon-2022-1219

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

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 x 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. The use of high doses of radiation delivered directly to tumors (stereotactic body radiation therapy [SBRT]) may improve survival compared with lower doses of radiation in patients with pancreatic cancer, but it may increase side effects. Rucosopasem, an investigational new drug being developed, can potentially improve the ability of SBRT to treat tumors without decreasing safety. In a previous study, median overall survival was improved when patients were treated with SBRT plus avasopasem, a drug that works the same way as rucosopasem. GRECO-2 is a clinical trial of rucosopasem used in combination with SBRT for treatment of localized pancreatic cancer. Patients will be randomly selected to receive either rucosopasem 100 mg or placebo via intravenous infusion over 15 min, before each SBRT treatment. The main result being studied is overall survival. Additional results include amount of time before tumors start to grow, how often patients get tumors surgically removed, best overall response and long-term safety.Clinical Trial Registration: NCT04698915 (ClinicalTrials.gov)

引用

页码：437 / 446

页数：10