Article ; Online: Stereotactic body radiotherapy plus rucosopasem in locally advanced or borderline resectable pancreatic cancer: GRECO-2 phase II study design.
Future oncology (London, England)
2024 Volume 20, Issue 8, Page(s) 437–446
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 ...
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. |
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MeSH term(s) | Humans ; Adenocarcinoma ; Clinical Trials, Phase II as Topic ; Dose Fractionation, Radiation ; Multicenter Studies as Topic ; Pancreatic Neoplasms/diagnosis ; Pancreatic Neoplasms/radiotherapy ; Pancreatic Neoplasms/drug therapy ; Radiosurgery/adverse effects ; Randomized Controlled Trials as Topic |
Language | English |
Publishing date | 2024-01-24 |
Publishing country | England |
Document type | Clinical Trial Protocol ; Journal Article |
ZDB-ID | 2274956-1 |
ISSN | 1744-8301 ; 1479-6694 |
ISSN (online) | 1744-8301 |
ISSN | 1479-6694 |
DOI | 10.2217/fon-2022-1219 |
Database | MEDical Literature Analysis and Retrieval System OnLINE |
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