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Trifluridine/tipiracil plus bevacizumab for third-line management of metastatic colorectal cancer: SUNLIGHT study design.
- Source :
-
Future oncology (London, England) [Future Oncol] 2021 Jun; Vol. 17 (16), pp. 1977-1985. Date of Electronic Publication: 2021 Feb 11. - Publication Year :
- 2021
-
Abstract
- Trifluridine/tipiracil (FTD/TPI) is an orally active formulation of trifluridine, a thymidine-based nucleoside analog, and tipiracil hydrochloride, a thymidine phosphorylase inhibitor that increases the bioavailability of trifluridine. Preliminary studies of FTD/TPI plus bevacizumab have produced encouraging results in the treatment of refractory metastatic colorectal cancer. Here, we describe the design of the multinational Phase III SUNLIGHT, an open-label study of FTD/TPI plus bevacizumab as third-line treatment for patients with unresectable metastatic colorectal cancer. A total of 490 patients will be randomized 1:1 to receive either FTD/TPI plus bevacizumab, or FTD/TPI monotherapy. The primary objective is to significantly improve overall survival with FTD/TPI plus bevacizumab compared with FTD/TPI monotherapy. The first patient was enrolled in November 2020.
- Subjects :
- Adult
Aged
Aged, 80 and over
Bevacizumab administration & dosage
Clinical Trials, Phase III as Topic
Colorectal Neoplasms metabolism
Colorectal Neoplasms pathology
Drug Combinations
Female
Humans
Male
Middle Aged
Multicenter Studies as Topic
Neoplasm Metastasis
Pyrrolidines administration & dosage
Randomized Controlled Trials as Topic
Thymine administration & dosage
Trifluridine administration & dosage
Young Adult
Antineoplastic Combined Chemotherapy Protocols therapeutic use
Colorectal Neoplasms drug therapy
Subjects
Details
- Language :
- English
- ISSN :
- 1744-8301
- Volume :
- 17
- Issue :
- 16
- Database :
- MEDLINE
- Journal :
- Future oncology (London, England)
- Publication Type :
- Academic Journal
- Accession number :
- 33569986
- Full Text :
- https://doi.org/10.2217/fon-2020-1238