drugset / Trial / NCT04177602
Evaluating Trifluridine/Tipiracil Based Chemoradiation in Locally Advanced Rectal Cancer - The Phase I/II TARC Trial
Phase 1/2
Terminated
10 enrolled
University Medical Center Hamburg-Eppendorf
Clinical Trial Center North (CTC North GmbH & Co. KG) · collabServier Affaires Médicales · collab
RandomizedSequentialSingle-blindTreatment
Summary
Seamless phase I/II trial with phase I part for determination of maximum tolerated dose (MTD) of Trifluridine/tipiracil, followed by a randomized phase II trial (randomization ratio 2:1) with an experimental arm with Trifluridine/tipiracil based chemoradiotherapy (CRT) and a standard - calibration arm (internal control) with capecitabine CRT flanked by translational research in patients with locally advanced rectal cancer
Timeline
- Start
- 2019-11-04
- Primary completion
- 2022-09-02
- Completion
- 2022-09-02
Publications
- Thiele B, Stein A, Schultheiss C, Paschold L, Jonas H, Goekkurt E, Russel J, Schuch G, Wierecky J, Sinn M, Tintelnot J, Petersen C, Rothkamm K, Vettorazzi E, Binder M. Trifluridine/Tipiracil Based Chemoradiation in locally Advanced Rectal Cancer: The Phase I/II TARC Trial. Clin Colorectal Cancer. 2025 Mar;24(1):11-17. doi: 10.1016/j.clcc.2024.06.003. Epub 2024 Jun 22.
- Rothkamm K, Christiansen S, Rieckmann T, Horn M, Frenzel T, Brinker A, Schumacher U, Stein A, Petersen C, Burdak-Rothkamm S. Radiosensitisation and enhanced tumour growth delay of colorectal cancer cells by sustained treatment with trifluridine/tipiracil and X-rays. Cancer Lett. 2020 Nov 28;493:179-188. doi: 10.1016/j.canlet.2020.08.038. Epub 2020 Sep 4.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Capecitabine | Small molecule | — | — |
| Subject | Tipiracil | Small molecule | — | — |
| Subject | Trifluridine | Small molecule | — | — |
Indications
No indication recorded.