Neoadjuvant Radiotherapy for Rectal Adenocarcinoma With Capecitabine Versus TAS-102 (Neo-REACT): A Multi-center, Randomized, Phase III Trial
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
Neoadjuvant fluoropyrimidine-based chemoradiotherapy followed by total mesorectal excision (TME) is the standard of care for locally advanced rectal cancer (LARC); however, pathologic complete response (pCR) rates are low. Trifluridine/tipiracil (TAS-102) is a new oral anti-tumor oral formulation of nucleoside analogue, trifluridine (FTD), and a thymidine phosphorylase inhibitor, tipiracil (TPI). Previous studies have shown that TAS-102 has shown clinically relevant activity after fluoropyrimidine failure in colorectal cancer and may thus be of increased efficacy compared with current standard capecitabine chemoradiation. Also, a phase 2 trials conducted by our team have demonstrated that neoaduvant TAS-102 concurrent with long-course radiotherapy could lead to a high pCR rate of 32% with acceptable toxicity for LARC patients. Herein, we will conduct this multicenter, randomized controlled, phase III trial to explore the safety and efficacy benefit of TAS-102 concurrent with long-course radiotherapy for LARC.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek 18-75 lat
- •Potwierdzony histologicznie rak odbytnicy, stadium II lub III
- •Guz położony nie dalej niż 12 cm od krawędzi odbytu, z co najmniej jednym czynnikiem wysokiego ryzyka
- •Brak innych typów raka odbytnicy lub jednoczesnego raka okrężnicy
- •Mierzalne zmiany nowotworowe
- •Dobry stan ogólny (ECOG 0-1)
- •Oczekiwana długość życia powyżej 6 miesięcy
✗ Disqualifies
- •Określone zmiany genetyczne w komórkach nowotworu (dMMR lub MSI-H)
- •Niewyjaśnione obniżenie liczby komórek krwi
- •Przerzuty na odległość, w tym do węzłów chłonnych pachwiny
- •Aktywna choroba autoimmunologiczna
- •Niekontrolowane problemy sercowe
- •Historia innych nowotworów złośliwych (z wyjątkiem czerniaków i raka szyjki macicy in situ)
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Maximum age
- 75 Years
- Last updated (source)
- October 15, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (1)
Shandong Cancer Hospital and Institute
Jinan, China
Trial contact
Jinbo Yue, Docter
Contact information from ClinicalTrials.gov. Contact in English.
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Data from ClinicalTrials.gov. AI-assisted translation, last sync: 10/16/2026.
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