Neoadjuvant Radiotherapy for Rectal Adenocarcinoma With Capecitabine Versus TAS-102 (Neo-REACT): A Multi-center, Randomized, Phase III 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

Trial Details

NCT ID
NCT06850090
Phase
PHASE3
Sponsor
Shandong Cancer Hospital and Institute
Status
RECRUITING
Cancer Type
Colorectal Cancer
Interventions
  • TAS-102
  • Capecitabine
Locations (sample)
  • Jinan, Shandong, China|36.66833,116.99722

Key Eligibility Criteria

  • Patients aged between 18 and 75 years of either sex.
  • Histologically confirmed rectal adenocarcinoma with the following conditions:
  • Clinical stage II (T3-4, N-) or III (any T, N+) as determined by MRI.
  • The tumor is located within 12 cm from the anal margin, with at least one high-risk factors (ie, extramural vascular invasion \[EMVI+\], mesorectal…

For full eligibility, visit ClinicalTrials.gov.

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