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

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Eligibility criteria expanded, about 14 words
  2. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    v6
  3. Study title expanded, about 7 wordsv5
  4. Start date: Apr 30, 2025 to Jul 30, 2025v4 Show 8 more changesShow less
    • Primary endpoints: 2 to 1
    • Trial status: Recruiting to Not Yet Recruiting
    • Enrollment target: 228 to 210
    • Primary completion date: Apr 2027 to Jun 2027
    • Study completion date: Apr 2028 to Jun 2028
    • Eligibility criteria expanded, about 35 words
    • Secondary endpoints: 4 to 3
    • Site details revised
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Apr 2025 to Apr 30, 2025
    • Site details revised
    v3
  6. Start date: Feb 2025 to Apr 2025v2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06850090
Lead Sponsor Shandong Cancer Hospital and Institute
Conditions
(from sponsor)		 Rectal Cancer, Rectal Cancer Patients
Related terms Rectal Neoplasms
Enrollment 210 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov