Neoadjuvant Radiotherapy for Rectal Adenocarcinoma With Capecitabine Versus TAS-102 (Neo-REACT): A Multi-center, Randomized, Phase III Trial
Recruiting
Phase 3
Interventional Study
Rectal Cancer
Rectal Cancer Patients
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 75
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 210 (estimated)
- Sponsor
- Shandong Cancer Hospital and Institute · Other
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About This 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). …
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Patients aged between 18 and 75 years of either sex.
2. Histologically confirmed rectal adenocarcinoma with the following conditions:
1. Clinical stage II (T3-4, N-) or III (any T, N+) as determined by MRI.
2. The tumor is located within 12 cm from the anal margin, wit…
Contacts