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

RecruitingPhase 3Ages 18 Years - 75 YearsAllShandong Cancer Hospital and Institute
NCT06850090 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 controll

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📋 Eligibility rules (as published)
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, with at least one high-risk factors (ie, extramural vascular invasion \[EMVI+\], mesorectal fascia involved \[MRF+\], cT4, cN2, lateral lymph nodes, tumor deposit, or tumor located in the lower rectum \[≤5 cm from the anal verge\]). 3. No other types of rectal cancer (e.g., sarcoma, lymphoma, carcinoid, squamous cell carcinoma) or synchronous colon cancer. 4. Presence of measurable lesions that meet RECIST v1.1 criteria for evaluation. 5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1. 6. Estimated life expectancy \> 6 months. Exclusion Criteria: 1. Patients of dMMR or MSI-H status. 2. Unexplained myelosuppression. 3. Evidence of distant metastasis and inguinal lymph node metastasis based on comprehensive chest and abdominal CT or whole-body PET-CT scans. Retroperitoneal lymph nodes above the iliac vessel bifurcation are considered distant metastasis. 4. Active autoimmune disease or history of autoimmune disease. 5. Uncontrolled cardiac symptoms or diseases. 6. History of other malignancies, except for cured basal cell carcinoma of the skin and cervical carcinoma in situ.
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What it tests

  • TAS-102
  • Capecitabine
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Where

1 site
Shandong Cancer Hospital and Institute
Jinan, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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