Actively Recruiting
Neoadjuvant Radiotherapy for Rectal Adenocarcinoma With Capecitabine Versus TAS-102 (Neo-REACT): A Multi-center, Randomized, Phase III Trial
Led by Shandong Cancer Hospital and Institute ยท Updated on 2026-04-28
210
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a multicenter, randomized, phase III trial to assess a new treatment approach for locally advanced rectal cancer (LARC). The study compares neoadjuvant chemoradiotherapy using a standard oral drug, capecitabine, with a newer oral formulation called TAS-102 combined with radiotherapy. This research aims to improve the rate of complete tumor response before surgery, as current treatments have limited success in achieving full tumor disappearance. The trial involves two groups receiving long-course radiotherapy alongside chemotherapy. One group receives TAS-102 at specific doses during radiotherapy weeks and additional chemotherapy cycles with oxaliplatin and TAS-102 before surgery. The other group receives capecitabine during radiotherapy and chemotherapy cycles with oxaliplatin and capecitabine before surgery. Surgery follows total mesorectal excision principles, and postoperative adjuvant therapy includes two cycles of CapeOX chemotherapy. Participants will be monitored for tumor response, side effects, and survival outcomes over several years. Key assessments include measuring complete response rate at one year, tracking severe adverse reactions, and evaluating recurrence-free and overall survival at three years. The study includes thorough imaging, clinical evaluations, and laboratory tests to assess treatment effects and safety, with participation lasting throughout treatment and follow-up periods.
CONDITIONS
Brief Title
Neoadjuvant Radiotherapy for Rectal Adenocarcinoma With Capecitabine Versus TAS-102 (Neo-REACT): A Multi-center, Randomized, Phase III Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged between 18 and 75 years of either sex
- Histologically confirmed rectal adenocarcinoma at clinical stage II (T3-4, N-) or III (any T, N+) as determined by MRI
- Tumor located within 12 cm from the anal margin with at least one high-risk factor (extramural vascular invasion, mesorectal fascia involvement, cT4, cN2, lateral lymph nodes, tumor deposit, or tumor in lower rectum 4 cm from anal verge)
- No other types of rectal cancer or synchronous colon cancer
- Presence of measurable lesions meeting RECIST v1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Estimated life expectancy greater than 6 months
You will not qualify if you...
- Patients with dMMR or MSI-H status
- Unexplained myelosuppression
- Evidence of distant metastasis or inguinal lymph node metastasis
- Active autoimmune disease or history of autoimmune disease
- Uncontrolled cardiac symptoms or diseases
- History of other malignancies except cured basal cell carcinoma of the skin and cervical carcinoma in situ
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 5 to 17 weeks
Participants receive neoadjuvant long-course radiotherapy combined with either TAS-102 or capecitabine chemotherapy. Radiotherapy is delivered over 5 weeks with concurrent chemotherapy. This is followed by intermittent consolidation chemotherapy cycles before surgery.
Weekly visits during 5 weeks of radiotherapy and additional visits for consolidation chemotherapy cycles
Duration - 1 day
Participants undergo total mesorectal excision (TME) surgery to remove the tumor after neoadjuvant treatment.
1 in-person surgical visit
Duration - Approximately 6 weeks
Participants receive two cycles of CapeOX chemotherapy as postoperative adjuvant treatment.
Visits for two chemotherapy cycles spaced 3 weeks apart
Trial Site Locations
Total: 1 location
1
Shandong Cancer Hospital and Institute
Jinan, Shandong, China
Actively Recruiting
Research Team
J
Jinbo Yue, Docter
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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