Neoadjuvant treatment for rectal cancer using TAS-102 or capecitabine

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

This study is testing if a new oral cancer medication called TAS-102 works better than the standard treatment, capecitabine, for people with locally advanced rectal cancer before surgery.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 210 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Shandong Cancer Hospital and Institute (Academic / other)
• Locations: 1 site (Jinan, Shandong)
• Trial ID: NCT06850090 on ClinicalTrials.gov

What this trial studies

This phase III trial aims to compare the efficacy and safety of TAS-102, a new oral anti-tumor agent, with the standard treatment of capecitabine in patients with locally advanced rectal cancer. Participants will receive neoadjuvant chemoradiotherapy followed by total mesorectal excision. The study seeks to improve the low rates of pathologic complete response observed with current therapies. By evaluating the outcomes of both treatment regimens, the trial hopes to identify a more effective approach for enhancing tumor response and preserving anal function.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with histologically confirmed rectal adenocarcinoma at clinical stage II or III.

Not a fit: Patients with distant metastasis, certain genetic markers like dMMR or MSI-H status, or active autoimmune diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this trial could lead to improved treatment outcomes and higher rates of tumor response in rectal cancer patients.

How similar studies have performed: Previous studies have shown promising results with TAS-102, indicating potential for success in this novel approach.

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, 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.

Where this trial is running

Jinan, Shandong

• Shandong Cancer Hospital and Institute — Jinan, Shandong, China (Recruiting)

Study contacts

• Principal investigator: Jinbo Yue, Docter — Shandong Cancer Hospital and Institute
• Study coordinator: Jinbo Yue, Docter

Conditions Rectal Cancer; Rectal Cancer Patients