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Recruiting Phase 3

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

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About this study

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.

Condition
Rectal Cancer, Rectal Cancer Patients
Tested
TAS-102, Capecitabine
Sponsor
Shandong Cancer Hospital and Institute

Who can join

Age
18 to 75 years
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 11

  • Minimum age: 18 years
  • Maximum age: 75 years
  • Study condition: Rectal Cancer, Rectal Cancer Patients
  • Patients aged between 18 and 75 years of either sex.
  • Histologically confirmed rectal adenocarcinoma with the following conditions:
  • Clinical stage II (T3-4, N-) or III (any T, N+) as determined by MRI.
  • 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 \[≤5 cm from the anal verge\]).
  • No other types of rectal cancer (e.g., sarcoma, lymphoma, carcinoid, squamous cell carcinoma) or synchronous colon cancer.
  • Presence of measurable lesions that meet RECIST v1.1 criteria for evaluation.
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
  • Estimated life expectancy \> 6 months.

Exclusion 6

  • Patients of dMMR or MSI-H status.
  • Unexplained myelosuppression.
  • 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.
  • Active autoimmune disease or history of autoimmune disease.
  • Uncontrolled cardiac symptoms or diseases.
  • History of other malignancies, except for cured basal cell carcinoma of the skin and cervical carcinoma in situ.

Where

1 site, 1 recruiting

Shandong Cancer Hospital and Institute

Jinan, Shandong, China

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.