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Treating Locally Advanced Rectal Cancer With TAS-102 Chemotherapy Plus Neoadjuvant Radiotherapy

RecruitingPhase 2Ages 18 Years - 70 YearsAllSun Yat-sen University
NCT05965531 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The goal of this Phase 2 trial is to evaluate a neoadjuvant treatment mode for locally advanced rectal cancer (LARC), consisting of radiotherapy and concurrent Trifluridine/Tipiracil (TAS-102). The main questions it aims to answer are: (i) whether TAS-102 is effective in treating LARC, when combined with radiotherapy; (ii) whether TAS-102 is safe in combination with radiotherapy. Participants will receive one cycle of TAS-102 chemotherapy and neoadjuvant radiotherapy based on intensity-modulated technique. Then the ones with a possibility of R0 resection will receive radical surgery followed by 6 cycles of adjuvant XELOX (capecitabine plus oxaliplatin) chemotherapy.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Pathologically diagnosed rectal adenocarcinoma via biopsy * Pretreatment clinical TNM stage as T3-4N0M0 or T1-4N1-2M0 (UICC TNM staging classification, version 8) * Tumor with proficient DNA mismatch repair confirmed by immunohistochemical analysis * Age between 18 and 75 years old * Karnofsky performance score ≥ 70 * Distance from tumor lower margin to anal verge \< 12 cm Exclusion Criteria: * Inguinal lymph node metastasis * Multiple primary colorectal cancer * Complete obstruction or perforation * Uncontrolled tuberculosis, AIDS or mental diseases * Severe cardiac, renal, hepatic or hematopoietic dysfunctions unsuitable for chemotherapy or radiotherapy * Prior history of other malignancies with 5 years, except cured cervical carcinoma in situ and skin basal cell carcinoma * Prior history of rectal surgery, pelvic radiotherapy or chemotherapy * Pregnant or lactating women * Other situations for which the investigators consider a patient inappropriate to participate
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What it tests

  • Trifluridine/Tipiracil
  • intensity-modulated radiotherapy
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Where

1 site
Cancer Center, Sun Yat-sen University
Guangzhou, 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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