Treating Locally Advanced Rectal Cancer With TAS-102 Chemotherapy Plus Neoadjuvant Radiotherapy
Recruiting · NCT05965531 · Interventional (participants receive a specific treatment) · Lead sponsor: Sun Yat-sen University
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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
Where it is running
1 location listed.
- Cancer Center, Sun Yat-sen University - Guangzhou, Guangdong, China