Tests short radiotherapy followed by chemotherapy before surgery for rectal cancer
Tests radiation followed by chemotherapy before surgery in adults with rectal cancer.
Plain-language title generated from the registry record
Registry title: Total Neoadjuvant Therapy in Rectal Cancer
Key facts
- Where
- Tainan, TaiwanSee the site
- Phase
- Phase 2
Where in Taiwan
- National Cheng Kung University HospitalTainan, TaiwanTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- National Cheng-Kung University Hospital
- Trial code
- NCT06162650
- Record updated
- 8 April 2026
- Original description
In this phase 2 study, the efficacy of total neoadjuvant therapy in Taiwanese patients with rectal cancer will be investigated. Patients with stage II or III middle/low rectal cancer will be prospective enrolled. The total neoadjuvant therapy with the short-course radiotherapy (5×5 Gy over a maximum of 8 days) followed by chemotherapy with mFOLFOX6 for 9 cycles will be administered. The primary endpoint is the complete response (CR) rate which will take into account the patients with clinical and pathological complete response.Read full original descriptionShow less
A Phase II Study of Total Neoadjuvant Therapy in Rectal Cancer
In this phase 2 study, the efficacy of total neoadjuvant therapy in Taiwanese patients with rectal cancer will be investigated. Patients with stage II or III middle/low rectal cancer will be prospective enrolled. The total neoadjuvant therapy with the short-course radiotherapy (5×5 Gy over a maximum of 8 days) followed by chemotherapy with mFOLFOX6 for 9 cycles will be administered. The primary endpoint is the complete response (CR) rate which will take into account the patients with clinical and pathological complete response.
Inclusion: Histologically confirmed diagnosis of adenocarcinoma of the rectum; Tumors located at mid or low rectum (distal extension less than 10 cm from the anal verge); Clinical stage II or III (T3/4 and/or N+; no distant metastasis); No prior chemotherapy, radiotherapy or surgery for rectal cancer; Age ≥20; ECOG 0-1; Adequate organ function, including followings:; ANC ≥1,500/μL; Hb ≥8.0 gm/dL; Platelet 100,000/mm3; Total bilirubin ≤1.5x upper normal limit; AST ≤3x upper normal limit; ALT ≤3x upper normal limit; Creatinine ≤1.5x upper normal limit; Ability to understand and the willingness to sing a written informed consent.
Exclusion: Patients who have received prior pelvic radiotherapy; Patients with any other concurrent medical or psychiatric condition or disease which, in the investigator's judgement, would make them inappropriate candidates for entry into this study; Patients receiving other anticancer or experimental therapy; Recurrent rectal cancer; Patients who have concomitant malignancies, except for adequately treated basal cell carcinoma of the skin or in situ carcinoma of the cervix. Subjects who have prior malignancies and have been disease-free for more than 5 years can be enrolled; Patients with active infection requiring intravenous antibiotic treatment; Patients with a history of any arterial thrombotic event within the past 6 months, including unstable angina, myocardial infarction (MI) or cerebrovascular accident (CVA), New York Hear Association (NYHA) grade II or greater congestive heart failure, or uncontrolled cardiac arrhythmia; Known DPD deficiency or hypersensitivity to oxaliplatin; Women who are pregnant or breastfeeding. Women of childbearing potential who are unwilling or unable to use an acceptable method of birth control to avoid pregnancy for the entire study period; Any contraindications to MRI.