Actively Recruiting
Total Neoadjuvant Therapy in Rectal Cancer
Led by National Cheng-Kung University Hospital · Updated on 2026-04-08
42
Participants Needed
1
Research Sites
365 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Total Neoadjuvant Therapy in Rectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
Inclusion Criteria:
- 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 criteria
- 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 who have received prior pelvic radiotherapy;
- 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;
- 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;
- 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;
- Patients receiving other anticancer or experimental therapy;
- Known DPD deficiency or hypersensitivity to oxaliplatin;
- Any contraindications to MRI.
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
National Cheng Kung University Hospital
Tainan, Taiwan, 704
Actively Recruiting
Research Team
Y
Yu-Min Yeh, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here