NCT06162650 Total Neoadjuvant Therapy in Rectal Cancer
| NCT ID | NCT06162650 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | National Cheng-Kung University Hospital |
| Condition | Rectal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 42 participants |
| Start Date | 2023-11-16 |
| Primary Completion | 2026-11-16 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 42 participants in total. It began in 2023-11-16 with a primary completion date of 2026-11-16.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
Yu-Min Yeh, MD
PRINCIPAL INVESTIGATOR
National Cheng-Kung University Hospital
Frequently Asked Questions
Who can join the NCT06162650 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, studying Rectal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06162650 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06162650 currently recruiting?
Yes, NCT06162650 is actively recruiting participants. Contact the research team at i5485111@gmail.com for enrollment information.
Where is the NCT06162650 trial being conducted?
This trial is being conducted at Tainan, Taiwan.
Who is sponsoring the NCT06162650 clinical trial?
NCT06162650 is sponsored by National Cheng-Kung University Hospital. The principal investigator is Yu-Min Yeh, MD at National Cheng-Kung University Hospital. The trial plans to enroll 42 participants.
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