Trial Parameters
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 radio