A Multicenter Single-arm P2 to Evaluate Safety and Efficacy of the Total Neoadjuvant Therapy for cT2 Rectal Cancer
Trial Parameters
Brief Summary
A multicenter single-arm phase 2 study to evaluate safety and efficacy of the total neoadjuvant therapy of short course radiation therapy followed by neoadjuvant oxaliplatin/fluorouracil-based chemotherapy (CAPOX) for cT2 rectal cancer
Eligibility Criteria
Inclusion Criteria: * 1\. The patient has been fully informed of the contents of the study and has given written consent. 2\. The patient has adenocarcinoma of the rectum confirmed by histological examination. 3\. No distant metastases are detected on imaging studies, and radical resection is clinically feasible. 4\. Age of 20 years or older on the date of consent. 5. ECOG Performance Status (PS) is 0 - 1 (PS 0 for age 71 years or older on the date of consent). 6\. Previously untreated rectal cancer with the lower margin of the tumor within 12 cm of the anal verge (AV). 7\. Patients with cT2N0M0 in the diagnosis before starting treatment (a lymph node with a short diameter of 7 mm or more is considered positive). The conditions for lymph node metastasis shall be as follows. Contrast-enhanced CT or MRI (plain or contrast-enhanced) with a slice width of 5 mm or less. (i) Short diameter of 10 mm or more (ii) Short diameter of 7 mm or more and one or more of the following a) to c) are met