NIPH Clinical Trials Search

JRCT ID: jRCTs011220019

Registered date:27/09/2022

Exploratory research investigating the impact of the total neoaduvant therapy for locally advanced rectal cancer.

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedRectal cancer
Date of first enrollment27/09/2022
Target sample size55
Countries of recruitment
Study typeInterventional
Intervention(s)Intervention of the preoperative chemotherapy (three courses of CapeOX) in localy advanced rectal cancer after the preoperative chemoradiotherapy


Primary OutcomeThe rate of complete respose after the neoaduvant therapy (pathological CR+clinical CR)
Secondary Outcome1) Safety, completion rate, response rate of the neoadjuvant therapy (including clinical complete response), postoperative 30-day complication rate, rate of R0 resection and positive CRM rate 2) Prognosis in eligible cases and that in cases without protocol diviation (overall survival, disease free survival, 3-year cumaltive local recurrence rate) 3) Prognosis after the surgical resecton (overall survival, disease free survival, 3-year cumultive local recurrence rate; overall survival, disease free survival, 3-year cumultive local recurrence rate in each stage) 4) Prognosis after the watch and wait strategy (overall survival, disease free survival, 3-year cumultive local recurrence rate, rate of salvage surgery, disease free survival after the salvage surgery, 3-year cumultive local recurrence rate after the salvage surgery) 5) QOL regarding life satisfaction, peripheral neurological disorder and incontinence, cumaltive rate of stoma, postoperative 3-year complication rate in anastomosis

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximumNot applicable
Include criteria1. The cases histologically diagnosed as rectal adenocarcinoma by endoscopic biopsy. 2. clinical stage II-III by preoperative imaging. 3. The main occupation of the primary tumor site is located middle and lower rectum. (within 12 cm from anal verge) 4. The age is 20 years old and older and under 75 years old. 5. Performance Status(ECOG) is 0 or 1. 6. No history of surgical treatment for primary tumor. 7. Cases without a history of chemotherapy and radiation. 8. Cases of major organ function is maintained. 9. Cases of childbearing potential must consent to the contraception (female, from the consent to 7 weeks after the last chemotherapy; male, from the consent to 15 weeks after the last chemotherapy). 10. Cases with written informed concent.
Exclude criteria1. Double cancer 2. Pregnant or lactating women. 3. Cases with a history of colorectal cancer (Excluding mucosal cancer). 4. Cases with peripheral sensory neuropathy(CTCAE v5.0 Grade 1 or more). 5. Cases with infectious disease requiring systemic therapy. 6. Cases with uncontrolable cardiovascular disease. 7. Cases with a history of mental disorder. 8. HBs-Ag positive, HIV1-Ab positive, HIV2-Ab positive, HTLV1-Ab positive, HCV-Ab positive, HBc-Ab positive with HBV-DNA positive, or HBs-Ab positive with HBV-DNA positive 9. Cases whom the investigators judged as inappropreate for some reasons

Related Information


Public contact
Name Shigenori Homma
Address N-15, W-7, Kita-ku, Sapporo 060-8638 Hokkaido Japan 060-8638
Telephone +81-11-706-5927
Affiliation Graduate School of Medicine, Hokkaido University
Scientific contact
Name Akinobu Taketomi
Address N-14, W-5, Kita-ku, Sapporo 060-8648 Hokkaido Japan 060-8648
Telephone +81-11-716-1161
Affiliation Hokkaido University Hospital