JCOG1801 is a randomized phase III trial which was initiated in Japan in August 2019 to confirm the superiority of preoperative chemoradiotherapy followed by surgery plus adjuvant chemotherapy for local relapse-free survival over standard treatment, i.e. surgery plus adjuvant chemotherapy, for previously non-irradiated locally recurrent rectal cancer.
Histopathologically proven adenocarcinoma or adenosquamous carcinoma on the resected specimen of the initial rectal cancer or endoscopic biopsy from the initial rectal cancer.
The main tumor location of the initial rectal cancer is upper, middle or lower rectum, or anal canal.
Either of the following treatments was performed for the initial rectal cancer, and classified as R0/1 or ER (Endoscopical R)0/1 on pathological diagnosis.
Patients with distant metastasis during or after treatment for the initial rectal cancer, and radical surgical resection or radical radiotherapy performed more than 168 days before registration is eligible.
Synchronous or metachronous (within 5 years) malignancies except cancer with 5-year relative survival rate of 95% or more such as carcinoma in situ, intramucosal tumor, or early stage cancers.
Infections requiring systemic treatment.
Body temperature higher than 38 degrees Celsius at registration.
Pregnant female, female within 28 days post-parturition, or lactating mother. Men with partners planning conception in the near future.
National Cancer Center Hospital East
Lead sponsor
Japan Clinical Oncology Group
Collaborator
Japan Agency for Medical Research and Development
Collaborator