Rectal cancer Locally advancer rectal cancer
Conditions
Interventions
(1)Neoadjuvant chemoradiation therapy: 1.8Gyx28, Capecitabine 1600mg/m^2/day
(2)Neoadjuvant chemotherapy: CAPOX (Oxaliplatin 130mg/m^2, Capecitabine2000mg/m^2/day, d1-14, 3week)x4cycles
(3)Operation:
Total neoadjuvant therapy (TNT), Surgery, Total mesorectum excision
Sponsors
KAGAWA Yoshinori
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Written informed consent obtained from every patient before enrollment in the study. (2)Patients with rectal adenocarcinoma confirmed by histological examination. (3)Radical resection is clinically possible without findings of any distant metastases. (4)Aged >=20 years. (5)Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1. (6)The lower edge of the tumor is within 12cm of the anal margin (AV). (7)No prior treatment for the tumor. (8)There is no history of radiation therapy to the pelvic area, including the treatment for other types of cancer. (9)Rectal cancer cases with cT3-T4N0M0 or TanyN+M0 at the pretreatment diagnosis. (10)The following criteria should be met for the major organ functions within 14 days before the registration. If there are multiple test results within the relevant period, the one most recent result to the registration will be adopted. The blood transfusion and hematopoietic factor preparations will not be administered within 14 days before the test. a.Neutrophil count>=1,500 cells/mm^3 b.Platelet count>=100,000 cells/mm^3 c.Hemoglobin>=9.0 g/dL d.Total bilirubin=45 mL/min
Exclusion criteria
Exclusion criteria: (1)Patients who received treatment by any of the following within a certain period before the start of the protocol treatment.Extensive surgery within 4 weeks (stoma construction or CV port construction will be excluded). (2)Cases with T4b, levator ani muscle invasion or lateral lymph node positive. (3)Patients with severe pulmonary disease, including interstitial pneumonia, pulmonary fibrosis and severe emphysema. (4)Patients underwent stent to stenosis lesion. (5)Patients with severe comorbidities (heart failure, renal failure, liver failure, hemorrhagic digestive ulcer, intestinal paralysis, intestinal obstruction, uncontrolled diabetes, etc.) (6)Patients with active multiple cancers. Synchronous double cancer and metachronous double cancer within a disease-free interval of 5 years. Lesions consistent with carcinoma in situ or intramucosal carcinoma that have been cured by local treatment are not classified as active multiple cancers. (7)Pregnant women, lactating woman, positive pregnancy tests, or no intention of contraception. (8)Patients with HBsAg or HCVAb positive. (9)Patients with HIV infection. (10)Patients whom a lead investigator or primary physician deems are not appropriate for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response: pCR | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical complete response (cCR) rate: The state of the disappearance on the image is defined as cCR. Radical resection rate. Recurrence form Relapse-free survival (RFS) Overall survival (OS) Protocol treatment completion rate Completion rate of neoadjuvant chemoradiation therapy Completion rate of neoadjuvant chemotherapy Safety 1.Neoadjuvant treatment related adverse event rate judged by CTCAE ver5.0 2.Intraoperative safety evaluation judged by CTCAE ver5.0 3.Postoperative safety evaluation judged by CTCAE ver5.0 and Clavien-Dindo classification | — |
Contacts
Public ContactYoshinori KAGAWA
Osaka International Cancer Institute
Outcome results
None listed