Rectal cancer local advanced rectal cancer, total neoadjuvant therapy, radiation therapy, chemotherapy, surgery
Conditions
Interventions
Sponsors
Kagawa Yoshinori
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Written informed consent obtained 2)Histological diagnosis of primary colorectal adenocarcinoma. 3)No distance metastases with CT or PET 4)Age >= 20 year old. 5)ECOG 0 or 1. If Age >= 75 year old, ECOG 0. 6)Treatment-naive patients with rectal cancer and clinically resectable rectal cancer located within 12cm from their anal verge. 7)Clinical stage of cT3-4 N0 M0 or TanyN+M0 8)Sufficient organ functions
Exclusion criteria
Exclusion criteria: 1. Received one of the following treatments, a. Extensive surgery within 4 weeks (excluding CV port) b. Any anti-cancer drug treatment within 4 weeks c. Irradiation within 4 weeks 2. Have a complication or history of severe lung disease (interstitial pneumonia, pulmonary fibrosis, severe emphysema, etc.). 3. Cases with a colon stent for stenosis 4. Cases with serious comorbidities (heart failure, renal failure, liver failure, hemorrhagic peptic ulcer, intestinal paralysis, intestinal obstruction, uncontrolled diabetes, etc.) 5. Cases with active multiple cancers (simultaneous multiple cancers or metachronous multiple cancers with a disease-free period of 5 years or less). However, cancer in situ (carcinoma in situ) or lesions equivalent to intramucosal cancer that are cured by local treatment are not considered to be active multiple cancers. 6. Pregnant women, lactating women, positive pregnancy tests, or no intention of contraception. 7. Have Hbs antigen positive or HCV antibody positive 8. Have a known human immunodeficiency virus (HIV) infection. 9. In addition, the investigator or research coordinator judges that it is inappropriate 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 disappearance on the image is defined as cCR) Radical resection rate Recurrence type Relapse-free survival (RFS) Overall survival (OS) Preoperative treatment-related adverse event occurrence rate judged by CTCAE ver4.0 Protocol treatment completion rate Radiation therapy completion rate Chemotherapy completion rate Intraoperative safety evaluation (intraoperative complications judged by CTCAE ver4.0) Postoperative safety evaluation (postoperative complications judged by CTCAE ver4.0 and Clavien-Dindo classification) | — |
Contacts
Public ContactKagawa Yoshinori
Osaka International Cancer Institute
Outcome results
None listed