Rectal cancer Rectal cancer
Conditions
Interventions
One week prior to initiating short-term preoperative radiation therapy for rectal cancer, take Shiboreito orally.
C080903
Saireito
Sponsors
Suto Akiko
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who meet all of the following criteria will be eligible for inclusion: 1.Histologically confirmed colorectal cancer (adenocarcinoma). 2.The tumor is located in the RS, Ra, or Rb region. 3.The investigator has determined that the patient is at high risk for local recurrence and is indicated for preoperative radiotherapy. 4.Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0-1. 5.Age>18 years at the time of registration. 6.Adequate preservation of major organ function, and the investigator judges that preoperative radiotherapy and surgery can be safely performed. Major organ function must meet the following criteria: 7.Neutrophil count: >1,500 /mm3 8.Platelet count: >100,000 /mm3 9.Total bilirubin: <1.5 x the institutional upper limit of normal (ULN) 10.AST, ALT, ALP: <2.5 x the institutional ULN 11.Serum creatinine: <1.5 x the institutional ULN 12.The patient has been fully informed about participation in this study using a written informed consent document and has provided written informed consent.
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria will be considered ineligible: 1.Prior chemotherapy for the target disease. 2.Prior radiotherapy to the pelvic region. 3.Known drug hypersensitivity to the investigational study drug(s). 4.History of major surgery within 28 days prior to registration (implantable central venous access port placement and stoma creation are permitted). 5.History of clinically significant severe cardiovascular disease within 6 months prior to registration (including myocardial infarction, unstable angina, heart failure, stroke, pulmonary embolism, or other thromboembolic events). 6.Presence of serious comorbidities (including interstitial pneumonia or pulmonary fibrosis, hepatic failure, or active infection). 7.Any other condition that the investigator judges to be inappropriate for the safe conduct of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence rate of Grade 3 or higher diarrhea occurring within 2 weeks after the initiation of radiotherapy. As described in Section 8.2 (Examination Items and Timing), this will be evaluated using a questionnaire. Grading will be performed in accordance with CTCAE Version 5.0. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.The incidence rate of Grade 1-2 diarrhea occurring within 2 weeks after the initiation of radiotherapy. As described in Section 8.2 (Examination Items and Timing), this will be evaluated using a questionnaire. Grading will be performed in accordance with CTCAE Version 5.0. 2.Completion rate of Shireito administration. As described in Section 8.2 (Examination Items and Timing), this will be evaluated using a medication diary. 3.Positive rate of inflammatory response. Among patients who completed radiotherapy, the proportion of cases in which CRP and IL-6 levels increased compared with pre-Saireito administration will be evaluated. 4.Incidence rate of abdominal pain and anal pain. As described in Section 8.2 (Examination Items and Timing), this will be evaluated using a questionnaire. Pain intensity will be assessed using the VAS. 5.Incidence rate of postoperative high-output stoma in patients who underwent stoma creation. Postoperative stoma output data will be collected from medical records, and the occurrence of high-output stoma will be evaluated. High-output stoma is defined as stoma output of >1,500 mL per 24 hours. 6.Incidence rate of postoperative complications within 90 days after surgery. Information on postoperative complications within 90 days will be collected from medical records, and the incidence rate of Grade 3 or higher complications will be evaluated. Grading will be performed in accordance with the Clavien-Dindo classification, version 2.0. | — |
Contacts
Public ContactAkiko Suto
Hirosaki University Hospital
Outcome results
None listed