rectal cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) Rectal cancer 2) Local resection is performed within 12 weeks before registration day. 3) En bloc resection and margins negative 4) Histopathologically, the lesion is pSM cancer and it satisfies any one or more of the following conditions. 1. poorly differentiated adenocarcinoma 2. depth of submucosal invasion more than 1mm 3. lymphovascular invasion positive 4. budding Grade 2,3 5) No lymph node metastases and distant metastasis in diagnostic imaging within 16 weeks before registration 6) Rejection of the surgery 7) ECOG Performance Status PS:0,1 8) No history of the chemotherapy and radiotherapy 10) Blood data 1. WBC>3000/mm3 2. Hb>9.0g/dL 3. Plt>100,000/mm3 4. AST,ALT<100 IU/L 5. t-bil<2.0mg/dL 6. Cr<1.5mg/dL 11) Agreement from the patients
Exclusion criteria
Exclusion criteria: 1)Presence of synchronous or metachronous advanced colorectal cancer and malignant diseases in any other organs 2)Pregnant woman 3)Patients with psychosis 4)Use of the phenytoin and warfarin potassium 5)Use of steroids 6)Activity of hepatitis B or hepatitis C 7)Systemic infection 8)Others
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The rate of treatment completion | — |
Countries
Japan
Contacts
National Cancer Center Hospital East Department of Gastroenterology & Gastrointestinal Oncology