Rectal cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) Histologically proven as adenocarcinomas 2) clinical stage II or III 3) 1) Tumor located below the peritoneum. 4) Aged between 20 and 80 years old 5) ECOG Performance status of 0 or 1 6) no severe comobidity or organ disorder 7) willing to provide written informed consent
Exclusion criteria
Exclusion criteria: 1) History of severe drug hypersensitivity 2) history of another malignancy within 5 years 3) Severe concurrent disease such as poorly controlled hypertension, poorly controlled diabetes, interstitial pneumonia or pulmonary fibrosis, severe chronic pulmonary emphysema, heart failure, renal failure, hepatic failure. 4) Pregnant females, possibly pregnant females, females wishing to become pregnant and nursing mothers. Males who are currently attempting to produce a pregnancy 5) Physician concludes that the patient's participation in this trial is inappropriate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Accuracy of sentinel node metastases | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)Sensitivity 2)Specificity 3)Positive Predictive Value(PPV) 4)Negative Predictive Value(NPV) 5)Detection rate 6)Adverse event rate | — |
Countries
Japan
Contacts
Yokohama City University Medical Center Gastroenerological Center