locally advanced rectal cancer (T3-4, N0-2, M0)
Conditions
Interventions
S-1: 80mg/m2/day, 2 weeks administration followed by 1 week withdrawl and 2 weeks administration, for a total of 5 weeks. Radiationa therapy: 1.8 Gy/day, 5 days/week (through Monday to Friday), a tot
Sponsors
Department of Surgery, Miyagi Cancer Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Pathologically diagnosed as adenocarcinoma. 2) Patients who satisfy the following criteria within 28 days before registration: * Patients with tumors in T3-4 and N0-2 according to the Japanese Classification of Colorectal Carcinoma, the 2nd edition and resectable. * The tumor is mainly located in Ra, Rb or P according to the Japanese Classification of Colorectal Carcinoma, the 2nd edition. * The anal margin of the tumor is lower than the level of peritoneal inversion. * The tumor is not macroscopically classified into type 4. * Diagnosed with colonoscopy, barium enema, contrast CT and contrast MRI. If the patient is allergic to contrast, plain CT and MRI are allowed. * The distance between anal verge and the lower margin of the tumor should be recorded. 3) patients should be free from liver metastasis, peritoneal dissemination or distant metastasis. 4) Between 20 years old and 80 years old when registered. 5) Performance Status (ECOG) is 0-1. 6) No prior radiotherapy, chemotherapy or hormone therapy. 7) No severe disorder of bone marrow, heart, lung, liver or kidney. The data of blood test within 14 days before registration should be within the following range: WBC counts: 12,000/mm3 > and > 3,000 /mm3 Neutrophil counts: > 1,500 / mm3 Platelet counts: > 75,000 /mm3 Hemoglobin: > 9.0 g/dl Total bilirubin: 1.5 mg/dl > AST (GOT), ALT (GPT): 80 IU/L > Serum creatinine: 1.5 mg/dL > Creatinine clearance: > 50 ml/min (with Cockcroft-Gault's formula) 8) No clinically abnormal finding of ECG within 28 days before registration 9) Patients who can eat food and can be orally administered. 10) Informed consent has been acquired.
Exclusion criteria
Exclusion criteria: 1) Patients with past history of severe drug allergy. 2) Patients with active cancers in other organs or multicentric cancers in colorectum. 3) Contraindication of S-1 administration. 4) Patients who suffered from infection with fever higher than 38 degree. 5) Patients with severe complications such as bowel obstruction, ileus, intestinal pneumonitis or pulmonary fibrosis, uncontrolled diabetes, uncontrolled hypertension, heart failure, renal failure, liver dysfunction and others. 6) Patients with past history of intestinal pneumonitis. 7) Patients with pleural or ascites retention which should be treated. 8) Patients with fresh bleeding from intestinal tract. 9) Patients with watery diarrhea. 10) Women who are willing to pregnancy or possible to be pregnant. Patients who do not intend to prevent pregnancy. 11) Patients who are continuing steroid administration orally or intravenously. 12) Patients with HBs positive. 13) Patients whom doctors consider not to be eligible for this study for some other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety (incidence and grades of adverse events for preoperative chemoradiation therapy) | — |
Secondary
| Measure | Time frame |
|---|---|
| RFS, OS, accumulated local recurrence rate, treatment completion rate, R0 resection rate, down-stagingrate, pathological response rate, response rate (RECIST version1.1), pCR, nutritional assessment, immunohistochemical assessment, safety (operative complications, late adverse events). | — |
Countries
Japan
Contacts
Public ContactKoh Miura
Miyagi Cancer Center Department of Surgery
Outcome results
None listed