Locally advanced rectal cancer
Conditions
Interventions
Intensity-modulated radiotherapy (1.8 Gy/fr, 45-50.4Gy), Capecitabine 1650 mg/m2/day oral administration on the day of radiotherapy.
Sponsors
Kyoto University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically confirmed rectal adenocarcinoma 2) Following three criteria was met, i) Palpable by digital examination or within 12 cm from anal verge ii) Positive circumferential resection margin or clinical T3-4N0 or T1-4N1-2 iii) No peritoneal, hepatic and lung metastasis 3) >=20 years old 4) Performance Status 0-2 5) No history of pelvic radiotherapy 6) Adequate organ function Neutrophil count >= 1500/mm3 Platelet count >=100 000/mm3 Total bilirubin <=1.5 ULN Both serum aspartate aminotransferase and alanine aminotransferase <=100 IU/L CCr >= 30 ml/min/body 7) Able to intake orally 8) Grade 0-1 diarrhea 9) Written consent to participate in the current trial
Exclusion criteria
Exclusion criteria: 1) Uncontrollable comorbidity (diarrhea, interstitial pneumonia, collagen vascular disease,diabetes mellitus, heart failure etc) 2) Pregnant or child-bearing potential, lactating patients 3) History of hypersensitivity to capecitabine or 5-fluorouracil 4) Currently taking tegafur/Gimeracil/Oteracil or within 7 days after discontinuation 5) Considered to be difficult to participate the current trial from psychotic disorders
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Grade 2 Acute diarrhea | — |
Countries
Japan
Contacts
Public ContactKatsuyuki Sakanaka
Kyoto University Graduate School and Faculty of Medicine Department of Radiation Oncology and Image-applied Therapy
Outcome results
None listed