rectal cancer
Conditions
Interventions
1)Capecitabine at a dose of 2,000mg/m2/day orally in 2 divided doses for 2weeks on and 1week rest 2) tri-Weekly oxaliplatin at a dose of 130mg/m2 intravenously 3) Radiotherapy is delivered a tota
Sponsors
Hamamatsu University School of Medicine, Second department of Surgery
Iwata city hospital and Fujinomiya city general hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Histologically confirmed Rectum cancer 2. Preoperative findings T2-T4 by endscopic 3.Lower tumor margin is below at the Rb 4.Without prior anti-cancer therapy (chemotherapy,radiation therapy and endocrine therapy) 5. Over 20years old at IC 6. ECOG PS: 0 or 1 6. With or without target lesion by RECIST 7. Alife expectancy greater than 3 months 8.Adequate oral intake 9.Written IC 10. Adequate organ function within the last 14days
Exclusion criteria
Exclusion criteria: 1. Prior or synchronous invasive malignancy unless disease free for a minimum of 5 years 2.Need to drain malignant coelomic fluid 3.Patients with infection requiring antibiotics and/or antifungal agents 4.Existing fever above 38 degrees centigrade 5.Severe comorbidity (ie, bowel paralysis, bowel obstruction, interstitial pneumotitis, pulmonary fibrosis, heart failure, renal failure and hepatic failure) 6.Previous history of severe drug-induced allergy caused by capecitabine and/or oxaliplatin 7.History of the adverse events related to dihydropyrimidine dehydrogenase deficiency against fluorinated pyrimidines 8.Evidence of uncontrolled diarrhea 9.Evidence of diabetic mellitus which uncontrolled or treated with administration of insulin 10.Evidence of fistula 11.With distant metastases (M1) 12.Evidence of psychiatric disability interfering with enrollment to clinical trial 13.Need systemic administration of corticosteroids 14.Pregnant or lactating women, women who are capable of pregnancy or intend to get pregnant 15.Patients judged inappropriate for this study by the physicians
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological Complete Response Rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Relapse Free Survival, Overall Survival, Overall Response Rate, Early Complications, late Complications, Evaluation of safety | — |
Countries
Japan
Contacts
Public ContactToshio Nakamura
Hamamatsu University School of Medicine Second department of Surgery
Outcome results
None listed