A phase II study of preoperative concurrent chemoradiation therapy for patients with locally advanced rectal cance
- Conditions
- rectal cancer
- Registration Number
- JPRN-UMIN000004104
- Lead Sponsor
- Hamamatsu University School of Medicine, Second department of Surgery
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 30
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method