A phase II study of preoperative concurrent chemoradiation therapy for patients with locally advanced rectal cance - Study of preoperative concurrent XELOX and radiation therapy for patients with locally advanced rectal cancer

Hamamatsu University School of Medicine, Second department of Surgery0 sites30 target enrollmentOctober 1, 2010

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: rectal cancer
Sponsor: Hamamatsu University School of Medicine, Second department of Surgery
Enrollment: 30
Status: Recruiting
Last Updated: 2 years ago

No summary available.

Registry

who.int

Start Date

October 1, 2010

End Date

November 1, 2014

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

Hamamatsu University School of Medicine, Second department of Surgery

•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