However, results were mainly based on clinical assessments while concomitant
endoscopic and histopathologic features of the radiation-induced damage in bowel mucosa were not described [6–10]. The aim of this study was to assess the efficacy of subcutaneous amifostine in preventing radiation colitis in patients irradiated for pelvic neoplasms, by combining clinical, endoscopic and histopathologic data. Methods Study and Patients This randomised phase II exploratory clinical trial was activated in May 2001 and conducted in an Academic Hospital learn more [University General Hospital]. The procedures followed were in accordance with the Helsinki Declaration (1964, amended in 1975, 1983, 1989, 1996 and 2000) of the World Medical Association. Institutional review boards and the ethics committee of our University Hospital approved the trial protocol with and patient informed consent. Patients with pelvic malignancies were considered for participation into this trial if they fulfilled a list of eligibility criteria [see below] Caspase Inhibitor VI and signed an informed consent. Enrolled patients were randomly assigned to receive daily amifostine (subcutaneously, 500 mg flat dose) before radiotherapy (A) or radiotherapy alone (R). Sigmoidoscopy and blinded biopsies were scheduled
for all patients prior to initiation of treatment and twice following completion of radiotherapy. Study endpoints The primary study endpoint was to determine the efficacy of amifostine in preventing radiation-induced colitis (RC) by using combined clinical, endoscopic and histopathologic data from patients irradiated to the pelvis. The secondary endpoints of the study were the assessment of agreement between clinical, endoscopic and histopathologic data during radiotherapy and post-radiotherapy period and the evaluation of amifostine-related toxicity. Eligibility Carnitine palmitoyltransferase II criteria The study enrolled patients with primary pelvic or metastatic
to the pelvis malignancies who were referred for adjuvant, radical or palliative radiotherapy but not for re-irradiation. All patients recruited in the study were older than 18 years, had a World Health Organization (WHO) performance status 0-2 and a life expectancy of more than 6 months. Pregnant or lactating women, patients with severe infections or severe psychiatric or neurologic illnesses were excluded. Patients with decreased hematologic AZD1080 reserves, with major organ failure, severe electrolyte or metabolic abnormalities were also excluded. In patients with haemoglobin levels below 11 g/dl before radiotherapy, subcutaneous erythropoietin was administered. Patients with hypertension controlled with medication were eligible for amifostine administration. Patients with asymptomatic low blood pressure were included. Patients with symptomatic hypotension were excluded.