aburen enema for prevention of radiation proctitis. A multicentre randomised placebo-controlled dose-finding phase II study to evaluate efficacy, tolerability, acceptability and compliance with enema in patients undergoing radical radiotherapy for prostate cancer - Naburen Enema for prevention of radiation proctitis
- Conditions
- Radiation ProctitisMedDRA version: 8.1Level: LLTClassification code 10036774Term: Proctitis
- Registration Number
- EUCTR2006-000329-78-IT
- Lead Sponsor
- PROMEFARM
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- Not specified
Clinically localized prostate cancer with indication for radical CRT Histologically-confirmed adenocarcinoma of the prostate
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Total dose 70 Gy ICRU Life expectancy 5 years Serious systemic disease insulin treated diabetes mellitus etc Serious colonic disease inflammatory bowel disease Patients undergoing pelvic radiation Prior chemotherapy or pelvic radiation Distant metastases M0 Psychiatric illness Major rectal surgery Major ano-rectal disease eg, anal and rectal cancer Active anal fissures Ano-rectal fistulae Patients with previous anal sphincterotomy
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method