Status:
TERMINATED
Budesonide Foam Versus Placebo for Prevention of Acute Radiation Proctitis
Lead Sponsor:
Dr. Falk Pharma GmbH
Conditions:
Radiation Proctitis
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
To proof the superiority of an 8-week rectal treatment with once-daily 2 mg budesonide versus placebo for the prevention of acute radiation proctitis, and to evaluate the occurrence of chronic radiati...
Eligibility Criteria
Inclusion
- Signed informed consent,
- Men aged at least 18 years,
- Patients with ECOG performance status \<= 2 or Karnofsky Performance Status Scale \>= 70%,
- Estimated life expectancy more than 3 years,
- Diagnosis of prostate carcinoma,
- Indication for local RT in patients with prostatic cancer.
Exclusion
- Crohn's disease, indeterminate colitis, ulcerative colitis, microscopic colitis (i.e., collagenous colitis and lymphocytic colitis),
- Severe or symptomatic ischaemic colitis at baseline,
- Grade III internal haemorrhoids at baseline,
- High risk patients needing extended radiation therapy,
- Acute EORTC/RTOG lower GI toxicity score of \>=1 at baseline,
- Bacterial, amoebic, fungal, or viral infections of the gut,
- Tuberculosis, hypertension, infection, diabetes mellitus (included familiarly predisposition), active peptic ulcer, osteoporosis, glaucoma, or cataract, if careful medical monitoring is not ensured,
- Portal hypertension or liver cirrhosis,
- Abnormal hepatic function (ALT, AST or AP \> 2.5 x ULN),
- Known intolerance/hypersensitivity/resistance to study drug or drugs of similar chemical structure or pharmacological profile, or to any of the other constituents of the study drug,
- Participation in another clinical trial within the last 30 days, simultaneous participation in another clinical trial, or previous participation in this trial
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT00828230
Start Date
September 1 2008
End Date
October 1 2011
Last Update
January 30 2012
Active Locations (3)
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1
Klinik für Radioonkologie und Strahlentherapie - Klinikum Braunschweig
Braunschweig, Germany, 38114
2
Strahlentherapie, St. Vincentius-Kliniken gAG
Karlsruhe, Germany, 76135
3
Strahlentherapie, Klinikum Mutterhaus der Borromäerinnen
Trier, Germany, 54290