Budesonide Foam Versus Placebo for Prevention of Acute Radiation Proctitis

Condition(s) targeted: Radiation Proctitis

Intervention: budesonide (Drug); Placebo foam (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Dr. Falk Pharma GmbH

Official(s) and/or principal investigator(s):
Ralph Mueller, Dr, Study Director, Affiliation: Dr. Falk Pharma GmbH

Overall contact:
Wolfgang Hoffmann, Prof Dr med, Phone: ++49-(0)531-595-3371, Email: w.hoffmann@klinikum-braunschweig.de

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 radiation proctitis 1 year after start of radiation therapy.

Official title: Randomised, Double-blind, Placebo-controlled, Multicentre, Comparative Phase II Pilot Study on the Efficacy and Tolerability of an 8-week Rectal Treatment With 2 mg Budesonide or Placebo for the Prevention of Acute Radiation Proctitis

Study design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Primary outcome: Proportion of patients developing radiation proctitis during treatment or need rescue medication

Secondary outcome:

Time to occurrence of acute radiation proctitis

Time to occurrence of chronic radiation proctitis

Adverse Events (AEs)

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Male.

Criteria:

Inclusion Criteria:

- 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 Criteria:

- 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

Wolfgang Hoffmann, Prof Dr med, Phone: ++49-(0)531-595-3371, Email: w.hoffmann@klinikum-braunschweig.de

Klinik für Radioonkologie und Strahlentherapie - Klinikum Braunschweig, Braunschweig 38114, Germany; Recruiting
Wolfgang Hoffmann, Prof. Dr. med., Phone: ++49-(0)531-595-3371, Email: w.hoffmann@klinikum-braunschweig.de
Martina Becker-Schiebe, PD Dr. med., Phone: ++49-(0)531 595 3323, Email: m.schiebe@klinikum-braunschweig.de
Wolfgang Hoffmann, Prof Dr med, Principal Investigator
Martina Becker-Schiebe, PD Dr med, Sub-Investigator

Strahlentherapie, Klinikum Mutterhaus der Borromäerinnen, Trier 54290, Germany; Recruiting
Wolfgang Dornoff, Dr. med., Phone: +49-651-947-2350, Email: dornoff@mutterhaus.de
Wolfgang Dornoff, Dr. med., Principal Investigator

Strahlentherapie, St. Vincentius-Kliniken gAG, Karlsruhe 76135, Germany; Recruiting
Johannes Claßen, PD Dr. med., Phone: +49-721-8108-5151, Email: johannes.classen@vincentius-ka.de
Johannes Claßen, PD Dr. med., Principal Investigator

Starting date: September 2008
Ending date: March 2011
Last updated: July 24, 2009