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Brief Title: Bladder Cancer Chemoradiation Using Intensity Modulated Radiation Therapy
Official Title: Phase II Trial To Evaluate The Potential For Helical Tomotherapy IMRT To Improve Bladder Cancer Chemoradiation
Study ID: NCT00350688
Brief Summary: While the gold standard of treatment in invasive bladder cancer is surgical removal of the bladder, it is well accepted that a reasonable alternative is an organ preserving approach. Bladder preservation can be achieved in patients with radiotherapy alone or together with concurrent chemotherapy. This clinical trial will assess the potential of intensity modulated radiation therapy (IMRT) delivered using helical tomotherapy to reduce radiation-induced gastrointestinal toxicity and increase the accuracy of bladder cancer irradiation.
Detailed Description: Patients opting for bladder conservation in Ottawa are currently treated using intra-arterial cisplatin and concurrent radiotherapy using 3D-Conformal radiotherapy. It has been recently reported that while combination chemotherapy with local therapy (surgery or radiation) does modestly increase survival, greater toxicity results. As a precursor to the integration of gemcitabine in the standard chemotherapy regimen at our centre, the current clinical trial is designed to determine if a novel approach to the delivery of intensity modulated radiotherapy (IMRT), namely Helical Tomotherapy, will decrease the toxicity of standard chemoradiation. Chemoradiation will be administered as follows: 3 courses Intra-Arterial Cisplatin 90mg/m2 every 3 weeks and radical radiation delivered as IMRT for a total dose of 60 Gy in 30 daily fractions of 2 Gy per day M-F starting day 15.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
The Ottawa Hospital Regional Cancer Centre, Ottawa, Ontario, Canada
Name: Libni Eapen, MD
Affiliation: Ottawa Hospital Research Institute
Role: STUDY_DIRECTOR