Bladder Cancer Chemoradiation Using Intensity Modulated Radiation Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00350688
Recruitment Status : Terminated (More advanced treatments superceded study design)
First Posted : July 11, 2006
Last Update Posted : July 13, 2012
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

July 7, 2006
July 11, 2006
July 13, 2012
November 2005
April 2010   (Final data collection date for primary outcome measure)
Acute GI toxicity
Same as current
Complete list of historical versions of study NCT00350688 on Archive Site
Dosimetric evaluation of bowel and pelvic marrow radiation dose, Bladder time organ motion studies, Patterns of recurrence
Same as current
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Bladder Cancer Chemoradiation Using Intensity Modulated Radiation Therapy
Phase II Trial To Evaluate The Potential For Helical Tomotherapy IMRT To Improve Bladder Cancer Chemoradiation
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.
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.
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Bladder Cancer
Radiation: Helical tomotherapy IMRT
Helical tomotherapy IMRT
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
April 2010
April 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. A pathological diagnosis of pure or predominantly transitional cell bladder carcinoma
  2. Adequate Hematology and biochemistry parameters
  3. Invasive or treatment refractory non-invasive transitional cell bladder carcinoma OR operable patients who prefer bladder preservation OR inoperable patients.
  4. No metastases on CT scan of chest

Exclusion Criteria:

  1. Patient with contraindication to radical radiotherapy including inflammatory bowel disease or significant irritative bladder symptoms
  2. Contraindication to internal iliac arterial catheterization
  3. Prior pelvic radiotherapy for other malignancies
  4. Prior cytotoxic chemotherapy excepting intravesical agents
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
OTT 05-03
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Ottawa Hospital Research Institute
Ottawa Hospital Research Institute
Not Provided
Study Director: Libni Eapen, MD Ottawa Hospital Research Institute
Ottawa Hospital Research Institute
July 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP