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Recruitment Status : Terminated (More advanced treatments superceded study design)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

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.

Condition or disease Intervention/treatment Phase
Bladder Cancer Radiation: Helical tomotherapy IMRT Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial To Evaluate The Potential For Helical Tomotherapy IMRT To Improve Bladder Cancer Chemoradiation
Study Start Date : November 2005
Actual Primary Completion Date : April 2010
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

Intervention Details:
  • Radiation: Helical tomotherapy IMRT
    Helical tomotherapy IMRT

Primary Outcome Measures :
  1. Acute GI toxicity

Secondary Outcome Measures :
  1. Dosimetric evaluation of bowel and pelvic marrow radiation dose, Bladder time organ motion studies, Patterns of recurrence

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00350688

Canada, Ontario
The Ottawa Hospital Regional Cancer Centre
Ottawa, Ontario, Canada, K1H 8L6
Sponsors and Collaborators
Ottawa Hospital Research Institute
Study Director: Libni Eapen, MD Ottawa Hospital Research Institute

Responsible Party: Ottawa Hospital Research Institute Identifier: NCT00350688     History of Changes
Other Study ID Numbers: 2005407-01H
OTT 05-03
First Posted: July 11, 2006    Key Record Dates
Last Update Posted: July 13, 2012
Last Verified: July 2007

Keywords provided by Ottawa Hospital Research Institute:

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urologic Diseases