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Bladder Cancer Chemoradiation Using Intensity Modulated Radiation Therapy

This study has been terminated.
(More advanced treatments superceded study design)
Sponsor:
Information provided by (Responsible Party):
Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT00350688
First received: July 7, 2006
Last updated: July 11, 2012
Last verified: July 2007
History of Changes
  Purpose

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 Intervention Phase
Bladder Cancer
 Radiation: Helical tomotherapy IMRT
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial To Evaluate The Potential For Helical Tomotherapy IMRT To Improve Bladder Cancer Chemoradiation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ottawa Hospital Research Institute:

Primary Outcome Measures:
  • Acute GI toxicity

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

Enrollment: 9
Study Start Date: November 2005
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Radiation: Helical tomotherapy IMRT
    Helical tomotherapy IMRT
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00350688

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

No publications provided

Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT00350688     History of Changes
Other Study ID Numbers: 2005407-01H, OTT 05-03
Study First Received: July 7, 2006
Last Updated: July 11, 2012
Health Authority: Canada: Health Canada

Keywords provided by Ottawa Hospital Research Institute:
Bladder,
Cancer,
Chemoradiation,
IMRT,
tomotherapy

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

ClinicalTrials.gov processed this record on May 16, 2013