Phase II Trial To Evaluate The Potential For Helical Tomotherapy IMRT To Improve Bladder Cancer Chemoradiation
18 Years
N/A
Both
Bladder Cancer
Trial Information
Phase II Trial To Evaluate The Potential For Helical Tomotherapy IMRT To Improve Bladder Cancer Chemoradiation
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Acute GI toxicity
Principal Investigator
Libni Eapen, MD
Investigator Role:
Study Director
Investigator Affiliation:
Ottawa Hospital Research Institute
Authority:
Canada: Health Canada
Study ID:
2005407-01H
NCT ID:
NCT00350688
Start Date:
November 2005
Completion Date:
April 2010
Related Keywords:
- Bladder Cancer
- Bladder,
- Cancer,
- Chemoradiation,
- IMRT,
- tomotherapy
- Urinary Bladder Neoplasms
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