Bladder Cancer Chemoradiation Using Intensity Modulated Radiation Therapy

Bladder Cancer Clinical Trial

Official title:

Phase II Trial To Evaluate The Potential For Helical Tomotherapy IMRT To Improve Bladder Cancer Chemoradiation

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00350688
• Other study ID #: 2005407-01H
• Secondary ID: OTT 05-03
• Status: Terminated
• Phase: N/A
• Start date: November 2005
• Est. completion date: April 2010

Study information

• Verified date: April 2020
• Source: Ottawa Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Radiation:
• Helical tomotherapy IMRT
Helical tomotherapy IMRT

Locations

Country	Name	City	State
Canada	The Ottawa Hospital Regional Cancer Centre	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute GI toxicity
Secondary	Dosimetric evaluation of bowel and pelvic marrow radiation dose, Bladder time organ motion studies, Patterns of recurrence