Bladder Cancer Chemoradiation Using Intensity Modulated Radiation Therapy

Not Applicable

Terminated

• Conditions: Bladder Cancer
• Interventions: Radiation: Helical tomotherapy IMRT

• Registration Number: NCT00350688
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2005-11
• Study First Submitted: 2006-07-07
• Study First Submitted QC: 2006-07-07
• Study First Posted: 2006-07-11
• Primary Completion: 2010-04
• Study Completion: 2010-04
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-15
• Last Update Posted: 2020-04-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Helical tomotherapy IMRT	Helical tomotherapy IMRT	Helical tomotherapy IMRT

Primary Outcome Measures

Name	Time	Method
Acute GI toxicity

Secondary Outcome Measures

Name	Time	Method
Dosimetric evaluation of bowel and pelvic marrow radiation dose, Bladder time organ motion studies, Patterns of recurrence

Trial Locations

Locations (1)

The Ottawa Hospital Regional Cancer Centre; 🇨🇦 Ottawa, Ontario, Canada