Bladder Cancer Chemoradiation Using Intensity Modulated Radiation Therapy

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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00350688

Enrollment

Registered

2006-07-11

Start date

2005-11-30

Completion date

2010-04-30

Last updated

2020-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder Cancer

Keywords

Bladder,, Cancer,, Chemoradiation,, IMRT,, tomotherapy

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.

Interventions

RADIATIONHelical tomotherapy IMRT

Helical tomotherapy IMRT

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Acute GI toxicity	—

Secondary

Measure	Time frame
Dosimetric evaluation of bowel and pelvic marrow radiation dose, Bladder time organ motion studies, Patterns of recurrence	—

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026