Clinical trial NCT00350688: Bladder Cancer Chemoradiation Using Intensity Modulated Radiation Therapy
Official title: Phase II Trial To Evaluate The Potential For Helical Tomotherapy IMRT To Improve Bladder Cancer Chemoradiation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Bladder Cancer
Keywords: Bladder,
Cancer,
Chemoradiation,
IMRT,
tomotherapy
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
First posted: 2006-07-11
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Acute GI toxicity
Secondary outcomes:
measure: Dosimetric evaluation of bowel and pelvic marrow radiation dose, Bladder time organ motion studies, Patterns of recurrence
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The Ottawa Hospital Regional Cancer Centre
state: Ontario
Study officials:
affiliation: Ottawa Hospital Research Institute
name: Libni Eapen, MD
role: STUDY_DIRECTOR
References: