Bladder Cancer Chemoradiation Using Intensity Modulated Radiation Therapy - Full Text View

Sponsored by:	Ottawa Health Research Institute
Information provided by:	Ottawa Health Research Institute
ClinicalTrials.gov Identifier:	NCT00350688

Purpose

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.

Condition	Intervention	Phase
Bladder Cancer	Procedure: Helical tomotherapy IMRT	Phase II

Genetics Home Reference related topics: bladder cancer

MedlinePlus related topics: Bladder Cancer Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase II Trial To Evaluate The Potential For Helical Tomotherapy IMRT To Improve Bladder Cancer Chemoradiation

Further study details as provided by Ottawa Health Research Institute:

Primary Outcome Measures:

Acute GI toxicity

Secondary Outcome Measures:

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

Estimated Enrollment:	15
Study Start Date:	November 2005
Estimated Study Completion Date:	July 2008

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

A pathological diagnosis of pure or predominantly transitional cell bladder carcinoma
Adequate Hematology and biochemistry parameters
Invasive or treatment refractory non-invasive transitional cell bladder carcinoma OR operable patients who prefer bladder preservation OR inoperable patients.
No metastases on CT scan of chest

Exclusion Criteria:

Patient with contraindication to radical radiotherapy including inflammatory bowel disease or significant irritative bladder symptoms
Contraindication to internal iliac arterial catheterization
Prior pelvic radiotherapy for other malignancies
Prior cytotoxic chemotherapy excepting intravesical agents

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00350688

Locations

Canada, Ontario
The Ottawa Hospital Regional Cancer Centre	Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Contact: Scott Grimes 613-737-7700 ext 70523 sgrimes@ohri.ca
Contact: Lorraine Millar 613-737-7700 ext 70306 lmillar@ohri.ca
Principal Investigator: Libni Eapen, MD
Sub-Investigator: Robert MacRae, MD

Sponsors and Collaborators

Ottawa Health Research Institute

Investigators

Study Director:

Libni Eapen, MD

Ottawa Health Research Institute

More Information

Study ID Numbers:	2005407-01H, OTT 05-03
Study First Received:	July 7, 2006
Last Updated:	July 25, 2007
ClinicalTrials.gov Identifier:	NCT00350688
Health Authority:	Canada: Health Canada

Keywords provided by Ottawa Health Research Institute:

Bladder,
Cancer,
Chemoradiation,
IMRT,
tomotherapy

Study placed in the following topic categories:

Cystocele
Urologic Diseases
Urinary Bladder Diseases
Urinary Bladder Neoplasms

Urogenital Neoplasms
Urologic Neoplasms
Urinary tract neoplasm
Bladder neoplasm

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 14, 2009