Bladder Cancer Chemoradiation Using Intensity Modulated Radiation Therapy

NCT00350688 | Terminated

• 2 other identifiers: 2005407-01HOTT 05-03
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Bladder Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Acute GI toxicity

Secondary Outcomes (1)

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

Study Arms (1)

Helical tomotherapy IMRT

OTHER

Helical tomotherapy IMRT

Radiation: Helical tomotherapy IMRT

Interventions

Helical tomotherapy IMRT RADIATION

Helical tomotherapy IMRT

Helical tomotherapy IMRT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

Study Sites (1)

The Ottawa Hospital Regional Cancer Centre

Ottawa, Ontario, K1H 8L6, Canada

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Libni Eapen, MD

  Ottawa Hospital Research Institute

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2006
• First Posted: July 11, 2006
• Study Start: November 1, 2005
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: April 17, 2020

Record last verified: 2020-04

Locations

CA (1)