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Sponsored by: |
Ottawa Health Research Institute |
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Information provided by: | Ottawa Health Research Institute |
ClinicalTrials.gov Identifier: | NCT00326638 |
In this study we are comparing two forms of radiotherapy. This study is being done because it is not clear at present time whether intensity modulated radiotherapy (IMRT) can reduce side effects of radiotherapy compared to standard radiotherapy (called 3D-Conformal Radiotherapy).
Condition | Intervention | Phase |
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Prostate Cancer |
Procedure: Helical tomotherapy IMRT |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Randomized Phase III Trial of 3D Conformal Radiotherapy Versus Helical Tomotherapy IMRT in High-Risk Prostate Cancer |
Estimated Enrollment: | 72 |
Study Start Date: | November 2005 |
Estimated Study Completion Date: | May 2014 |
Radical radiation therapy plays an important role in the management of prostate cancer, yielding comparable long-term outcomes to surgery. Unfortunately, long term disease free survival data using PSA criteria have shown that less than 50% of high-risk patients are free of disease at 10 years. To improve on the results of conventional dose radiotherapy dose escalation with three-dimensional conformal radiation has been employed. Due to the irregular shape of the prostate and the variable motion of this organ there is substantial radiation of adjacent normal surrounding tissue during treatment which results in radiation-induced toxicity. Intensity-modulated radiation therapy (IMRT) is a new form of radiation therapy. Preliminary evidence suggests that IMRT improves the dose distribution during radiation therapy of the prostate. The hypothesis of this study is that IMRT delivered using Helical Tomotherapy can reduce late toxicity of radical radiotherapy as compared to three-dimensional conformal radiation (3DCRT) in high-risk prostate cancer patients.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Presence of any of the following high risk features:
Exclusion Criteria:
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: Shawn Malone, MD |
Study Director: | Shawn Malone, MD | Ottawa Health Research Institute |
Study ID Numbers: | 2005242-01H, OTT 05-02 |
Study First Received: | May 15, 2006 |
Last Updated: | July 25, 2007 |
ClinicalTrials.gov Identifier: | NCT00326638 |
Health Authority: | Canada: Health Canada |
prostate, IMRT, tomotherapy, radiation, cancer |
Prostatic Diseases Genital Neoplasms, Male Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms |
Neoplasms Neoplasms by Site |