3D-Conformal Radiation vs Helical Tomotherapy in Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT00326638|
Recruitment Status : Unknown
Verified September 2016 by Ottawa Hospital Research Institute.
Recruitment status was: Active, not recruiting
First Posted : May 17, 2006
Last Update Posted : September 16, 2016
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Radiation: Arm B: Helical Tomotherapy Intensity Modulated Radiotherapy Other: Arm A: 3D-Conformal Radiation||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||72 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized Phase III Trial of 3D Conformal Radiotherapy Versus Helical Tomotherapy IMRT in High-Risk Prostate Cancer|
|Study Start Date :||March 2005|
|Actual Primary Completion Date :||January 2015|
|Estimated Study Completion Date :||March 2018|
Arm A: 3D-Conformal Radiation
Intervention: Standard radiation treatment for high risk prostate cancer. Once daily Monday to Friday for 8 weeks.
3DCRT 7800 cGY/39 Fractions/ STD Technique*
Other: Arm A: 3D-Conformal Radiation
3DCRT 7800 cGY/39 Fractions/ STD Technique* once daily Monday to Friday for 8 weeks
Other Name: Radiation Therapy
Experimental: Arm B: Helical Tomotherapy Intensity Modulated Radiotherapy
Intervention: Helical Tomotherapy Intensity Modulated Radiotherapy (IMRT) once daily Monday to Friday for 8 weeks.
IMRT using Helical Tomotherapy* 7800 cGY/39 Fractions Boost IMRT to Prostate 3,200 cGy/16
Radiation: Arm B: Helical Tomotherapy Intensity Modulated Radiotherapy
IMRT using Helical Tomotherapy* 7800 cGY/39 Fractions once daily Monday to Friday for 8 weeks
Other Name: IMRT
- Late rectal toxicity from radiotherapy of the prostate [ Time Frame: Month 1, 4, 8, every 4 months during year 1-2, then every 6 months during years 2-5, then every 12 months until disease progression ]Outcome measurements will be determined by physical exam and bloodwork.
- Acute rectal toxicity, Acute and late bladder toxicity, Disease specific survival at 5 years, Biochemical relapse free survival at 5 years, Local control rates at 5 years, Quality of Life [ Time Frame: Month 1, 4, 8, every 4 months during year 1-2, then every 6 months during years 2-5, then every 12 months until disease progression ]Outcome measurements will be determined by physical exam and bloodwork.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00326638
|The Ottawa Hospital Regional Cancer Centre|
|Ottawa, Ontario, Canada, K1H 8L6|
|Study Director:||Shawn Malone, MD||Ottawa Hospital Research Institute|