The Role of Tomotherapy in Hypofractionated/Dose Escalated Conformal Radiation Treatment for High Risk Prostate Cancer
This study is ongoing, but not recruiting participants.
Sponsor:
Alberta Health Services
Information provided by (Responsible Party):
Alberta Health Services
ClinicalTrials.gov Identifier:
NCT00126802
First received: August 3, 2005
Last updated: April 9, 2012
Last verified: April 2012
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | August 3, 2005 | ||||
| Last Updated Date | April 9, 2012 | ||||
| Start Date ICMJE | April 2005 | ||||
| Estimated Primary Completion Date | March 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Rectal Toxicity [ Time Frame: 5 weeks ] [ Designated as safety issue: Yes ] Determine the acute and late rectal toxicity of high-dose short-course hypofractionated radiotherapy in five weeks in the treatment of high rish prostate cancer. |
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| Original Primary Outcome Measures ICMJE |
-rectal toxicity | ||||
| Change History | Complete list of historical versions of study NCT00126802 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
prostate-specific antigen (PSA) and MRSI disease control [ Time Frame: 3 years ] [ Designated as safety issue: Yes ] Determine the biochemical control (freedom from PSA failure) rate, overall and disease free survival. |
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| Original Secondary Outcome Measures ICMJE |
-PSA and MRSI disease control | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | The Role of Tomotherapy in Hypofractionated/Dose Escalated Conformal Radiation Treatment for High Risk Prostate Cancer | ||||
| Official Title ICMJE | The Role of Tomotherapy (Dynamic IMRT and Megavoltage CT Scanning) in Hypofractionated/Dose Escalated Conformal Radiation Treatment Using Magnetic Resonance Spectroscopy (MRS) Scans to Predict and Document the Pattern of Local Failure for High Risk Prostate Cancer | ||||
| Brief Summary | Helical tomotherapy is being used to treat the prostate gland, local rates of spread and regional lymph nodes whilst sparing gross structures. The radiation to the gross disease in the prostate is hypofractionated and dose escalated. Magnetic resonance spectroscopic imaging (MRSI) is incorporated into pre- and post-treatment evaluation. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 1 Phase 2 |
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| Study Design ICMJE | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Prostate Cancer | ||||
| Intervention ICMJE | Procedure: Tomotherapy
Standard 45 Gy in 25 fractions in 5 weeks |
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| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Enrollment ICMJE | 60 | ||||
| Estimated Completion Date | March 2013 | ||||
| Estimated Primary Completion Date | March 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Male | ||||
| Ages | up to 75 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Canada | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00126802 | ||||
| Other Study ID Numbers ICMJE | GU-06-0052/ethics 21781 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Alberta Health Services | ||||
| Study Sponsor ICMJE | Alberta Health Services | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Alberta Health Services | ||||
| Verification Date | April 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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