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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | November 24, 2008 | ||||
| Last Updated Date | October 14, 2009 | ||||
| Start Date ICMJE | December 2008 | ||||
| Estimated Primary Completion Date | October 2016 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Incidence of grade 2-4 gastrointestinal and genitourinary toxicity [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00798837 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Intraprostatic MAXimal Simultaneous Boost | ||||
| Official Title ICMJE | A Dose-escalation Study Using a Maximal Simultaneous Intraprostatic Boost With RapidArc Intensity Modulated Radiotherapy in Intermediate Risk Prostate Cancer | ||||
| Brief Summary | This trial uses a type of radiotherapy called intensity modulated radiotherapy (IMRT), which is able to deliver the radiation to the prostate while delivering less dose to the surrounding normal organs compared with standard 3D conformal radiotherapy presently used at the BCCA. This trial will use RapidArc IMRT, which is a new way of delivering IMRT, where the radiation dose is delivered in a single rotation of the radiotherapy machine around the patient. This new method of delivering IMRT has been shown to be at least as good as conventional IMRT at delivering the dose, and takes less time to do so. The aim of this study is to deliver a higher radiation dose to the prostate gland than the standard treatment while not increasing dose to the normal organs. In this way, it is hoped that the likelihood of the cancer coming back will be reduced without causing an increase in side-effects. |
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| Detailed Description | |||||
| Study Phase | Phase I | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE | Prostate Cancer | ||||
| Intervention ICMJE | Radiation: Intraprostatic maximal simultaneous boost | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 30 | ||||
| Estimated Completion Date | October 2016 | ||||
| Estimated Primary Completion Date | October 2016 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria: 1. Subjects that do not meet inclusion criteria. |
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| Gender | Male | ||||
| Ages | |||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | |||||
| Location Countries ICMJE | Canada | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00798837 | ||||
| Responsible Party | William James Morris/Radiation Oncologist, British Columbia Cancer Agency | ||||
| Study ID Numbers ICMJE | IMAX | ||||
| Study Sponsor ICMJE | British Columbia Cancer Agency | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | British Columbia Cancer Agency | ||||
| Verification Date | October 2009 | ||||
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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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