Short-course Hypofractionated Radiotherapy for Localized Prostate Cancer
This study has been completed.
Sponsor:
Alberta Health Services
Collaborator:
Calgary Health Region
Information provided by:
Alberta Health Services
ClinicalTrials.gov Identifier:
NCT00126165
First received: August 2, 2005
Last updated: January 18, 2012
Last verified: January 2012
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | August 2, 2005 | ||||
| Last Updated Date | January 18, 2012 | ||||
| Start Date ICMJE | September 2004 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
rectal morbidity | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00126165 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Short-course Hypofractionated Radiotherapy for Localized Prostate Cancer | ||||
| Official Title ICMJE | A Phase I/II Study of Escalated-dose Short-course Hypofractionated Radiotherapy (55 Gy/16 Fractions/4 Weeks) for Localized Prostate Cancer | ||||
| Brief Summary | This study is aimed at providing further clinical evidence to support or refute the current understanding of biological sensitivity of prostate cancer to fractionated radiotherapy. Determining the morbidity and cancer control provided by a 4-week course of treatment will greatly influence future radiotherapy services for patients with localized prostate cancer. |
||||
| Detailed Description | This study is aimed at providing further clinical evidence to support or refute the current understanding of biological sensitivity of prostate cancer to fractionated radiotherapy. Determining the morbidity and cancer control provided by a 4-week course of treatment will greatly influence future radiotherapy services for patients with localized prostate cancer. |
||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 1 Phase 2 |
||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
||||
| Condition ICMJE | Prostate Cancer | ||||
| Intervention ICMJE | Procedure: radiotherapy | ||||
| Study Arm (s) | Not Provided | ||||
| Publications * | Wu JS, Brasher PM, El-Gayed A, Pervez N, Tai PT, Robinson J, Skarsgard D, Joseph K, Sia MA, Pearcey RG. Phase II study of hypofractionated image-guided radiotherapy for localized prostate cancer: outcomes of 55 Gy in 16 fractions at 3.4 Gy per fraction. Radiother Oncol. 2012 May;103(2):210-6. Epub 2012 Jan 24. | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 72 | ||||
| Completion Date | August 2011 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Male | ||||
| Ages | 18 Years and older | ||||
| 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 | NCT00126165 | ||||
| Other Study ID Numbers ICMJE | 17885, 17885 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | Alberta Health Services | ||||
| Collaborators ICMJE | Calgary Health Region | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | Alberta Health Services | ||||
| Verification Date | January 2012 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||