Stereotactic Radiotherapy (SBRT) of Lung Metastasis
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ClinicalTrials.gov Identifier: NCT01803542 |
Recruitment Status :
Recruiting
First Posted : March 4, 2013
Last Update Posted : October 24, 2022
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Tracking Information | |||||
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First Submitted Date ICMJE | August 10, 2010 | ||||
First Posted Date ICMJE | March 4, 2013 | ||||
Last Update Posted Date | October 24, 2022 | ||||
Actual Study Start Date ICMJE | March 2006 | ||||
Estimated Primary Completion Date | February 2023 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Stereotactic Radiotherapy (SBRT) of Lung Metastasis | ||||
Official Title ICMJE | Lung Stereotactic Radiation Therapy for Patients With Non-small Cell Lung Cancer and Other Cancers | ||||
Brief Summary | The purpose of this institutional protocol is to offer SBRT to selected patients in a controlled environment to refine treatment techniques (including dose/fractionation schedules) and standardize follow-up. SBRT has been in clinical use for over a decade in some institutions and the available data suggest that it can be used safely and with good results. This study will see how effective Stereotactic Body Radiation Therapy is for treating tumours in the lung and how often people have side effects. Radiation therapy is usually given once a day, often for a few weeks. In this study, study participants will receive high doses of radiation treatment to tumours in the lung for 3 to 10 treatment sessions over a total of about 1 to 2 weeks. Several reports indicate that this therapy might shrink tumours and control the cancer for extended periods of time. Although specialists started to treat patients with SBRT over 10 years ago, it is still used in relatively few cancer centres. |
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Detailed Description | SBRT is an adaptation of the principles and experience gained from stereotactic brain RT. SBRT was developed in the early 90s at the Karolinska Institute in Stockholm, Sweden, and is used as an accepted alternative of treatment for patients with early stage lung cancer in many centers in Japan and a number of centers in Germany,USA and elsewhere. It is also now being used for patients who have lung metastases and extra-thoracic disease (primary or metastatic). Many reports indicate excellent local control (80-90% or higher) and minimal toxicity in well selected patients treated with thoracic SBRT. SBRT has traditionally had the following features:
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 2 | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | Radiation: Stereotactic Radiation
Participants will receive high doses of radiation treatment to tumours in the lung for 3 to 10 treatment sessions over a total of about 1 to 2 weeks.
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Study Arms ICMJE | Experimental: SBRT
High dose of radiation will be used to treat tumours.
Intervention: Radiation: Stereotactic Radiation
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Publications * | Not Provided | ||||
* 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 | Recruiting | ||||
Estimated Enrollment ICMJE |
200 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | February 2023 | ||||
Estimated Primary Completion Date | February 2023 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Canada | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT01803542 | ||||
Other Study ID Numbers ICMJE | UHN REB 05-0951-C | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product | Not Provided | ||||
IPD Sharing Statement ICMJE | Not Provided | ||||
Current Responsible Party | University Health Network, Toronto | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | University Health Network, Toronto | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Princess Margaret Hospital, Canada | ||||
Investigators ICMJE |
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PRS Account | University Health Network, Toronto | ||||
Verification Date | October 2022 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |