Stereotactic Radiotherapy (SBRT) of Lung Metastasis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01803542|
Recruitment Status : Recruiting
First Posted : March 4, 2013
Last Update Posted : April 13, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|Non-small Cell Lung Cancer Metastasis From Other Cancers||Radiation: Stereotactic Radiation||Phase 2|
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:
- High doses of radiation, usually in a few large fractions (it is "hypofractionated" compared with standard radiotherapy schedules)
- Multiple radiation beams coming from different directions in the same plane ('co-planar' beams) as well as from different directions and different planes relative to the patient's body ('non-coplanar' beams)
- Stereotactic beam placement, in that it is guided by a set of coordinates These coordinates are defined in relationship to the precise location of the tumor, determined from medical imaging (e.g. CT, MRI), rather than to a set of external marks (tattoos) or anatomical landmarks (such as bony structures)
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Lung Stereotactic Radiation Therapy for Patients With Non-small Cell Lung Cancer and Other Cancers|
|Actual Study Start Date :||March 2006|
|Estimated Primary Completion Date :||March 2022|
|Estimated Study Completion Date :||March 2022|
High dose of radiation will be used to treat tumours.
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.
- Determine local control in patients treated with SBRT. [ Time Frame: 10 years ]
- Determine pattern of relapse in patients treated with SBRT. [ Time Frame: 10 ]
- Determine survival rates in patients treated with SBRT. [ Time Frame: 10 ]
- To characterize acute and late toxicity [ Time Frame: 10 years ]
- Assess the use of PET/CT in aiding target definition and predicting local response [ Time Frame: 10 years ]
- Assess the use of Cone Beam CT for precision imaging of the target and avoidance structures at each treatment [ Time Frame: 10 years ]
- Assess the use of 4D-computed tomography (CT) planning to determine Internal Treatment Volume (ITV) and Planning Treatment Volume (PTV) [ Time Frame: 10 years ]
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): NCT01803542
|Contact: John Cho, MD||416 946 2124||John.Cho@rmp.uhn.on.ca|
|Princess Margaret Hospital, University Health Network||Recruiting|
|Toronto, Ontario, Canada, M5G 2M9|
|Contact: John Cho, MD 416 946 2124 John.Cho@rmp.uhn.on.ca|
|Principal Investigator: John Cho, MD|
|Principal Investigator:||John Cho, MD||University Health Network, Princess Margaret Hospital|