Non-small Cell Lung CancerPhase 2SBRT LungNCT01803542
Stereotactic Radiotherapy (SBRT) of Lung Metastasis
A Phase 2 study testing Stereotactic Radiation in people with Non-small Cell Lung Cancer and Metastasis From Other Cancers, run by University Health Network, Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer, Metastasis From Other Cancers
- What is being tested?
- Stereotactic Radiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2006to Sep 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histological confirmation of malignancy, unless the risks of biopsy are unacceptable and the lesion has grown on serial CT scan and/or is PET positive.
- Eligible patients must have staging studies (e.g. chest radiograph, CT scan, MRI/CT Brain/Bone Scan) identifying them as:
- patients with stage I or II, non-metastatic NSCLC (T1, N0, M0; T2, N0, M0; or T3, N0, M0 chest wall primary tumors only)
- patients with a non-lung primary that is controlled and which has metastasized to the lungs alone, in whom potentially curative surgery would otherwise be an option (e.g. colorectal, breast, sarcoma…etc)
- the subset of patients with limited (low) volume metastatic NSCLC or other primary site tumors whom it is felt may derive benefit from highdose SBRT treatment to the primary or metastatic lung tumor. And in whom other sites of metastatic disease are being treated with the desire to achieve long term control. Lesions must meet size criteria in 4.1.2.1
- Patients who have potentially resectable disease should be considered medically inoperable, or else in the judgement of the thoracic surgeon and lung team, surgery is not considered the preferred management option
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- Early stage lung cancer: ≤3 parenchymal lung lesions, Metastatic disease to lungs: ≤5 parenchymal lung lesions
- Patients with early stage primary NSCLC should have hilar or mediastinal lymph nodes that are considered N0 on clinico-radiological grounds (i.e. no clinico-radiological evidence of lymph node spread)
- In patients with early stage primary NSCLC and a co-existing malignancy, the co-existing malignancy must have an expected prognosis better than primary lung lesion
- Adequate lung function to tolerate the planned stereotactic radiation
- Previous conventional RT to mediastinum/lung allowed as long as SBRT is not expected to have a high probability of impairing lung function
- Must be ≥ 18 years of age
- Zubrod performance status must be between 0 and 3
- Women of child bearing potential and male participants must use an effective contraceptive method
- Willing and able to give informed consent
Who cannot join
- Patients with active systemic, pulmonary or pericardial infection
- No concurrent systemic therapy (chemotherapy, immunotherapy or biological therapy), apart from hormone therapy, is allowed
- History of active auto-immune diseases, including systemic lupus erythematous, rheumatoid arthritis, C.R.E.S.T., systemic sclerosis,scleroderma
- Potential candidate for concurrent chemo-radiation therapy
- Patient enrollment on other studies may be permissible. This will depend on patient and study characteristics.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Princess Margaret Hospital, University Health Network
Toronto, Ontario, M5G 2M9
John Cho, MD, 416 946 2124, John.Cho@rmp.uhn.on.ca
John Cho, MD
About this study
Official title: Lung Stereotactic Radiation Therapy for Patients With Non-small Cell Lung Cancer and Other Cancers
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.
Read the 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:
- 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)
- Being tested
- Stereotactic Radiation
- Keywords
- Non-small Cell Lung Cancer, Stereotactic radiation for Lung Cancer, Cone beam CT for Lung Cancer, PET/CT for Lung Cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic RadiationRadiation
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.
| Study group | Role | What they receive |
|---|---|---|
| SBRT | Experimental | High dose of radiation will be used to treat tumours. Receives: Radiation: Stereotactic Radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine local control in patients treated with SBRT.
Measured: 10 years
Determine pattern of relapse in patients treated with SBRT.
Measured: 10
Determine survival rates in patients treated with SBRT.
Measured: 10
Secondary outcomes (8)
To characterize acute and late toxicity
Measured: 10 years
Assess the use of PET/CT in aiding target definition and predicting local response
Measured: 10 years
Assess the use of Cone Beam CT for precision imaging of the target and avoidance structures at each treatment
Measured: 10 years
Assess the use of 4D-computed tomography (CT) planning to determine Internal Treatment Volume (ITV) and Planning Treatment Volume (PTV)
Measured: 10 years
Develop organ motion prediction models
Measured: 10 years
Monitor major adverse cardiac events
Measured: 10 years
Monitor all-cause mortality
Measured: 10 years
Monitor cancer specific mortality
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2013 (estimated)
- Study startMar 2006
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Princess Margaret Hospital, Canada
- Responsible party
- Sponsor
- Investigators
- John Cho, MD, Principal investigator, University Health Network, Princess Margaret Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01803542
- Sponsor's protocol ID
- 05-0951
- Acronym
- SBRT Lung
- Status last verified
- Mar 2026
- First submitted
- 10 Aug 2010
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung Stereotactic Radiation Therapy for Patients With Non-small Cell Lung Cancer and Other Cancers
- ClinicalTrials.gov ID
- NCT01803542
- Acronym / sponsor ID
- SBRT Lung / 05-0951
- Keywords
- Non-small Cell Lung Cancer, Stereotactic radiation for Lung Cancer, Cone beam CT for Lung Cancer, PET/CT for Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Princess Margaret Hospital, Canada
- Study start
- Mar 2006 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 4 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SBRT | Experimental | Radiation: Stereotactic RadiationHigh dose of radiation will be used to treat tumours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Histological confirmation of malignancy, unless the risks of biopsy are unacceptable and the lesion has grown on serial CT scan and/or is PET positive.
- Eligible patients must have staging studies (e.g. chest radiograph, CT scan, MRI/CT Brain/Bone Scan) identifying them as:
- patients with stage I or II, non-metastatic NSCLC (T1, N0, M0; T2, N0, M0; or T3, N0, M0 chest wall primary tumors only)
- patients with a non-lung primary that is controlled and which has metastasized to the lungs alone, in whom potentially curative surgery would otherwise be an option (e.g. colorectal, breast, sarcoma…etc)
- the subset of patients with limited (low) volume metastatic NSCLC or other primary site tumors whom it is felt may derive benefit from highdose SBRT treatment to the primary or metastatic lung tumor. And in whom other sites of metastatic disease are being treated with the desire to achieve long term control. Lesions must meet size criteria in 4.1.2.1
Key exclusion criteria (5 listed)
- Patients with active systemic, pulmonary or pericardial infection
- No concurrent systemic therapy (chemotherapy, immunotherapy or biological therapy), apart from hormone therapy, is allowed
- History of active auto-immune diseases, including systemic lupus erythematous, rheumatoid arthritis, C.R.E.S.T., systemic sclerosis,scleroderma
- Potential candidate for concurrent chemo-radiation therapy
- Patient enrollment on other studies may be permissible. This will depend on patient and study characteristics.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stereotactic RadiationParticipants 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. | Radiation | SBRT |
Primary outcome
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
8 secondary outcomes
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
Develop organ motion prediction models
Time frame: 10 years
Monitor major adverse cardiac events
Time frame: 10 years
Monitor all-cause mortality
Time frame: 10 years
Monitor cancer specific mortality
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
John Cho, MD principal investigator
University Health Network, Princess Margaret Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Stereotactic Radiation in people with Non-small Cell Lung Cancer and Metastasis From Other Cancers, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact John Cho, MD (416 946 2124, John.Cho@rmp.uhn.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine local control in patients treated with SBRT. (time frame: 10 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.