NSCLC/Oligometastatic Cancer (Single Lung Lesion)Phase 2SOURCE LungNCT04375904
'SOURCE - LUNG' Stereotactic Ablative Radiation Therapy Of UltRaCEntral LUNG Tumours (SOURCE Lung)
A Phase 2 study testing Image-Guided Stereotactic Ablative Radiotherapy (IG-SABR) in people with NSCLC/Oligometastatic Cancer (Single Lung Lesion), run by Cancer Trials Ireland at 2 sites in Ireland.
Trial summary
This is a phase II, non-randomised study examining the safety of treating high risk centrally located non-small cell lung cancer (NSCLC) tumours and single pulmonary oligometastatic lesions using radiation therapy (RT), for patients whose disease is inoperable. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSCLC/Oligometastatic Cancer (Single Lung Lesion)
- What is being tested?
- Image-Guided Stereotactic Ablative Radiotherapy (IG-SABR)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 2 sitesIreland
- Study dates
- 22 Dec 2020to Feb 2032
- 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
- Written informed consent obtained prior to any study-specific procedures
- ≥ 18 years of age
- Life expectancy >6 months
- ECOG (Eastern Cooperative Oncology Group) performance status 0-2
- Histological diagnosis (biopsy or cytology) or radiological diagnosis (PET-positive FDG-avid tumour which has only one lesion to be treated for the purpose of the study / CT-based diagnosis for non FDG-avid tumour) which requires local ablative therapy per Multi-Disciplinary Team (MDT) recommendations) of either:
- Primary NSCLC (Squamous Cell Carcinoma (SCC), Adenocarcinoma, Large Cell) OR (ii) Single pulmonary oligometastatic lesion to be treated for the purpose of the study
Show all 11Show fewer
- Patients with central lung tumours/lesions whose radiotherapy plan meets the following criteria:
- OAR eligibility constraints are initially exceeded when full PTV coverage is met; (ii) subsequently meets the CTRIAL-IE 18-33 SOURCE OAR Lung constraints and meets CTRIAL-IE 18-33 SOURCE Lung minimum constraints
- Inoperable (as per MDT) or patient refuses surgery,
- Females of childbearing potential must not be pregnant or lactating, must be prepared to take adequate contraception methods during treatment. Males whose female partners are of childbearing potential must be prepared to take adequate contraception methods during treatment. Examples of effective contraception methods are a condom or a diaphragm with spermicidal jelly, or oral, injectable or implanted birth control
- Absence of psychological, familial, sociological or geographical condition, or psychiatric illness/social situation potentially hampering compliance with the study protocol and follow-up schedule
Who cannot join
- Known co-existing or prior malignancy within the last 5 years (except for adequately treated basal cell carcinoma (BCC) or Squamous Cell Carcinoma (SCC) of the skin)) which is likely to interfere with treatment or assessment of outcomes
- Tumour/oligometastatic lesion that is abutting the oesophagus
- Evidence of regional (nodal) or distant metastases or metastatic pleural effusion for patients with primary NSCLC
- Spinal canal involvement
- Patients with syndromes or conditions associated with increased radiosensitivity
- Idiopathic pulmonary fibrosis / usual interstitial pneumonia
Show all 12Show fewer
- Chemotherapy and/or other targeted therapy administered within 3 months prior to study radiotherapy or planned for <6 weeks following radiotherapy for patients with primary NSCLC, or within 1 week prior to study radiotherapy or planned within 1 week following radiotherapy for patients with an oligometastatic lesion
- Any previous radiotherapy to the thorax or mediastinum (excluding previous breast or chest wall radiotherapy) which is likely to interfere with treatment or assessment of outcomes
- Any tumour not clinically definable on the treatment planning CT scan (e.g. surrounding consolidation or atelectasis)
- Patients unable to undergo 4D-CT scan
- Uncontrolled intercurrent illness that is likely to interfere with treatment or assessment of outcomes
- Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study, or if it is felt by the research / medical team that the patient may not be able to comply with the protocol.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Prof. John Armstrong contact
Ireland2 sites, 2 recruiting
- Recruiting
Beacon Hospital
Dublin
Prof Alina Mihai
Prof Alina Mihai
- Recruiting
St Luke's Radiation Oncology Network (SLRON) at St Luke's Hospital and St James's Hospital
Dublin
Prof. John Armstrong
John Armstrong
About this study
Official title: 'SOURCE - LUNG' Stereotactic Ablative Radiation Therapy Of UltRaCEntral LUNG Tumours
This is a phase II, non-randomised study examining the safety of treating high risk centrally located non-small cell lung cancer (NSCLC) tumours and single pulmonary oligometastatic lesions using radiation therapy (RT), for patients whose disease is inoperable. The method of delivering the RT in this study is image guided stereotactic ablative radiation therapy (IG-SABR). This method involves using imaging to ensure the radiation is being delivered to the correct location within the body and using higher than normal doses per treatment (fraction) to treat the lung cancer (NSCLC)/oligometastatic lung lesion. This study aims to determine its safety by looking at the number and severity of side effects. This study will deliver 8 treatments/fractions of RT with 7.5 Gy delivered in each fraction. To be eligible for this study the initial treatment plan for the patient must be shown to not fulfil certain criteria relating to doses to the tumour and surrounding normal tissue. This study has its own study specific criteria which must be adhered to. Translational sub-studies (optional) are open to patients in participating centres only. Patients will have the option to consent to participating in both translational studies or to neither.
Read the detailed description
This study is a phase II non-randomised, multi-centre, single arm trial of image-guided (IG)-SABR for patients with high-risk centrally located T1-T4 lung tumours (NSCLC) or a single pulmonary oligometastatic lesions. Treatment will consist of IG-SABR using a total of 8 fractions of 7.5 Gy per fraction adhering to organ at risk dose-volume histogram constraints allowing a minimum dose coverage of 75% to 95% of the planning target volume (PTV) coverage, and a minimum dose of 87% to 99% of the gross tumour volume (GTV), using dose intensity modulation.
The primary aim of the study is to determine the safety of the 8 x 7.5 Gy treatment regimen on the basis of the rate of ≥ Grade 3 treatment related toxicity using NCI CTCAE V5, in patients with medically inoperable early stage, ultracentrally located lung tumours. This is defined by central tumours which are not fulfilling the conservative hybrid DVCs of the LungTech (Adebahr et al., 2015), RTOG 0813 (Bezjak et al., 2015) studies and current UK consortium guidelines with full dose coverage, but which subsequently meet SOURCE DVC's with potentially reduced dose coverage. To remain in line with international practice, the SOURCE Lung protocol was amended to reduce near maximum dose constraints to 0.1cc for OARs (Diez et al. 2022). Toxicities occurring between start of treatment and one-year from the end of treatment, which are possibly, probably or definitely related to radiotherapy will be assessed.
A total of 60 evaluable patients will be required for the study. The sample size was calculated using continuous monitoring for toxicity, up to one year post RT, using a Pocock-type boundary. Accrual will be halted if excessive numbers of ≥ Grade 3 TxR-AEs are seen. The regime will not be considered to be safe if >25% of evaluable patients experience a ≥ Grade 3 treatment-related adverse event (TxR-AE) by the end of 1-year post-RT. This study will be considered adequately safe if ≤ 25% of evaluable patients experience ≥ Grade 3 TxR-AE by the end of 1 year post-RT.
The enrolment period is expected to be 6 years.
Toxicity assessments will be carried out weekly during radiotherapy (RT), at 2, 4 and 8-weeks post-treatment and at 3, 6, 9, 12, 18, 24 months post treatment and annually thereafter to 5 years post treatment.
Translational Sub-Study 1 (Raman spectroscopic analysis) - Primary aim is to undertake biomarker discovery using label-free Raman spectroscopy coupled with multivariate statistical methods to identify spectral biomarkers that could:
- Predict response based on individual radiation sensitivity
- Monitor response based on individual radiation sensitivity
Translational Sub-Study 2 (Proteomic analysis) - Primary aim is to use proteomic analysis of sequential blood samples before, during and after treatment to detect changes in protein expression profiles that may predict outcome and identify prognostic biochemical markers of early toxicity.
- Being tested
- Image-Guided Stereotactic Ablative Radiotherapy (IG-SABR)
- Keywords
- Lung cancer, Non-small cell lung cancer, Ultracentral, Stereotactic ablative radiation therapy, Oligometastatic cancer, Single lung lesion
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Image-Guided Stereotactic Ablative Radiotherapy (IG-SABR)Radiation
Image-Guided Stereotactic Ablative Radiotherapy (IG-SABR) delivered in 8 fractions of 7.5 Gy. OAR constraints must be respected but a minimum dose coverage to 95% of the PTV will be allowed down to 75% and a minimum dose to 99% of the GTV allowed at 75%. Respiratory monitoring/active respiratory management will be used. Plans will be created and delivered using photon beams with energies between 6-10 MV.
| Study group | Role | What they receive |
|---|---|---|
| Radiation | Experimental | Treatment will be delivered via image-guided (IG)-SABR in 8 fractions of 7.5Gy. OAR constraints must be respected but minimum dose coverage of 75% to 95% of the PTV will be allowed and minimum dose of 75% to 99% of the GTV will be allowed. The minimums are chosen to represent at least an equivalent BED to the RT standard fractionation of 55 Gy in 20 fractions based on actual treatment dose of 7.5Gy in 8 fractions. A total of 60 evaluable patients will be required for the study. The sample size was calculated using continuous monitoring for toxicity, up to one year post RT, using a Pocock-type boundary. Accrual will be halted if excessive numbers of ≥ Grade 3 TxR-AEs are seen. The regime will not be considered to be safe if >25% of evaluable patients experience a ≥ Grade 3 treatment-related adverse event (TxR-AE) by the end of 1-year post-RT. This study will be considered adequately safe if ≤ 25% of evaluable patients experience ≥ Grade 3 TxR-AE by the end of 1 year post-RT. Receives: Radiation: Image-Guided Stereotactic Ablative Radiotherapy (IG-SABR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of ≥ Grade 3 treatment-related toxicities occurring between start of treatment and one-year from the end of treatment using NCI CTCAE V5
The rates of ≥ Grade 3 treatment-related adverse events (TxR-AEs) will be calculated as the proportion of evaluable patients (along with the 95% CI) who have any >= Grade 3 treatment-related adverse event occurring between the start of RT and one year post-RT, among the total evaluable patients. These rates will be reported (for applicable patients) by T stage (T1 versus T2 versus T3 versus T4 or combined T stages). The NCI Common Terminology Criteria for Adverse Events (CTCAE Version 5.0) for scoring the treatment-related adverse events will be used.
The following will be reported at the time of primary endpoint analysis
- Tabulation of all cases entered, and any patients excluded from the analysis with reasons for exclusion;
- Distribution of important prognostic baseline and other pre-treatment variables;
- Frequency and severity of adverse events;
- Compliance rates of treatment delivery with respect to the protocol prescription
Measured: From start of treatment to 1 year post treatment
Secondary outcomes (2)
Estimate time to locoregional recurrence/progression, locoregional recurrence-free survival (LRFS), disease-free survival (DFS) and metastasis-free survival rates / further metastasis-free survival rates (for patients with an oligometastatic lesion).
The Kaplan-Meier method will be used to estimate time to locoregional recurrence; the cumulative proportion surviving without local recurrence at 1- year, 3-years and 5-years; DFS; metastasis-free survival for patients with primary NSCLC; further metastasis-free survival for patients with an oligometastatic lesion. These efficacy endpoints will be expressed as median survival with 95% confidence interval.
Measured: Up to 5 years post treatment
Estimates of 1-year, 3-year and 5-year overall survival rates
The Kaplan-Meier method will be used to estimate time the cumulative proportion surviving (overall survival) at 1-year, 3-years and 5-years.
Overall survival will be measured from date of registration/ enrolment. Patients alive and free of event at the time of analysis and patients lost to follow-up will be censored at the last available assessment. The event for overall survival is a death due to any cause. The primary time-point of interest is 12 months.
Measured: Up to 5 years post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2020
- Study start22 Dec 2020
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLC/Oligometastatic Cancer (Single Lung Lesion)Studies of the same condition, open and under way.
- 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
- Model description
- This is a phase II non-randomised, multi-centre, single arm trial assessing the safety of patients receiving image guided SABR in 8 fractions of 7.5Gy. The treatment will adhere to organ at risk dose-volume histogram constraints allowing a minimum dose coverage of 75% to 95% of the planning target volume (PTV) coverage, and a minimum dose of 75% to 99% of the gross tumour volume (GTV), using dose intensity modulation. These minimums are chosen to represent at least an equivalent BED to the RT standard fractionation of 55 Gy in 20 fractions based on actual treatment dose of 7.5 Gy in 8 fractions. The safety of the regimen will be based on the rate of ≥ Grade 3 treatment related toxicities per CTCAE V5 occurring between start of treatment and one-year from the end of treatment, which are possibly, probably or definitely related to radiotherapy.
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cancer Trials Ireland
- Sponsor type
- Research network
- Collaborators
- Technological University Dublin, University College Dublin
- Responsible party
- Sponsor
- Investigators
- Prof. John Armstrong, MD FRCPI DABR FFRRCSI, Principal investigator, Cancer Trials Ireland/ St Luke's Radiation Oncology Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04375904
- Sponsor's protocol ID
- CTRIAL-IE 18-33
- Acronym
- SOURCE Lung
- Status last verified
- Apr 2025
- First submitted
- 23 Apr 2020
- Last updated
- 2 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 'SOURCE - LUNG' Stereotactic Ablative Radiation Therapy Of UltRaCEntral LUNG Tumours
- ClinicalTrials.gov ID
- NCT04375904
- Acronym / sponsor ID
- SOURCE Lung / CTRIAL-IE 18-33
- Keywords
- Lung cancer, Non-small cell lung cancer, Ultracentral, Stereotactic ablative radiation therapy, Oligometastatic cancer, Single lung lesion
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Cancer Trials IrelandResearch network
- Collaborators
- Technological University Dublin, University College Dublin
- Study start
- 22 Dec 2020 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2032 (estimated)
- First posted
- 6 May 2020 (actual)
- 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.
This is a phase II, non-randomised study examining the safety of treating high risk centrally located non-small cell lung cancer (NSCLC) tumours and single pulmonary oligometastatic lesions using radiation therapy (RT), for patients whose disease is inoperable. The method of delivering the RT in this study is image guided stereotactic ablative radiation therapy (IG-SABR). This method involves using imaging to ensure the radiation is being delivered to the correct location within the body and using higher than normal doses per treatment (fraction) to treat the lung cancer (NSCLC)/oligometastatic lung lesion. This study aims to determine its safety by looking at the number and severity of side effects. This study will deliver 8 treatments/fractions of RT with 7.5 Gy delivered in each fraction. To be eligible for this study the initial treatment plan for the patient must be shown to not fulfil certain criteria relating to doses to the tumour and surrounding normal tissue. This study has its own study specific criteria which must be adhered to. Translational sub-studies (optional) are open to patients in participating centres only. Patients will have the option to consent to participating in both translational studies or to neither.
Detailed description
This study is a phase II non-randomised, multi-centre, single arm trial of image-guided (IG)-SABR for patients with high-risk centrally located T1-T4 lung tumours (NSCLC) or a single pulmonary oligometastatic lesions. Treatment will consist of IG-SABR using a total of 8 fractions of 7.5 Gy per fraction adhering to organ at risk dose-volume histogram constraints allowing a minimum dose coverage of 75% to 95% of the planning target volume (PTV) coverage, and a minimum dose of 87% to 99% of the gross tumour volume (GTV), using dose intensity modulation.
The primary aim of the study is to determine the safety of the 8 x 7.5 Gy treatment regimen on the basis of the rate of ≥ Grade 3 treatment related toxicity using NCI CTCAE V5, in patients with medically inoperable early stage, ultracentrally located lung tumours. This is defined by central tumours which are not fulfilling the conservative hybrid DVCs of the LungTech (Adebahr et al., 2015), RTOG 0813 (Bezjak et al., 2015) studies and current UK consortium guidelines with full dose coverage, but which subsequently meet SOURCE DVC's with potentially reduced dose coverage. To remain in line with international practice, the SOURCE Lung protocol was amended to reduce near maximum dose constraints to 0.1cc for OARs (Diez et al. 2022). Toxicities occurring between start of treatment and one-year from the end of treatment, which are possibly, probably or definitely related to radiotherapy will be assessed.
A total of 60 evaluable patients will be required for the study. The sample size was calculated using continuous monitoring for toxicity, up to one year post RT, using a Pocock-type boundary. Accrual will be halted if excessive numbers of ≥ Grade 3 TxR-AEs are seen. The regime will not be considered to be safe if >25% of evaluable patients experience a ≥ Grade 3 treatment-related adverse event (TxR-AE) by the end of 1-year post-RT. This study will be considered adequately safe if ≤ 25% of evaluable patients experience ≥ Grade 3 TxR-AE by the end of 1 year post-RT.
The enrolment period is expected to be 6 years.
Toxicity assessments will be carried out weekly during radiotherapy (RT), at 2, 4 and 8-weeks post-treatment and at 3, 6, 9, 12, 18, 24 months post treatment and annually thereafter to 5 years post treatment.
Translational Sub-Study 1 (Raman spectroscopic analysis) - Primary aim is to undertake biomarker discovery using label-free Raman spectroscopy coupled with multivariate statistical methods to identify spectral biomarkers that could:
- Predict response based on individual radiation sensitivity
- Monitor response based on individual radiation sensitivity
Translational Sub-Study 2 (Proteomic analysis) - Primary aim is to use proteomic analysis of sequential blood samples before, during and after treatment to detect changes in protein expression profiles that may predict outcome and identify prognostic biochemical markers of early toxicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a phase II non-randomised, multi-centre, single arm trial assessing the safety of patients receiving image guided SABR in 8 fractions of 7.5Gy. The treatment will adhere to organ at risk dose-volume histogram constraints allowing a minimum dose coverage of 75% to 95% of the planning target volume (PTV) coverage, and a minimum dose of 75% to 99% of the gross tumour volume (GTV), using dose intensity modulation. These minimums are chosen to represent at least an equivalent BED to the RT standard fractionation of 55 Gy in 20 fractions based on actual treatment dose of 7.5 Gy in 8 fractions. The safety of the regimen will be based on the rate of ≥ Grade 3 treatment related toxicities per CTCAE V5 occurring between start of treatment and one-year from the end of treatment, which are possibly, probably or definitely related to radiotherapy.
| Arm | Type | Receives |
|---|---|---|
| Radiation | Experimental | Radiation: Image-Guided Stereotactic Ablative Radiotherapy (IG-SABR)Treatment will be delivered via image-guided (IG)-SABR in 8 fractions of 7.5Gy. OAR constraints must be respected but minimum dose coverage of 75% to 95% of the PTV will be allowed and minimum dose of 75% to 99% of the GTV will be allowed. The minimums are chosen to represent at least an equivalent BED to the RT standard fractionation of 55 Gy in 20 fractions based on actual treatment dose of 7.5Gy in 8 fractions. A total of 60 evaluable patients will be required for the study. The sample size was calculated using continuous monitoring for toxicity, up to one year post RT, using a Pocock-type boundary. Accrual will be halted if excessive numbers of ≥ Grade 3 TxR-AEs are seen. The regime will not be considered to be safe if >25% of evaluable patients experience a ≥ Grade 3 treatment-related adverse event (TxR-AE) by the end of 1-year post-RT. This study will be considered adequately safe if ≤ 25% of evaluable patients experience ≥ Grade 3 TxR-AE by the end of 1 year post-RT. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Written informed consent obtained prior to any study-specific procedures
- ≥ 18 years of age
- Life expectancy >6 months
- ECOG (Eastern Cooperative Oncology Group) performance status 0-2
- Histological diagnosis (biopsy or cytology) or radiological diagnosis (PET-positive FDG-avid tumour which has only one lesion to be treated for the purpose of the study / CT-based diagnosis for non FDG-avid tumour) which requires local ablative therapy per Multi-Disciplinary Team (MDT) recommendations) of either:
Key exclusion criteria (12 listed)
- Known co-existing or prior malignancy within the last 5 years (except for adequately treated basal cell carcinoma (BCC) or Squamous Cell Carcinoma (SCC) of the skin)) which is likely to interfere with treatment or assessment of outcomes
- Tumour/oligometastatic lesion that is abutting the oesophagus
- Evidence of regional (nodal) or distant metastases or metastatic pleural effusion for patients with primary NSCLC
- Spinal canal involvement
- Patients with syndromes or conditions associated with increased radiosensitivity
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 |
|---|---|---|
| Image-Guided Stereotactic Ablative Radiotherapy (IG-SABR)Image-Guided Stereotactic Ablative Radiotherapy (IG-SABR) delivered in 8 fractions of 7.5 Gy. OAR constraints must be respected but a minimum dose coverage to 95% of the PTV will be allowed down to 75% and a minimum dose to 99% of the GTV allowed at 75%. Respiratory monitoring/active respiratory management will be used. Plans will be created and delivered using photon beams with energies between 6-10 MV. | Radiation | Radiation |
Primary outcome
The rate of ≥ Grade 3 treatment-related toxicities occurring between start of treatment and one-year from the end of treatment using NCI CTCAE V5
Time frame: From start of treatment to 1 year post treatment
The rates of ≥ Grade 3 treatment-related adverse events (TxR-AEs) will be calculated as the proportion of evaluable patients (along with the 95% CI) who have any >= Grade 3 treatment-related adverse event occurring between the start of RT and one year post-RT, among the total evaluable patients. These rates will be reported (for applicable patients) by T stage (T1 versus T2 versus T3 versus T4 or combined T stages). The NCI Common Terminology Criteria for Adverse Events (CTCAE Version 5.0) for scoring the treatment-related adverse events will be used. The following will be reported at the time of primary endpoint analysis * Tabulation of all cases entered, and any patients excluded from the analysis with reasons for exclusion; * Distribution of important prognostic baseline and other pre-treatment variables; * Frequency and severity of adverse events; * Compliance rates of treatment delivery with respect to the protocol prescription
2 secondary outcomes
Estimate time to locoregional recurrence/progression, locoregional recurrence-free survival (LRFS), disease-free survival (DFS) and metastasis-free survival rates / further metastasis-free survival rates (for patients with an oligometastatic lesion).
Time frame: Up to 5 years post treatment
Estimates of 1-year, 3-year and 5-year overall survival rates
Time frame: Up to 5 years post treatment
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 2 May 2025.
- Individual participant dataSharing planned: Undecided
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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.
Prof. John Armstrong contact
Prof. John Armstrong, MD FRCPI DABR FFRRCSI principal investigator
Cancer Trials Ireland/ St Luke's Radiation Oncology Network
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Image-Guided Stereotactic Ablative Radiotherapy (IG-SABR) in people with NSCLC/Oligometastatic Cancer (Single Lung Lesion), run by Cancer Trials Ireland at 2 sites in Ireland.
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 11 inclusion and 12 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 2 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Ireland. 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 Cancer Trials Ireland (+353 1 6677211, info@cancertrials.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of ≥ Grade 3 treatment-related toxicities occurring between start of treatment and one-year from the end of treatment using NCI CTCAE V5 (time frame: From start of treatment to 1 year post treatment). 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 2 May 2025.