Non-small Cell Lung CancerPhase 3LUSTRENCT01968941
Stereotactic Body Radiotherapy Versus Conventional Radiotherapy in Medically-Inoperable Non-Small Lung Cancer Patients
A Phase 3 study testing Stereotactic Body Radiotherapy (SBRT) and Conventional Radiotherapy (CRT) in people with Non-small Cell Lung Cancer, run by Ontario Clinical Oncology Group (OCOG) at 16 sites in Canada.
Trial summary
A multi-centre randomized controlled open-label trial in medically inoperable patients with biopsy-proven early stage non-small cell lung cancer (NSCLC). Eligible and consenting patients will be randomly allocated to receive stereotactic body radiotherapy (SBRT) or conventional radiotherapy (CRT) in a 2:1 ratio. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- Stereotactic Body Radiotherapy (SBRT) and Conventional Radiotherapy (CRT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 324 participants
- Where
- 16 sitesCanada
- Study dates
- 7 May 2014to May 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- T1/T2a N0 M0 NSCLC, either by: (a) histological confirmation (squamous cell, adenocarcinoma, large cell carcinoma, or not specified) and CT thorax and/or PET-CT evidence, or (b) a suspicious growing nodule on serial CT imaging, with malignant PET Fluorodeoxyglucose (FDG) avidity, for which a biopsy would be extremely risky.
- Deemed medically inoperable (as reviewed by a thoracic surgeon and defined as surgically resectable but, because of underlying physiological medical problems [e.g. chronic obstructive pulmonary disease (COPD), heart disease], surgery is contraindicated) or Radiotherapy is preferred by the patient due to high operable risk.
Who cannot join
- Less than 18 years of age.
- Eastern Cooperative Oncology Group (ECOG) performance status 3 or higher.
- Prior invasive malignancy within the past 3 years (excluding non-melanomatous skin cancer).
- History of ataxia telangiectasia.
- Previous radiotherapy (RT) in the vicinity of the tumour, such that significant overlap could occur.
- Previous pneumonectomy with Stage I lung cancer in the remaining lung.
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- Diagnosis of idiopathic pulmonary fibrosis and/or interstitial lung disease.
- Planned for other anticancer therapy (chemotherapy, biological targeted therapy).
- Female, who is currently pregnant or lactating.
- Geographic inaccessibility for follow-up.
- Unable to provide informed consent.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
Canada16 sites
Tom Baker Cancer Centre
Calgary, Alberta
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
Charles LeMoyne Hospital
Greenfield Park, Quebec, J4V 2H1
Juravinski Hospital and Cancer Centre
Hamilton, Ontario
Cancer Centre of Southeastern Ontario at the Kingston General Hospital
Kingston, Ontario, K7L 2V7
London Regional Cancer Program at London Health Sciences Centre
London, Ontario
CHUM Hospital Notre Dame
Montreal, Quebec
Hôpital Maisonneuve-Rosemont
Montreal, Quebec
Montreal General Hospital McGill
Montreal, Quebec
Allan Blair Cancer Centre
Regina, Saskatchewan, S4T 7T1
Horizon Health Network
Saint John, New Brunswick
Saskatoon Cancer Centre
Saskatoon, Saskatchewan
Niagara Health System-Walker Family Cancer Centre
St. Catharines, Ontario
Thunder Bay Regional Health Sciences Centre
Thunder Bay, Ontario
Windsor Regional Cancer Centre
Windsor, Ontario
Cancer Care Manitoba
Winnipeg, Manitoba
About this study
Official title: A Randomized Trial of Medically-Inoperable Stage 1 Non-small Cell Lung Cancer Patients Comparing Stereotactic Body Radiotherapy Versus Conventional Radiotherapy
A multi-centre randomized controlled open-label trial in medically inoperable patients with biopsy-proven early stage non-small cell lung cancer (NSCLC). Eligible and consenting patients will be randomly allocated to receive stereotactic body radiotherapy (SBRT) or conventional radiotherapy (CRT) in a 2:1 ratio. Radiotherapy will be administered as soon as possible following randomization and subjects will be followed for 5 years post-randomization for cancer recurrence, toxicity and survival. The primary outcome is local control (LC). The trial will be conducted at 16-20 clinical centres throughout Canada.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Stereotactic Body Radiotherapy (SBRT), Conventional Radiotherapy (CRT)
- Keywords
- stereotactic body radiotherapy, conventional radiotherapy, inoperable patients, local control, cancer recurrence, toxicity, survival
- 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 Body Radiotherapy (SBRT)Radiation
Conventional Radiotherapy (CRT)Radiation
| Study group | Role | What they receive |
|---|---|---|
| Stereotactic Body Radiotherapy | Experimental | Stereotactic Body Radiotherapy (SBRT) Receives: Radiation: Stereotactic Body Radiotherapy (SBRT) |
| Conventional Radiotherapy | Active comparator | Conventional Radiotherapy (CRT) Receives: Radiation: Conventional Radiotherapy (CRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local Control
Local control is the absence of local recurrence during the study period. This is the time from randomization to primary tumour failure or marginal failure.
Measured: 5 years
Secondary outcomes (8)
Overall Survival
Overall Survival is defined as the time from randomization to death from any cause. Alive subjects will be censored on the date of last follow-up.
Measured: 5 years
Disease-Free Survival
Disease-Free Survival is defined as the time from randomization to the earliest recurrence of disease or to death attributed to lung cancer.
Measured: 5 years
Event-Free Survival
Event-Free Survival is defined as the time from randomization to the earliest documented recurrent disease or death from any cause.
Measured: 5 years
Lung Cancer-Specific Survival
Lung Cancer-Specific Survival is defined as the time from randomization to death attributable to lung cancer
Measured: 5 years
Radiation Treatment-Related Death
Radiation Treatment-Related Death is defined as death occurring between 1 to 12 months following treatment, and caused directly by radiation toxicity attributed to either catastrophic hemorrhage or to severe radiation pneumonitis leading to death
Measured: 1 to 12 months
Toxicity
Acute Toxicity will be assessed at 3 months post-randomization and includes fatigue, dyspnea and esophagitis. Late toxicity will be assessed beyond 3 months and up to 5 years and includes radiation pneumonitis, chest wall pain and rib fracture.
Measured: 5 years
Quality of Life
Impact on quality of life will be assessed with the European Organization for Research in Treatment of Cancer and the Lung Cancer-specific Module 13 questionnaires.
Measured: 2 years
Cost-Utility
Cost-Utility will be assessed using the European Quality of Life questionnaire in conjunction with the overall survival results
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2013 (estimated)
- Study start7 May 2014
- Primary completion28 Feb 2022
- Study completionMay 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Non-small Cell Lung CancerStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 324 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ontario Clinical Oncology Group (OCOG)
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Cancer Society (CCS)
- Responsible party
- Sponsor
- Investigators
- Anand Swaminath, Principal investigator, Ontario Clinical Oncology Group (OCOG)Tim Whelan, Principal investigator, Ontario Clinical Oncology Group (OCOG)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01968941
- Sponsor's protocol ID
- OCOG-2013-LUSTRE
- Acronym
- LUSTRE
- Status last verified
- Sep 2022
- First submitted
- 21 Oct 2013
- Last updated
- 21 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wang Y, Donovan EK, Levine MN, Whelan TJ, Swaminath A, Parpia S; LUSTRE Trial Investigators. Stereotactic Versus Conventional Radiotherapy in Medically Inoperable Stage I Non-Small Cell Lung Cancer: A Bayesian Reanalysis of the LUSTRE Randomized Trial. Clin Lung Cancer. 2026 May;27(4):117-122.e4. doi: 10.1016/j.cllc.2026.03.008. Epub 2026 Mar 26.
PubMed 41997828Rosenberg SA, Mak R, Kotecha R, Loo BW Jr, Senan S. The Nordic-HILUS Trial: Ultracentral Lung Stereotactic Ablative Radiotherapy and a Narrow Therapeutic Window. J Thorac Oncol. 2021 Oct;16(10):e79-e80. doi: 10.1016/j.jtho.2021.06.030. No abstract available.
PubMed 34561039
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Medically-Inoperable Stage 1 Non-small Cell Lung Cancer Patients Comparing Stereotactic Body Radiotherapy Versus Conventional Radiotherapy
- ClinicalTrials.gov ID
- NCT01968941
- Acronym / sponsor ID
- LUSTRE / OCOG-2013-LUSTRE
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- stereotactic body radiotherapy, conventional radiotherapy, inoperable patients, local control, cancer recurrence, toxicity, survival
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 324 participants (estimated)
- Lead sponsor
- Ontario Clinical Oncology Group (OCOG)University, hospital or other
- Collaborators
- Canadian Cancer Society (CCS)
- Study start
- 7 May 2014 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- May 2022 (actual)
- First posted
- 24 Oct 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.
A multi-centre randomized controlled open-label trial in medically inoperable patients with biopsy-proven early stage non-small cell lung cancer (NSCLC). Eligible and consenting patients will be randomly allocated to receive stereotactic body radiotherapy (SBRT) or conventional radiotherapy (CRT) in a 2:1 ratio. Radiotherapy will be administered as soon as possible following randomization and subjects will be followed for 5 years post-randomization for cancer recurrence, toxicity and survival. The primary outcome is local control (LC). The trial will be conducted at 16-20 clinical centres throughout Canada.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stereotactic Body Radiotherapy | Experimental | Radiation: Stereotactic Body Radiotherapy (SBRT)Stereotactic Body Radiotherapy (SBRT) |
| Conventional Radiotherapy | Active comparator | Radiation: Conventional Radiotherapy (CRT)Conventional Radiotherapy (CRT) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- T1/T2a N0 M0 NSCLC, either by: (a) histological confirmation (squamous cell, adenocarcinoma, large cell carcinoma, or not specified) and CT thorax and/or PET-CT evidence, or (b) a suspicious growing nodule on serial CT imaging, with malignant PET Fluorodeoxyglucose (FDG) avidity, for which a biopsy would be extremely risky.
- Deemed medically inoperable (as reviewed by a thoracic surgeon and defined as surgically resectable but, because of underlying physiological medical problems [e.g. chronic obstructive pulmonary disease (COPD), heart disease], surgery is contraindicated) or Radiotherapy is preferred by the patient due to high operable risk.
Key exclusion criteria (11 listed)
- Less than 18 years of age.
- Eastern Cooperative Oncology Group (ECOG) performance status 3 or higher.
- Prior invasive malignancy within the past 3 years (excluding non-melanomatous skin cancer).
- History of ataxia telangiectasia.
- Previous radiotherapy (RT) in the vicinity of the tumour, such that significant overlap could occur.
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 Body Radiotherapy (SBRT) | Radiation | Stereotactic Body Radiotherapy |
| Conventional Radiotherapy (CRT) | Radiation | Conventional Radiotherapy |
Primary outcome
Local Control
Time frame: 5 years
Local control is the absence of local recurrence during the study period. This is the time from randomization to primary tumour failure or marginal failure.
8 secondary outcomes
Overall Survival
Time frame: 5 years
Disease-Free Survival
Time frame: 5 years
Event-Free Survival
Time frame: 5 years
Lung Cancer-Specific Survival
Time frame: 5 years
Radiation Treatment-Related Death
Time frame: 1 to 12 months
Toxicity
Time frame: 5 years
Quality of Life
Time frame: 2 years
Cost-Utility
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2022.
- Derived from this study: PubMed 41997828Wang Y, Donovan EK, Levine MN, Whelan TJ, Swaminath A, Parpia S; LUSTRE Trial Investigators. Stereotactic Versus Conventional Radiotherapy in Medically Inoperable Stage I Non-Small Cell Lung Cancer: A Bayesian Reanalysis of the LUSTRE Randomized Trial. Clin Lung Cancer. 2026 May;27(4):117-122.e4. doi: 10.1016/j.cllc.2026.03.008. Epub 2026 Mar 26.
- Derived from this study: PubMed 34561039Rosenberg SA, Mak R, Kotecha R, Loo BW Jr, Senan S. The Nordic-HILUS Trial: Ultracentral Lung Stereotactic Ablative Radiotherapy and a Narrow Therapeutic Window. J Thorac Oncol. 2021 Oct;16(10):e79-e80. doi: 10.1016/j.jtho.2021.06.030. No abstract available.
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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. This study is not recruiting at the moment.
Anand Swaminath principal investigator
Ontario Clinical Oncology Group (OCOG)
Tim Whelan principal investigator
Ontario Clinical Oncology Group (OCOG)
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Stereotactic Body Radiotherapy (SBRT) and Conventional Radiotherapy (CRT) in people with Non-small Cell Lung Cancer, run by Ontario Clinical Oncology Group (OCOG) at 16 sites 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 2 inclusion and 11 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: finished, as of the sponsor's last update on 21 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local Control (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01968941, which also lists 2 linked publications.
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 21 Sep 2022.