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NCT01968941 · CITED IN SOURCE DOCUMENTS

Stereotactic Body Radiotherapy Versus Conventional Radiotherapy in Medically-Inoperable Non-Small Lung Cancer Patients

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE3
Status at capture
COMPLETED
Registry last update
2022-09-21

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part
eligibility Criteria
Inclusion Criteria: 1. 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. 2. 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. Exclusion Criteria: 1. Less than 18 years of age. 2. Eastern Cooperative Oncology Group (ECOG) performance status 3 or higher. 3. Prior invasive malignancy within the past 3 years (excluding non-melanomatous skin cancer). 4. History of ataxia telangiectasia. 5. Previous radiotherapy (RT) in the vicinity of the tumour, such that significant overlap could occur. 6. Previous pneumonectomy with Stage I lung cancer in the remaining lung. 7. Diagnosis of idiopathic pulmonary fibrosis and/or interstitial lung disease. 8. Planned for other anticancer therapy (chemotherapy, biological targeted therapy). 9. Female, who is currently pregnant or lactating. 10. Geographic inaccessibility for follow-up. 11. Unable to provide informed consent.
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Stereotactic Body Radiotherapy (SBRT)
    intervention Names
    1. Radiation: Stereotactic Body Radiotherapy (SBRT)
    label
    Stereotactic Body Radiotherapy
    type
    EXPERIMENTAL
  2. description
    Conventional Radiotherapy (CRT)
    intervention Names
    1. Radiation: Conventional Radiotherapy (CRT)
    label
    Conventional Radiotherapy
    type
    ACTIVE_COMPARATOR
interventions
  1. arm Group Labels
    1. Stereotactic Body Radiotherapy
    name
    Stereotactic Body Radiotherapy (SBRT)
    type
    RADIATION
  2. arm Group Labels
    1. Conventional Radiotherapy
    name
    Conventional Radiotherapy (CRT)
    type
    RADIATION
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
324
type
ESTIMATED
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    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.
    measure
    Local Control
    time Frame
    5 years
secondary Outcomes
  1. description
    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.
    measure
    Overall Survival
    time Frame
    5 years
  2. description
    Disease-Free Survival is defined as the time from randomization to the earliest recurrence of disease or to death attributed to lung cancer.
    measure
    Disease-Free Survival
    time Frame
    5 years
  3. description
    Event-Free Survival is defined as the time from randomization to the earliest documented recurrent disease or death from any cause.
    measure
    Event-Free Survival
    time Frame
    5 years
  4. description
    Lung Cancer-Specific Survival is defined as the time from randomization to death attributable to lung cancer
    measure
    Lung Cancer-Specific Survival
    time Frame
    5 years
  5. description
    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
    measure
    Radiation Treatment-Related Death
    time Frame
    1 to 12 months
  6. description
    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.
    measure
    Toxicity
    time Frame
    5 years
  7. description
    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.
    measure
    Quality of Life
    time Frame
    2 years
  8. description
    Cost-Utility will be assessed using the European Quality of Life questionnaire in conjunction with the overall survival results
    measure
    Cost-Utility
    time Frame
    3 years
Full study description
brief 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. 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.
Source references
references
  1. citation
    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.
    pmid
    41997828
    type
    DERIVED
  2. citation
    Rosenberg 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.
    pmid
    34561039
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
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        </li></ol></div> <p id="_484640" tabindex="-1">A randomized trial of hypofractionated radiation therapy versus SBRT (LUSTRE [<a href="/clinicaltrials/NCT01968941">NCT01968941</a>]) is ongoing to determine the optimal radiation therapy regimen, but SBRT has been widely adopted for patients with medically inoperable stage
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        iv> <p id="_484640" tabindex="-1">A randomized trial of hypofractionated radiation therapy versus SBRT (LUSTRE [<a href="/clinicaltrials/NCT01968941">NCT01968941</a>]) is ongoing to determine the optimal radiation therapy regimen, but SBRT has been widely adopted for patients with medically inoperable stage I NSCLC.</p>
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      source retrieved at
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      source string sha256
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      source title
      Non-Small Cell Lung Cancer Treatment (PDQ®)–Health Professional Version
      source update dates
      1. context
        Updated: May 15, 2025
        datetime
        2025-05-15T12:00:00Z
        display
        May 15, 2025

    Preserved source evidence · Not medical advice