Stereotactic Body Radiotherapy Versus Conventional Radiotherapy in Medically-Inoperable Non-Small Lung Cancer Patients (LUSTRE)
|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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01968941|
Recruitment Status : Completed
First Posted : October 24, 2013
Last Update Posted : September 21, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Non-small Cell Lung Cancer||Radiation: Stereotactic Body Radiotherapy (SBRT) Radiation: Conventional Radiotherapy (CRT)||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||324 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Trial of Medically-Inoperable Stage 1 Non-small Cell Lung Cancer Patients Comparing Stereotactic Body Radiotherapy Versus Conventional Radiotherapy|
|Actual Study Start Date :||May 7, 2014|
|Actual Primary Completion Date :||February 28, 2022|
|Actual Study Completion Date :||May 2022|
Experimental: Stereotactic Body Radiotherapy
Stereotactic Body Radiotherapy (SBRT)
Radiation: Stereotactic Body Radiotherapy (SBRT)
Active Comparator: Conventional Radiotherapy
Conventional Radiotherapy (CRT)
Radiation: Conventional Radiotherapy (CRT)
- 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.
- Overall Survival [ Time Frame: 5 years ]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.
- Disease-Free Survival [ Time Frame: 5 years ]Disease-Free Survival is defined as the time from randomization to the earliest recurrence of disease or to death attributed to lung cancer.
- Event-Free Survival [ Time Frame: 5 years ]Event-Free Survival is defined as the time from randomization to the earliest documented recurrent disease or death from any cause.
- Lung Cancer-Specific Survival [ Time Frame: 5 years ]Lung Cancer-Specific Survival is defined as the time from randomization to death attributable to lung cancer
- Radiation Treatment-Related Death [ Time Frame: 1 to 12 months ]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
- Toxicity [ Time Frame: 5 years ]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.
- Quality of Life [ Time Frame: 2 years ]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.
- Cost-Utility [ Time Frame: 3 years ]Cost-Utility will be assessed using the European Quality of Life questionnaire in conjunction with the overall survival results
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
- 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.
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): NCT01968941
|Tom Baker Cancer Centre|
|Calgary, Alberta, Canada|
|Cross Cancer Institute|
|Edmonton, Alberta, Canada, T6G 1Z2|
|Cancer Care Manitoba|
|Winnipeg, Manitoba, Canada|
|Canada, New Brunswick|
|Horizon Health Network|
|Saint John, New Brunswick, Canada|
|Juravinski Hospital and Cancer Centre|
|Hamilton, Ontario, Canada|
|Cancer Centre of Southeastern Ontario at the Kingston General Hospital|
|Kingston, Ontario, Canada, K7L 2V7|
|London Regional Cancer Program at London Health Sciences Centre|
|London, Ontario, Canada|
|Niagara Health System-Walker Family Cancer Centre|
|St. Catharines, Ontario, Canada|
|Thunder Bay Regional Health Sciences Centre|
|Thunder Bay, Ontario, Canada|
|Windsor Regional Cancer Centre|
|Windsor, Ontario, Canada|
|Charles LeMoyne Hospital|
|Greenfield Park, Quebec, Canada, J4V 2H1|
|CHUM Hospital Notre Dame|
|Montreal, Quebec, Canada|
|Montreal, Quebec, Canada|
|Montreal General Hospital McGill|
|Montreal, Quebec, Canada|
|Allan Blair Cancer Centre|
|Regina, Saskatchewan, Canada, S4T 7T1|
|Saskatoon Cancer Centre|
|Saskatoon, Saskatchewan, Canada|
|Principal Investigator:||Anand Swaminath||Ontario Clinical Oncology Group (OCOG)|
|Principal Investigator:||Tim Whelan||Ontario Clinical Oncology Group (OCOG)|
|Responsible Party:||Ontario Clinical Oncology Group (OCOG)|
|Other Study ID Numbers:||
|First Posted:||October 24, 2013 Key Record Dates|
|Last Update Posted:||September 21, 2022|
|Last Verified:||September 2022|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
stereotactic body radiotherapy
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Neoplasms by Site
Respiratory Tract Diseases