Stereotactic Body Radiotherapy Versus Conventional Radiotherapy in Medically-Inoperable Non-Small Lung Cancer Patients
LUSTRE
A Randomized Trial of Medically-Inoperable Stage 1 Non-small Cell Lung Cancer Patients Comparing Stereotactic Body Radiotherapy Versus Conventional Radiotherapy
1 other identifier
interventional
324
1 country
16
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 nonsmall-cell-lung-cancer
Started May 2014
Longer than P75 for phase_3 nonsmall-cell-lung-cancer
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 21, 2013
CompletedFirst Posted
Study publicly available on registry
October 24, 2013
CompletedStudy Start
First participant enrolled
May 7, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2022
CompletedSeptember 21, 2022
September 1, 2022
7.8 years
October 21, 2013
September 19, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
5 years
Secondary Outcomes (8)
Overall Survival
5 years
Disease-Free Survival
5 years
Event-Free Survival
5 years
Lung Cancer-Specific Survival
5 years
Radiation Treatment-Related Death
1 to 12 months
- +3 more secondary outcomes
Study Arms (2)
Stereotactic Body Radiotherapy
EXPERIMENTALStereotactic Body Radiotherapy (SBRT)
Conventional Radiotherapy
ACTIVE COMPARATORConventional Radiotherapy (CRT)
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
Tom Baker Cancer Centre
Calgary, Alberta, Canada
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2, Canada
Cancer Care Manitoba
Winnipeg, Manitoba, Canada
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, K7L 2V7, Canada
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, J4V 2H1, Canada
CHUM Hospital Notre Dame
Montreal, Quebec, Canada
Hôpital Maisonneuve-Rosemont
Montreal, Quebec, Canada
Montreal General Hospital McGill
Montreal, Quebec, Canada
Allan Blair Cancer Centre
Regina, Saskatchewan, S4T 7T1, Canada
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, Canada
Related Publications (1)
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: 34561039DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anand Swaminath
Ontario Clinical Oncology Group (OCOG)
- PRINCIPAL INVESTIGATOR
Tim Whelan
Ontario Clinical Oncology Group (OCOG)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 21, 2013
First Posted
October 24, 2013
Study Start
May 7, 2014
Primary Completion
February 28, 2022
Study Completion
May 1, 2022
Last Updated
September 21, 2022
Record last verified: 2022-09