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

Primary Purpose

Non-small Cell Lung Cancer

Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Stereotactic Body Radiotherapy (SBRT)
Conventional Radiotherapy (CRT)
Sponsored by
Ontario Clinical Oncology Group (OCOG)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring stereotactic body radiotherapy, conventional radiotherapy, inoperable patients, local control, cancer recurrence, toxicity, survival

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Tom Baker Cancer Centre
  • Cross Cancer Institute
  • Cancer Care Manitoba
  • Horizon Health Network
  • Juravinski Hospital and Cancer Centre
  • Cancer Centre of Southeastern Ontario at the Kingston General Hospital
  • London Regional Cancer Program at London Health Sciences Centre
  • Niagara Health System-Walker Family Cancer Centre
  • Thunder Bay Regional Health Sciences Centre
  • Windsor Regional Cancer Centre
  • Charles LeMoyne Hospital
  • CHUM Hospital Notre Dame
  • Hôpital Maisonneuve-Rosemont
  • Montreal General Hospital McGill
  • Allan Blair Cancer Centre
  • Saskatoon Cancer Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Stereotactic Body Radiotherapy

Conventional Radiotherapy

Arm Description

Stereotactic Body Radiotherapy (SBRT)

Conventional Radiotherapy (CRT)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
Event-Free Survival
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
Lung Cancer-Specific Survival is defined as the time from randomization to death attributable to lung cancer
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
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.
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.
Cost-Utility
Cost-Utility will be assessed using the European Quality of Life questionnaire in conjunction with the overall survival results

Full Information

First Posted
October 21, 2013
Last Updated
September 19, 2022
Sponsor
Ontario Clinical Oncology Group (OCOG)
Collaborators
Canadian Cancer Society (CCS)
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1. Study Identification

Unique Protocol Identification Number
NCT01968941
Brief Title
Stereotactic Body Radiotherapy Versus Conventional Radiotherapy in Medically-Inoperable Non-Small Lung Cancer Patients
Acronym
LUSTRE
Official Title
A Randomized Trial of Medically-Inoperable Stage 1 Non-small Cell Lung Cancer Patients Comparing Stereotactic Body Radiotherapy Versus Conventional Radiotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
May 7, 2014 (Actual)
Primary Completion Date
February 28, 2022 (Actual)
Study Completion Date
May 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ontario Clinical Oncology Group (OCOG)
Collaborators
Canadian Cancer Society (CCS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer
Keywords
stereotactic body radiotherapy, conventional radiotherapy, inoperable patients, local control, cancer recurrence, toxicity, survival

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
324 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Stereotactic Body Radiotherapy
Arm Type
Experimental
Arm Description
Stereotactic Body Radiotherapy (SBRT)
Arm Title
Conventional Radiotherapy
Arm Type
Active Comparator
Arm Description
Conventional Radiotherapy (CRT)
Intervention Type
Radiation
Intervention Name(s)
Stereotactic Body Radiotherapy (SBRT)
Intervention Type
Radiation
Intervention Name(s)
Conventional Radiotherapy (CRT)
Primary Outcome Measure Information:
Title
Local Control
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.
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Overall Survival
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.
Time Frame
5 years
Title
Disease-Free Survival
Description
Disease-Free Survival is defined as the time from randomization to the earliest recurrence of disease or to death attributed to lung cancer.
Time Frame
5 years
Title
Event-Free Survival
Description
Event-Free Survival is defined as the time from randomization to the earliest documented recurrent disease or death from any cause.
Time Frame
5 years
Title
Lung Cancer-Specific Survival
Description
Lung Cancer-Specific Survival is defined as the time from randomization to death attributable to lung cancer
Time Frame
5 years
Title
Radiation Treatment-Related Death
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
Time Frame
1 to 12 months
Title
Toxicity
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.
Time Frame
5 years
Title
Quality of Life
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.
Time Frame
2 years
Title
Cost-Utility
Description
Cost-Utility will be assessed using the European Quality of Life questionnaire in conjunction with the overall survival results
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anand Swaminath
Organizational Affiliation
Ontario Clinical Oncology Group (OCOG)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tim Whelan
Organizational Affiliation
Ontario Clinical Oncology Group (OCOG)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tom Baker Cancer Centre
City
Calgary
State/Province
Alberta
Country
Canada
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
Cancer Care Manitoba
City
Winnipeg
State/Province
Manitoba
Country
Canada
Facility Name
Horizon Health Network
City
Saint John
State/Province
New Brunswick
Country
Canada
Facility Name
Juravinski Hospital and Cancer Centre
City
Hamilton
State/Province
Ontario
Country
Canada
Facility Name
Cancer Centre of Southeastern Ontario at the Kingston General Hospital
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 2V7
Country
Canada
Facility Name
London Regional Cancer Program at London Health Sciences Centre
City
London
State/Province
Ontario
Country
Canada
Facility Name
Niagara Health System-Walker Family Cancer Centre
City
St. Catharines
State/Province
Ontario
Country
Canada
Facility Name
Thunder Bay Regional Health Sciences Centre
City
Thunder Bay
State/Province
Ontario
Country
Canada
Facility Name
Windsor Regional Cancer Centre
City
Windsor
State/Province
Ontario
Country
Canada
Facility Name
Charles LeMoyne Hospital
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2H1
Country
Canada
Facility Name
CHUM Hospital Notre Dame
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Hôpital Maisonneuve-Rosemont
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Montreal General Hospital McGill
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Allan Blair Cancer Centre
City
Regina
State/Province
Saskatchewan
ZIP/Postal Code
S4T 7T1
Country
Canada
Facility Name
Saskatoon Cancer Centre
City
Saskatoon
State/Province
Saskatchewan
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
34561039
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.
Results Reference
derived

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

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