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

September 19, 2022 updated by: Ontario Clinical Oncology Group (OCOG)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

324

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada
        • Tom Baker Cancer Centre
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Cross Cancer Institute
    • Manitoba
      • Winnipeg, Manitoba, Canada
        • Cancer Care Manitoba
    • New Brunswick
      • Saint John, New Brunswick, Canada
        • Horizon Health Network
    • Ontario
      • Hamilton, Ontario, Canada
        • Juravinski Hospital and Cancer Centre
      • Kingston, Ontario, Canada, K7L 2V7
        • Cancer Centre of Southeastern Ontario at the Kingston General Hospital
      • London, Ontario, Canada
        • London Regional Cancer Program at London Health Sciences Centre
      • St. Catharines, Ontario, Canada
        • Niagara Health System-Walker Family Cancer Centre
      • Thunder Bay, Ontario, Canada
        • Thunder Bay Regional Health Sciences Centre
      • Windsor, Ontario, Canada
        • Windsor Regional Cancer Centre
    • Quebec
      • Greenfield Park, Quebec, Canada, J4V 2H1
        • Charles LeMoyne Hospital
      • Montreal, Quebec, Canada
        • Hopital Maisonneuve-Rosemont
      • Montreal, Quebec, Canada
        • Chum Hospital Notre Dame
      • Montreal, Quebec, Canada
        • Montreal General Hospital McGill
    • Saskatchewan
      • Regina, Saskatchewan, Canada, S4T 7T1
        • Allan Blair Cancer Centre
      • Saskatoon, Saskatchewan, Canada
        • Saskatoon Cancer Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Stereotactic Body Radiotherapy
Stereotactic Body Radiotherapy (SBRT)
Radiation: Stereotactic Body Radiotherapy (SBRT)
ACTIVE_COMPARATOR: Conventional Radiotherapy
Conventional Radiotherapy (CRT)
Radiation: Conventional Radiotherapy (CRT)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
5 years
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.
5 years
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.
5 years
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
5 years
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
1 to 12 months
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.
5 years
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.
2 years
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
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ontario Clinical Oncology Group (OCOG)

Collaborators

Canadian Cancer Society (CCS)

Investigators

  • Principal Investigator: Anand Swaminath, Ontario Clinical Oncology Group (OCOG)
  • Principal Investigator: Tim Whelan, Ontario Clinical Oncology Group (OCOG)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 7, 2014

Primary Completion (ACTUAL)

February 28, 2022

Study Completion (ACTUAL)

May 1, 2022

Study Registration Dates

First Submitted

October 21, 2013

First Submitted That Met QC Criteria

October 21, 2013

First Posted (ESTIMATE)

October 24, 2013

Study Record Updates

Last Update Posted (ACTUAL)

September 21, 2022

Last Update Submitted That Met QC Criteria

September 19, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OCOG-2013-LUSTRE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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