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

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: Non-small Cell Lung Cancer
• Intervention / Treatment: Radiation: Stereotactic Body Radiotherapy (SBRT); Radiation: Conventional Radiotherapy (CRT)

• Study Type: Interventional
• Enrollment (Anticipated): 324
• Phase: Phase 3

Contacts and Locations

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
      • Hôpital 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

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

How is the study designed?

Design Details

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

Number of Arms

2

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	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	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	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	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	Lung Cancer-Specific Survival is defined as the time from randomization to death attributable to lung cancer	5 years
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	1 to 12 months
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.	5 years
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.	2 years
Cost-Utility	Cost-Utility will be assessed using the European Quality of Life questionnaire in conjunction with the overall survival results	3 years

Collaborators and Investigators

• 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

General Publications

• 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.

Study record dates

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: survival; stereotactic body radiotherapy; cancer recurrence; toxicity; conventional radiotherapy; local control; inoperable patients
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• 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