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NCT Number: NCT01968941

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

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.

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Tom Baker Cancer Centre, Calgary, Alberta, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Stereotactic body radiotherapy (SBRT)

Radiation

Conventional Radiotherapy (CRT)

Radiation

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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. 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

  6. 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.

  7. 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.

  8. 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

Sponsors and collaborators

Lead sponsor

Ontario Clinical Oncology Group (OCOG)

Other

Collaborators

  • Canadian Cancer Society (CCS)

Registry information

Official study title

A Randomized Trial of Medically-Inoperable Stage 1 Non-small Cell Lung Cancer Patients Comparing Stereotactic Body Radiotherapy Versus Conventional Radiotherapy

Acronym: LUSTRE

Important dates

Study start
2014
Primary completion
2022
Study completion
2022
First posted
Oct 24, 2013
Registry last updated
Sep 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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