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

This study is currently recruiting participants.
Verified July 2017 by Ontario Clinical Oncology Group (OCOG)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01968941
First Posted: October 24, 2013
Last Update Posted: July 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Canadian Cancer Society Research Institute (CCSRI)
Information provided by (Responsible Party):
Ontario Clinical Oncology Group (OCOG)
  Purpose
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.

Condition Intervention Phase
Non-small Cell Lung Cancer Radiation: Stereotactic Body Radiotherapy (SBRT) Radiation: Conventional Radiotherapy (CRT) Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Trial of Medically-Inoperable Stage 1 Non-small Cell Lung Cancer Patients Comparing Stereotactic Body Radiotherapy Versus Conventional Radiotherapy

Resource links provided by NLM:


Further study details as provided by Ontario Clinical Oncology Group (OCOG):

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.

  • 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.

  • 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.

  • 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

  • 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

  • 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.

  • 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.

  • 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


Estimated Enrollment: 324
Study Start Date: February 2014
Estimated Study Completion Date: April 2019
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Stereotactic Body Radiotherapy
Stereotactic Body Radiotherapy (SBRT)
Radiation: Stereotactic Body Radiotherapy (SBRT)
Active Comparator: Conventional Radiotherapy
Conventional Radiotherapy (CRT)
Radiation: Conventional Radiotherapy (CRT)

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01968941


Contacts
Contact: Kathryn Cline clinek@mcmaster.ca
Contact: Sharon Nason nasons@mcmaster.ca

Locations
Canada, Alberta
Tom Baker Cancer Centre Recruiting
Calgary, Alberta, Canada
Principal Investigator: Harold Lau         
Cross Cancer Institute Recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Principal Investigator: Zsolt Gabos         
Canada, British Columbia
BCCA Vancouver Island Cancer Centre Withdrawn
Victoria, British Columbia, Canada
Canada, Manitoba
Cancer Care Manitoba Recruiting
Winnipeg, Manitoba, Canada
Principal Investigator: Naseer Ahmed         
Canada, New Brunswick
Horizon Health Network Recruiting
Saint John, New Brunswick, Canada
Principal Investigator: Amanda Caissie         
Canada, Ontario
Juravinski Hospital and Cancer Centre Recruiting
Hamilton, Ontario, Canada
Contact: Anand Swaminath         
Principal Investigator: Anand Swaminath         
Cancer Centre of Southeastern Ontario at the Kingston General Hospital Recruiting
Kingston, Ontario, Canada, K7L 2V7
Principal Investigator: Timothy Owen         
London Regional Cancer Program at London Health Sciences Centre Recruiting
London, Ontario, Canada
Principal Investigator: Alexander Louie         
Niagara Health System-Walker Family Cancer Centre Recruiting
St. Catharines, Ontario, Canada
Principal Investigator: Theos Tsakiridis         
Thunder Bay Regional Health Sciences Centre Recruiting
Thunder Bay, Ontario, Canada
Principal Investigator: Kevin Ramchandar         
Windsor Regional Cancer Centre Recruiting
Windsor, Ontario, Canada
Principal Investigator: Khalid Hirmiz         
Canada, Quebec
CHUM Hospital Notre Dame Recruiting
Montreal, Quebec, Canada
Principal Investigator: Marie-Pierre Campeau         
Hôpital Maisonneuve-Rosemont Recruiting
Montreal, Quebec, Canada
Principal Investigator: Alexis Bujold         
Montreal General Hospital McGill Recruiting
Montreal, Quebec, Canada
Principal Investigator: Bassam Abdulkarim         
Canada, Saskatchewan
Allan Blair Cancer Centre Recruiting
Regina, Saskatchewan, Canada, S4T 7T1
Principal Investigator: Nelson Leong         
Saskatoon Cancer Centre Recruiting
Saskatoon, Saskatchewan, Canada
Principal Investigator: Vijay Kundapur         
Sponsors and Collaborators
Ontario Clinical Oncology Group (OCOG)
Canadian Cancer Society Research Institute (CCSRI)
Investigators
Principal Investigator: Anand Swaminath Ontario Clinical Oncology Group (OCOG)
Principal Investigator: Tim Whelan Ontario Clinical Oncology Group (OCOG)
  More Information

Responsible Party: Ontario Clinical Oncology Group (OCOG)
ClinicalTrials.gov Identifier: NCT01968941     History of Changes
Other Study ID Numbers: OCOG-2013-LUSTRE
First Submitted: October 21, 2013
First Posted: October 24, 2013
Last Update Posted: July 28, 2017
Last Verified: July 2017

Keywords provided by Ontario Clinical Oncology Group (OCOG):
stereotactic body radiotherapy
conventional radiotherapy
inoperable patients
local control
cancer recurrence
toxicity
survival

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms