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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Ontario Clinical Oncology Group (OCOG)
Sponsor:
Collaborator:
Canadian Cancer Society Research Institute (CCSRI)
Information provided by (Responsible Party):
Ontario Clinical Oncology Group (OCOG)
ClinicalTrials.gov Identifier:
NCT01968941
First received: October 21, 2013
Last updated: August 25, 2014
Last verified: August 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. T1/T2a N0 M0 NSCLC, either by: (a) preferably histological confirmation (squamous cell, adenocarcinoma, large cell carcinoma, or not specified) and CT and 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 5 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. Diagnosis of idiopathic pulmonary fibrosis.
  7. Planned for other anticancer therapy (chemotherapy, biological targeted therapy).
  8. Female, who is currently pregnant or lactating.
  9. Geographic inaccessibility for follow-up.
  10. Unable to provide informed consent.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01968941

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

Locations
Canada, Manitoba
Cancer Care Manitoba Not yet recruiting
Winnipeg, Manitoba, Canada
Principal Investigator: Naseer Ahmed         
Canada, Ontario
Juravinski Hospital and Cancer Centre Recruiting
Hamilton, Ontario, Canada
Contact: Anand Swaminath         
Principal Investigator: Anand Swaminath         
Niagara Health System-Walker Family Cancer Centre Not yet recruiting
St. Catharines, Ontario, Canada
Principal Investigator: Theos Tsakiridis         
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

No publications provided

Responsible Party: Ontario Clinical Oncology Group (OCOG)
ClinicalTrials.gov Identifier: NCT01968941     History of Changes
Other Study ID Numbers: OCOG-2013-LUSTRE
Study First Received: October 21, 2013
Last Updated: August 25, 2014
Health Authority: Canada: Ethics Review Committee

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

ClinicalTrials.gov processed this record on September 30, 2014