Stereotactic Body Radiotherapy Versus Conventional Radiotherapy in Medically-Inoperable Non-Small Lung Cancer Patients (LUSTRE)
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.
Non-small Cell Lung Cancer
Radiation: Stereotactic Body Radiotherapy (SBRT)
Radiation: Conventional Radiotherapy (CRT)
|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|
- 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.
- 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
|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)|
Experimental: Stereotactic Body Radiotherapy
Stereotactic Body Radiotherapy (SBRT)
|Radiation: Stereotactic Body Radiotherapy (SBRT)|
Active Comparator: Conventional Radiotherapy
Conventional Radiotherapy (CRT)
|Radiation: Conventional Radiotherapy (CRT)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01968941
|Contact: Kathryn Clinefirstname.lastname@example.org|
|Contact: Sharon Nasonemail@example.com|
|Cancer Care Manitoba||Recruiting|
|Winnipeg, Manitoba, Canada|
|Principal Investigator: Naseer Ahmed|
|Juravinski Hospital and Cancer Centre||Recruiting|
|Hamilton, Ontario, Canada|
|Contact: Anand Swaminath|
|Principal Investigator: Anand Swaminath|
|Niagara Health System-Walker Family Cancer Centre||Recruiting|
|St. Catharines, Ontario, Canada|
|Principal Investigator: Theos Tsakiridis|
|Montreal, Quebec, Canada|
|Principal Investigator: Alexis Bujold|
|Montreal General Hospital McGill||Recruiting|
|Montreal, Quebec, Canada|
|Principal Investigator: Bassam Abdulkarim|
|Saskatoon Cancer Centre||Recruiting|
|Saskatoon, Saskatchewan, Canada|
|Principal Investigator: Vijay Kundapur|
|Principal Investigator:||Anand Swaminath||Ontario Clinical Oncology Group (OCOG)|
|Principal Investigator:||Tim Whelan||Ontario Clinical Oncology Group (OCOG)|