Non-small Cell Lung Cancer
Conditions
Keywords
stereotactic body radiotherapy, conventional radiotherapy, inoperable patients, local control, cancer recurrence, toxicity, survival
Brief summary
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.
Interventions
RADIATIONStereotactic Body Radiotherapy (SBRT)
RADIATIONConventional Radiotherapy (CRT)
Sponsors
Canadian Cancer Society (CCS)
Ontario Clinical Oncology Group (OCOG)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Local Control | 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
| Measure | Time frame | Description |
|---|---|---|
| Disease-Free Survival | 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 | 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 | 5 years | Lung Cancer-Specific Survival is defined as the time from randomization to death attributable to lung cancer |
| Overall Survival | 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. |
| Toxicity | 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 | 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 | 3 years | Cost-Utility will be assessed using the European Quality of Life questionnaire in conjunction with the overall survival results |
| Radiation Treatment-Related Death | 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 |
Countries
Canada
Outcome results
None listed