Status:
WITHDRAWN
Surgery Versus Stereotactic Body Radiation Therapy for Stage up to IA2 (T1a or T1b) Non-small Cell Lung Cancer
Lead Sponsor:
Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Collaborating Sponsors:
CHU de Quebec-Universite Laval
Conditions:
Non-small Cell Lung Cancer Stage I
Surgery
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The primary objective of this study is disease free survival rate at 5 years in stage IA2 (T1aN0M0 or T1bN0M0 only) non-small cell lung cancer (NSCLC) patients treated either by surgery or stereotacti...
Detailed Description
Today, the best medical literature available confirms that surgery is superior to radiation therapy in the treatment of the early stage lung cancer. However, good emerging data demonstrates potential ...
Eligibility Criteria
Inclusion
- Patients aged 18-75
- Pathologically (histologically or cytologically) proven NSCLC.
- Stage IA2 T1aN0M0 or T1bN0M0 only, fit for surgery.
- Tumor ≤ 2 cm (T1a or T1b according to AJCC, 8th ed.)
- Hilar or mediastinal lymph nodes ≤ 1 cm with no abnormal hilar or mediastinal uptake on PET scan are considered N0.
- Patients with hilar or mediastinal lymph nodes \> 1 cm on CT scan or abnormal PET scan (including suspicious but non-diagnostic uptake) are eligible, provided directed tissue biopsies by EBUS or mediastinoscopy of all abnormally identified areas are negative for cancer.
- EBUS preferable
- No regional or distant metastases.
- Resectable disease and treatable by SBRT
- Peripherally located tumor.
- Primary tumor within or touching the zone of the proximal bronchial tree, defined as a volume of 2 cm in all directions around the proximal bronchial tree are excluded (carina, right and left main bronchi, right and left upper lobe bronchi, intermedius bronchus, right middle lobe bronchus, lingular bronchus, right and left lower lobe bronchi).
- No involvement of the central pleura and/or structures of the mediastinum.
- Staging studies must be done within 8 weeks prior to study entry
- Patients must provide study specific informed consent prior to study entry.
Exclusion
- Previously operated lung cancer.
- Previous thoracic irradiation.
- Patients with a history of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer, or other solid tumors curatively treated with no evidence of disease for ≥ 5 years following the end of treatment and which, in the opinion of the treating physician, do not have a substantial risk of recurrence of the prior malignancy.
- Pulmonary nodule manifested as pure ground-glass opacity.
- Severe pulmonary hypertension.
- Severe cardiac, hepatic or renal insufficiency.
- Severe peripheral vascular disease.
- Severe cerebral or psychiatric pathologies.
- Severe chronic heart disease.
- Life expectancy \< 6 months.
- Pregnant or lactating woman.
- Unwilling to have follow-up.
- Central tumor where pneumonectomy might be considered.
Key Trial Info
Start Date :
January 28 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2025
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03431415
Start Date
January 28 2018
End Date
February 1 2025
Last Update
August 24 2021
Active Locations (2)
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1
Hôtel-Dieu de Québec (CHUQ)
Québec, Quebec, Canada, G1R2J6
2
Institut Universitaire de Cardiologie et de Pneumologie de Quebec - Université Laval
Québec, Quebec, Canada, G1V4G5