Surgery Versus Stereotactic Body Radiation Therapy for Stage up to IA2 (T1a or T1b) Non-small Cell Lung Cancer

Study Overview
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Brief Summary
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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 stereotactic body radiation therapy (SBRT).

Detailed Description
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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 equality between these two treatments. Two major international studies have tried to compare both treatments but have failed to complete the study because of the lack of patients accrual. We chose to design a trial in which patients will be part of a shared decision making process in selecting the treatment modality. Patients with early stage lung cancer, that can undergo surgical treatment will be offered SBRT, and in conjunction with the pulmonologist will decide which treatment they prefer. We intend to complete the recruitment of patients within 02 years, then follow-up for 5 more years to collect data.

Official Title
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Surgery Versus Stereotactic Body Radiation Therapy for Stage up to IA2 (T1a or T1b) Non-small Cell Lung Cancer

Conditions
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Surgery, Non-small Cell Lung Cancer Stage I, Stereotactic Body Radiation Therapy

Intervention / Treatment
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* Procedure: Anatomical Segmentectomy, Lobectomy or Bilobectomy
* Radiation: Stereotactic Body Radiation Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Surgery<br>Patients that will undergo surgery (anatomical segmentectomy, lobectomy or bilobectomy) as primary lung cancer treatment | Procedure: Anatomical Segmentectomy, Lobectomy or Bilobectomy<br>* Lung Cancer Anatomical Resection<br>|
| Active Comparator: SBRT (Stereotactic Body Radiation Therapy)<br>Patients that will undergo SBRT as primary lung cancer treatment | Radiation: Stereotactic Body Radiation Therapy<br>* SBRT treatment. 48Gy in 4 sessions for peripheral lesions and 50Gy in 5 sessions for central lesions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease free survival | To compare the disease free survival of patients with Stage up to IA2 (T1aN0M0 or T1bN0M0) NSCLC managed either by SBRT or surgery. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival | Overall survival rate at 5 years in both arms | 5 years | 
| Level of morbidity | Level of morbidity in both arms (CTCAE 4.0 - common toxicity criteria) | 5 years | 
| Level of efficacy in the SBRT arm | Level of efficacy in the SBRT arm (RECIST 1.1) | 5 years | 
| QOL assessment | QOL assessment with SF36 questionnaire (pre and post treatment) in both arms | 5 years | 
| FEV1 and DLCO decline at 1-year post-treatment in both arms | FEV1 or DLCO decline at 1-year post-treatment in both arms | 1 year | 
| Health economic evaluation in both arms | Health economic evaluation in both arms | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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VATS, Lung, Cancer, Early-Stage, Video-assisted Thoracic Surgery, SBRT, Stereotactic Body Radiation Therapy