Risk-adapted Stereotactic Body Radiotherapy for Early Non-Small Cell Lung Cancer Using the VERO Stereotactic Body Radio Therapy System

Study Overview
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Brief Summary
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The purpose of this study is to perform prospective data analysis on tumor response in terms of local tumor control after 2 years, potential acute and late toxicity and survival in patients with non-metastatic, non-small-cell lung cancer treated by radiotherapy that are medically inoperable due to coexisting comorbidities or that refuse surgery. SBRT regimens used will be 4 fractions of 12 Gy or 3 fractions of 17 Gy depending on tumor location in a risk-adapted approach.

Official Title
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Phase II Protocol for Risk-adapted Stereotactic Body Radio Therapy for Stage T1-T3N0 Non-Small Cell Lung Carcinoma

Conditions
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Non-Small Cell Lung Carcinoma

Intervention / Treatment
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* Radiation: Radiotherapy (Fractionated stereotactic body radiation)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Stage T1,T2,T3N0M0 NSCLC, histological confirmation either by biopsy or cytology Maximal tumor diameter of 6 cm Only T3 lesions based upon thoracic wall involvement, only 1 lesion Informed consent is required Life expectancy of at least 6 months Age >/= 18 y. Karnofsky score ≥ 70 or ECOG score ≤ 2 Inoperable patients or patients refusing surgery Patients with measurable lesion (according to RECIST criteria) Exclusion Criteria: Diagnosis of small cell lung cancer Lymph node involvement Prior radiotherapy to the chest and/or mediastinum No chemotherapy and/or targeted treatment within 3 months before SBRT Pregnant or lactating women Known allergy for CT contrast No FDG-PET Mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the study. Patient unlikely to comply with protocol, i.e., uncooperative attitude, inability to return for follow-up visits, extreme degradation of lung function tests and patients not likely to complete the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Radiotherapy<br>For centrally located T1 and T2 lesions 4 x 12 Gy over 2 weeks will be delivered. Lesions located peripherally will be treated with 3 x 17 Gy, also delivered within 2 weeks. For both schedules, there should be a minimum of 40 hours and a maximum of 8 days between 2 separate fractions. There should be a maximum of 2 fractions per week. | Radiation: Radiotherapy (Fractionated stereotactic body radiation)<br>* Radiation: Fractionated stereotactic body radiation therapy For centrally located T1 and T2 lesions 4 x 12 Gy over 2 weeks will be delivered. Lesions located peripherally will be treated with 3 x 17Gy, also delivered within 2 weeks. For both schedules, there should be a minimum of 40 hours and a maximum of 8 days between 2 separate fractions. There should be a maximum of 2 fractions per week.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity of grade 3+ as assessed by NCI CTCAE v4.0 | To monitor potential toxicity in patients with stage T1,T2,T3 N0 non-small cell lung carcinoma (NSCLC), treated with primary stereotactic body radiation therapy (SBRT) | From start of SBRT until 1 year. After 1 year until end of follow-up for late toxicity | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to local progression | Overall survival, local progression free survival, disease free survival, time from start of SBRT to death, local, regional or disseminated recurrence. | every 3 months for the first 2 years. From 3 to 5 years every 6 months. After From start of SBRT until date of death, regional fialure of last follow-up. Aanalysis occurs when all patients have been potentially followed for 24 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NSCLC, non-small cell lung cancer, lung carcinoma