Protocol for Primary Fractionated Stereotactic Body Radiation Therapy for Stage T1 - T3N0 Non Small Cell Lung Carcinoma.

Study Overview
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Brief Summary
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The study population will exist of patients with a histological diagnosis of NSCLC, stage T1, T2 or T3NO who are not fit for or who refuse surgery. A prospective data analysis will be performed on tumor response, potential acute and late toxicity and survival. A radiotherapy dose of 4x15Gy or 3x 20Gy will be given over 2 weeks with dynamic 3D-conformal arc therapy (Novalis TM)

Official Title
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Phase II Protocol for Primary Fractionated Stereotactic Body Radiation 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: Fractionated stereotactic body radiation therapy


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 Informed consent is required Life expectancy of at least 6 months Age > 18 y. Karnofsky score ≥ 70 or ECOG score ≤ 1 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 or chemotherapy for lung cancer 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

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>For centrally located T1 and T2 lesions 4 x 15 Gy over 2 weeks will be delivered. Lesions located peripherally will be treated with 3 x 20 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: Fractionated stereotactic body radiation therapy<br>* For centrally located T1 and T2 lesions 4 x 15 Gy over 2 weeks will be delivered. Lesions located peripherally will be treated with 3 x 20 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To monitor potential acute and late toxicity in patients with stage T1,T2,T3N0 non small cell lung carcinoma (NSCLC), treated with primary stereotactic body radiation therapy (SBRT). |  | Every 3 months for the first 2 years. From 3 to 5 years every 6 months. After 5 years follow-up will happen yearly. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local control at 2 years. Overall survival, local progression free survival, disease free survival, time to progression and local,regional or disseminated recurrence.Quality of life. Internal and Intra-fractional tumor motion. Biopsy samples. |  | Every 3 months for the first 2 years. From 3 to 5 years every 6 months. After 5 years follow-up will happen yearly. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NSCLC, Novalis, Stereotactic, SBRT, T1, T2 or T3NO NSCLC