Risk Adapted SABR(SABR) in Stage I NSCLC And Lung Metastases

Study Overview
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Brief Summary
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This study is designed to evaluate the safety of Stereotactic Ablative Radiotherapy (SBRT) in selected patients with stage I Non Small Cell Lung Cancer (NSCLC) or metastatic lung cancer to demonstrate the feasibility and risks of using an ablative dose-adapted scheme with FFF beams. Other aims are To evaluate the incidence of acute and late complications; To evaluate tumour response to local radiation therapy by means of CT, PET/TC and MRI and To evaluate the impact of local therapy on overall and disease-free survival.

Detailed Description
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The intervention (dose and fractions) depends on topographical parameters: lung disease (primary, peripheral nodes or mediastinal nodes), distance to chest wall, tumour size and distance to main bronchus.

Official Title
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Risk Adapted Free Flattering Filter Based Stereotactic Ablative Radiotherapy (Sabr) in Stage i Nsclc and Lung Metastases

Conditions
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Carcinoma, Non-Small-Cell Lung, Neoplasm Metastasis

Intervention / Treatment
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* Radiation: 34 Gy in a single fraction
* Radiation: 54Gy 18Gy/fr. x 3 fractions
* Radiation: 60Gy (12 x 5 fr.s)
* Radiation: 60Gy (7.5Gy x 8fr.)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically-confirmed primary lung cancer or lung metastasis from another primary tumour or positive PET/CT suggestive for primary tumour(SUV MAX> 4). Tumour size < 5 cm in diameter prior to treatment. Medically inoperable patients as determined by the multidisciplinary thoracic tumour board, or medically operable patients who refuse surgery. Life expectancy of >12 months. Criterion for medical inoperability include: Overall clinical assessment at the UCLA thoracic tumour board. Reduced Pulmonary Function (FEV1, DLCO, etc) based on one major or two minor criterion as described below: Minor Criteria: Age > 75, FEV1 51- 60% predicted, or FEV1 1-1.2L, DLCO 51%-60% predicted, pulmonary hypertension, poor left ventricular function (EF < 40% or less), resting or exercise arterial pO2 < 55 mmHg, and pCO2 > 45 mmHg. Age > 18 years. KPS > 70. Barthel score >40 Baseline computed tomography scans of the chest, pulmonary test function, and positron emission tomography no more than 2 months before treatment. If a woman is of childbearing potential, a negative urine or serum pregnancy test must be documented. Ability to understand and the willingness to sign a written informed consent. Exclusion Criteria: Prior thoracic radiation treatment wich dose contribution can be expected in the new SBRT plan. More than two lesions per lobe. Active infections requiring systemic antibiotics. Age <18 years old. KPs < 70. Barthel Total Score < 40.

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A. 34 Gy in a single fraction<br>34 Gy by single fraction Risk-adapted radiation dose. | Radiation: 34 Gy in a single fraction<br>* 34 Gy in a single fraction in case of Distance to chest wall > 1 cm, tumour size < 2 cm and distance to the main bronchus > 2 cm. STEREOTACTIC ABLATIVE RADIOTHERAPY (SABR) will be administered with volumetric modulated arcs, with photon beam energy of 6-10 MV. The number of arcs and their ballistic is left undefined in order to allow for optimization of the dose distribution. Bolus is not allowed.<br>|
| Experimental: B. 54Gy (18Gy/fr. x 3 fractions)<br>54Gy administered in 3 fraction of 18 Gy, risk adapted radiation dose | Radiation: 54Gy 18Gy/fr. x 3 fractions<br>* 54Gy administered in 3 fractions of 18Gy in case of distance to chest wall > 1 cm, tumour size between 2 and 5 cm and distance to the main bronchus > 2 cm. STEREOTACTIC ABLATIVE RADIOTHERAPY (SABR)will be administered with volumetric modulated arcs, with photon beam energy of 6-10 MV. The number of arcs and their ballistic is left undefined in order to allow for optimization of the dose distribution. Bolus is not allowed.<br>|
| Experimental: C. 50Gy (12 x 5 fr.s)<br>54Gy administered in 5 fraction of 12 Gy, risk adapted radiation dose | Radiation: 60Gy (12 x 5 fr.s)<br>* 50Gy administered in 5 fractions of 12 Gy for Peripheral Nodes in case of distance to chest wall < 1 cm, tumour size < 5 cm and distance to main bronchus > 2 cm. STEREOTACTIC ABLATIVE RADIOTHERAPY (SABR) will be administered with volumetric modulated arcs, with photon beam energy of 6-10 MV. The number of arcs and their ballistic is left undefined in order to allow for optimization of the dose distribution. Bolus is not allowed.<br>|
| Experimental: D. 60Gy (7.5Gy x 8fr.)<br>60 Gy administered in 8 fraction of 7.5 Gy, risk adapted radiation dose | Radiation: 60Gy (7.5Gy x 8fr.)<br>* 60 Gy administered in 8 fractions of 7.5 Gy for mediastinal nodes in case of tumour size < 5 cm and distance to the main bronchus < 2 cm. STEREOTACTIC ABLATIVE RADIOTHERAPY (SABR)will be administered with volumetric modulated arcs, with photon beam energy of 6-10 MV. The number of arcs and their ballistic is left undefined in order to allow for optimization of the dose distribution. Bolus is not allowed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| probability of not suffering a grade 3 or higher toxicity | Patients will be follow-up during one year. If patient suffered any toxicity grade 3 or higher during this period it will be classified as having toxicity. Otherwise patient will be classified as not having toxicity. | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumour response | To evaluate tumour response attending histology with local radiation using imaging such as CT and PET/CT. | One year | 
| Incidence of acute and late toxicities | To evaluate the frequency of acute and late toxicities. | One year | 
| Overall survival | To evaluate the impact of local therapy on overall survival. | One year | 
| Disease-free survival | To evaluate the impact of local therapy on disease-free survival. | One year | 
| Effect in brochopulmonary (COPD) disease. | To evaluate the impact of local therapy on bronchopulmonary (COPD) disease. | One year | 
| Feasibility | To evaluate the feasibility of this technique in terms of technical complications. | One year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Carcinoma, Non-Small-Cell Lung, Neoplasm Metastasis, Radiosurgery