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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A. 34 Gy in a single fraction | Experimental | 34 Gy by single fraction Risk-adapted radiation dose. |
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| B. 54Gy (18Gy/fr. x 3 fractions) | Experimental | 54Gy administered in 3 fraction of 18 Gy, risk adapted radiation dose |
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| C. 50Gy (12 x 5 fr.s) | Experimental | 54Gy administered in 5 fraction of 12 Gy, risk adapted radiation dose |
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| D. 60Gy (7.5Gy x 8fr.) | Experimental | 60 Gy administered in 8 fraction of 7.5 Gy, risk adapted radiation dose |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 34 Gy in a single fraction | Radiation | 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. |
| 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 |
| 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. |
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Inclusion Criteria:
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.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Arturo Navarro-Martin, md | Institut Català d'Oncologia L'Hospitalet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Català d'Oncologia - L'Hospitalet | L'Hospitalet de Llobregat | Barcelona | 08908 | Spain |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| 54Gy 18Gy/fr. x 3 fractions | Radiation | 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. |
|
| 60Gy (12 x 5 fr.s) | Radiation | 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. |
|
| 60Gy (7.5Gy x 8fr.) | Radiation | 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. |
|
| 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 |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |