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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
67
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.
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.
Institut Català d'Oncologia - L'Hospitalet
L'Hospitalet de Llobregat, Barcelona, Spain
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.
Time frame: one year
Tumour response
To evaluate tumour response attending histology with local radiation using imaging such as CT and PET/CT.
Time frame: One year
Incidence of acute and late toxicities
To evaluate the frequency of acute and late toxicities.
Time frame: One year
Overall survival
To evaluate the impact of local therapy on overall survival.
Time frame: One year
Disease-free survival
To evaluate the impact of local therapy on disease-free survival.
Time frame: One year
Effect in brochopulmonary (COPD) disease.
To evaluate the impact of local therapy on bronchopulmonary (COPD) disease.
Time frame: One year
Feasibility
To evaluate the feasibility of this technique in terms of technical complications.
Time frame: One year
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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.
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.