Carcinoma, Non-Small-Cell Lung, Neoplasm Metastasis
Conditions
Keywords
Carcinoma, Non-Small-Cell Lung, Neoplasm Metastasis, Radiosurgery
Brief summary
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
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.
Interventions
RADIATION34 Gy in a single fraction
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.
RADIATION54Gy 18Gy/fr. x 3 fractions
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.
RADIATION60Gy (12 x 5 fr.s)
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.
RADIATION60Gy (7.5Gy x 8fr.)
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.
Sponsors
Institut Català d'Oncologia
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| probability of not suffering a grade 3 or higher toxicity | one year | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of acute and late toxicities | One year | To evaluate the frequency of acute and late toxicities. |
| Overall survival | One year | To evaluate the impact of local therapy on overall survival. |
| Tumour response | One year | To evaluate tumour response attending histology with local radiation using imaging such as CT and PET/CT. |
| Effect in brochopulmonary (COPD) disease. | One year | To evaluate the impact of local therapy on bronchopulmonary (COPD) disease. |
| Feasibility | One year | To evaluate the feasibility of this technique in terms of technical complications. |
| Disease-free survival | One year | To evaluate the impact of local therapy on disease-free survival. |
Countries
Spain
Outcome results
None listed