NCT01823003

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

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 67 (estimated)
• Sponsor: Institut Català d'Oncologia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
RADIATION	34 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.
RADIATION	54Gy 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.
RADIATION	60Gy (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.
RADIATION	60Gy (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.

Timeline

• Start date: 2012-06-01
• Primary completion: 2019-12-01
• Completion: 2020-07-01
• First posted: 2013-04-04
• Last updated: 2019-08-07

Locations

1 site across 1 country: Spain