ungtech-RETRO Evaluation of stereotactic body radiation therapy (SBRT) of centrally located lung tumors

Recruiting

• Conditions: C34; Malignant neoplasm of bronchus and lung

• Registration Number: DRKS00033981
• Lead Sponsor: Klinik für Strahlentherapie und Radioonkologie der Universitätsklinik Bonn

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-25
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

SBRT for centrally located early-stage NSCLC or central lung metastasis
- Lesions in which a malignant tumor has been confirmed either by histology/cytology or by clear imaging evidence (suspected CT, growth, FDG scan)
- No previous radiotherapy of the thorax and/or mediastinum
- BED of at least 70 Gy (a/ß= 10; at least EQD-2 = 62.5 Gy) with highly conformal, image-guided radiotherapy technique
- Any fractionation is acceptable as long as the BED is 70 Gy or more (EQD-2 = 62.5 Gy)

Exclusion Criteria

- SBRT of peripheral tumors
- Pre-irradiation of the thorax and/or mediastinum
- Biologically effective dose (BED) of less than 70 Gy (a/ß= 10; minimum EQD-2 = 62.5 Gy)

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primäry endpoint is acute (<90 day after end of SBRT) and late (>= 90 days after end of SBRT) toxicity according to CTCAE version 5.

Secondary Outcome Measures

Name	Time	Method
freedom from local progression 3 years after SBRT<br>local and distant recurrence<br>local progression-free survival<br>overall survival and cause of death<br>dose-effect correlation