Stereotactic fraktionated radiotherapy in patients with medically inoperable small lung tumors (STRIPE I): a phase II study

Phase 2

• Conditions: C34; C78.0; Malignant neoplasm of bronchus and lung; Secondary malignant neoplasm of lung

• Registration Number: DRKS00003658
• Lead Sponsor: niversitätsklinikum Freiburg, Klinik für Strahlenheilkunde

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04-18
• Study Completion: 2016-11-26
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

presence of one or two FDG-PET positive pulmonary nodules - Karnofsky index >/= 60%
- Life expectancy > 6 months
- Age > 18 years (no other age limits)
- Informed consent signed in accordance with institutional protocol

Exclusion Criteria

- NSCLC: FDG-PET N+ if not ruled out by mediastinoscopy or other tissue sampling
- in metastases: disseminated progressive disease without local control to be reasonably expected by current treatment
- Histologically proven SCLC
- More than two lesions to treat
- Diameter of tumor > 5cm
- Systemic therapy +/- one week of treatment
- psychological/mental status does not allow informed consent and participation in QoL assessments
- Pregnancy

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
local tumor control after two years of follow-up

Secondary Outcome Measures

Name	Time	Method
- actuarial local progression free surviva<br>- overall survival over two years of follow-up<br>- standardized QoL (EORTC QLQ C30 and LC13)<br>- individual QoL (SEIQoL-DW Score)<br>- Toxicity of SR in small lung tumors (CTC score)<br>- Feasibility of integrated cone beam CT for patient positioning in SR<br>- Impact of respiratory gated FDG-PET/CT in SR planning and follow up<br>- Detection of tumor progression by CT vs. FDG-PET