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

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

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
DRKS
Registry ID
DRKS00003658
Enrollment
100
Registered
2012-04-18
Start date
2011-02-15
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C34 C78.0

Interventions

Group 1: stereotactic fractionated radiotherapy of small lung tumors in 3 to 5 fractions

Sponsors

Universitätsklinikum Freiburg, Klinik für Strahlenheilkunde
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
local tumor control after two years of follow-up

Secondary

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

Countries

Germany

Contacts

Public ContactUrsula Nestle

Universitätsklinikum Freiburg, Klinik für Strahlenheilkunde

stripe@uniklinik-freiburg.de076127094010

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026