Status:
UNKNOWN
LungTech: Stereotactic Body Radiotherapy (SBRT) of Inoperable Centrally Located NSCLC
Lead Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Conditions:
Non-small Cell Lung Cancer Stage I
Non-small Cell Lung Cancer Stage II
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Lung cancer is the leading cause of cancer death worldwide with a crude incidence of lung cancer in the European Union of 52/100.000 per year and a mortality of 47/100.000 per year. Non-small-cell lun...
Detailed Description
Conventionally fractionated radiotherapy (RT) has been the standard of care for medically inoperable NSCLC with prescribed doses of usually 60 - 66 Gy.This moderate irradiation regimen resulted in a l...
Eligibility Criteria
Inclusion
- Diagnosis of non-small cell lung cancer (NSCLC), either confirmed by histology or cytology
- Patient deemed medically inoperable after assessment in a multimodality tumor board or refusing surgery
- Tumor size \< 5 cm, or 5-7 cm (strict separate stopping rules will be applied for the latter population)
- Central tumor location i.e. tumor in or abutting a zone within 2 cm of the proximal bronchial tree or other parts of the mediastinum, eligibility of each case underlying expert review
- Staging- whole body FDG-PET/CT acquired within 4 weeks prior to inclusion. In case of uncertainty about affection of hilar/mediastinal nodes, endobronchial ultrasound-transbronchial needle aspiration(EBUS-TBNA) is strongly recommended
- N0 tumors
- T3 tumors only if: not within the mediastinum and not abutting the oesophagus and only one lesion
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- Age ≥ 18 years
- Patients of childbearing / reproductive potential should use adequate birth control measures, as defined by the investigator, during the study treatment period. A highly effective method of birth control is defined as those which result in low failure rate (i.e. less than 1% per year) when used consistently and correctly.
- Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
- Before patient registration, written informed consent must be given according to International Conference on Harmonization /Good Clinical Practice (ICH/GCP), and national/local regulations
Exclusion
- No prior RT of chest and/or mediastinum
- No chemotherapy and/or targeted treatment within 3 months before the onset of RT
Key Trial Info
Start Date :
August 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2021
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT01795521
Start Date
August 1 2015
End Date
July 1 2021
Last Update
January 31 2020
Active Locations (6)
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1
Cliniques Universitaires Saint-Luc
Brussels, Belgium, 1200
2
U.Z. Leuven - Campus Gasthuisberg
Leuven, Belgium, 3000
3
Universitaetsklinikum Freiburg
Freiburg im Breisgau, Germany, 79106
4
Universitaetsklinikum Wuerzburg
Würzburg, Germany, 97080