Status:
UNKNOWN
Risk-adapted Stereotactic Body Radiotherapy for Early Non-Small Cell Lung Cancer Using the VERO Stereotactic Body Radio Therapy System
Lead Sponsor:
Universitair Ziekenhuis Brussel
Conditions:
Non-Small Cell Lung Carcinoma
Eligibility:
All Genders
18-90 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to perform prospective data analysis on tumor response in terms of local tumor control after 2 years, potential acute and late toxicity and survival in patients with non-m...
Eligibility Criteria
Inclusion
- Stage T1,T2,T3N0M0 NSCLC, histological confirmation either by biopsy or cytology
- Maximal tumor diameter of 6 cm
- Only T3 lesions based upon thoracic wall involvement, only 1 lesion
- Informed consent is required
- Life expectancy of at least 6 months
- Age \>/= 18 y.
- Karnofsky score ≥ 70 or ECOG score ≤ 2
- Inoperable patients or patients refusing surgery
- Patients with measurable lesion (according to RECIST criteria)
Exclusion
- Diagnosis of small cell lung cancer
- Lymph node involvement
- Prior radiotherapy to the chest and/or mediastinum
- No chemotherapy and/or targeted treatment within 3 months before SBRT
- Pregnant or lactating women
- Known allergy for CT contrast
- No FDG-PET
- Mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the study.
- Patient unlikely to comply with protocol, i.e., uncooperative attitude, inability to return for follow-up visits, extreme degradation of lung function tests and patients not likely to complete the study.
Key Trial Info
Start Date :
January 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT02224547
Start Date
January 1 2013
Last Update
September 9 2014
Active Locations (1)
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1
UZ Brussel Radiotherapie dienst
Jette, Brussels Capital, Belgium, 1090