Risk-adapted Stereotactic Body Radiotherapy for Early Non-Small Cell Lung Cancer Using the VERO Stereotactic Body Radio Therapy System
Conditions
Non-Small Cell Lung Carcinoma
Conditions: official terms
Carcinoma - Carcinoma, Non-Small-Cell Lung - Lung Neoplasms
Conditions: Keywords
non-small cell lung cancer, lung carcinoma, NSCLC
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Radiotherapy (Fractionated stereotactic body radiation)
Type: Radiation
Overall Status
Recruiting
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-metastatic, non-small-cell lung cancer treated by radiotherapy that are medically inoperable due to coexisting comorbidities or that refuse surgery. SBRT regimens used will be 4 fractions of 12 Gy or 3 fractions of 17 Gy depending on tumor location in a risk-adapted approach.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 90 Years
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

1. Stage T1,T2,T3N0M0 NSCLC, histological confirmation either by biopsy or cytology

2. Maximal tumor diameter of 6 cm

3. Only T3 lesions based upon thoracic wall involvement, only 1 lesion

4. Informed consent is required

5. Life expectancy of at least 6 months

6. Age >/= 18 y.

7. Karnofsky score ≥ 70 or ECOG score ≤ 2

8. Inoperable patients or patients refusing surgery

9. Patients with measurable lesion (according to RECIST criteria)

Exclusion Criteria:

1. Diagnosis of small cell lung cancer

2. Lymph node involvement

3. Prior radiotherapy to the chest and/or mediastinum

4. No chemotherapy and/or targeted treatment within 3 months before SBRT

5. Pregnant or lactating women

6. Known allergy for CT contrast

7. No FDG-PET

8. Mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the study.

9. 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.
Location
UZ Brussel Radiotherapie dienst
Jette, Brussels, Belgium
Status: Recruiting
Contact: Christine Collen, MD - +3224763438 - christine.collen@uzbrussel.be
Start Date
January 2013
Sponsors
Universitair Ziekenhuis Brussel
Source
Universitair Ziekenhuis Brussel
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page