Status:
UNKNOWN
Stereotactic Body Radio Therapy (SBRT) for Early-stage Non Small Cell Lung Cancer (NSCLC)
Lead Sponsor:
Centre Leon Berard
Collaborating Sponsors:
The Biostatistics and Therapy Evaluation Unit
National Cancer Institute, France
Conditions:
Non Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate local disease control after 2 years in patients with non-metastatic, non-operated non-small-cell lung cancer treated by radiotherapy. Eligible patients will b...
Detailed Description
The main objective of this study is to do a health economic evaluation of innovating techniques in radiotherapy. SBRT is the very precise delivery of high-powered radiation to small target volumes, u...
Eligibility Criteria
Inclusion
- Non-operated non-small-cell lung cancer (NSCLC) (inoperable tumor or patient refusal of surgery)
- cytologically or histologically proven NSCLC Or
- primitive pulmonary tumor of unproven malignancy
- macroscopically normal bronchial endoscopy, negative cytology and biopsies
- AND size increase on 2 successive scans (at 10-12 weeks interval)
- AND hypermetabolic PET-CT pattern
- AND absence of other proven etiology
- Tumor \< 5cm, distant (\> 1.5 cm) from large vessels, principally in the bronchus and spinal-cord
- No metastasis: M0
- No lymph node involvement: N0
- Functional respiratory evaluation (FRE) compatible with thoracic irradiation
- Maximum expiratory flow-volume \> 30% theoretical value
- Age \>= 18
- ECOG PS \<= 2
- Female patients of childbearing potential: effective method of contraception
- Written advice of the RCP (conciliation meeting) present in the patient file
- Mandatory affiliation with a social security system
- Written, signed informed consent
Exclusion
- Previously operated tumors
- Previous thoracic irradiation
- Previous or concurrent primary malignancies at other sites (except basocellular skin cancer or cervical cancer in situ or complete remission for more than 5 years)
- Life expectancy \< 6 months
- Pregnant or lactating woman
- Difficult follow-up
- Patient deprived of freedom
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2013
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00870116
Start Date
April 1 2009
End Date
March 1 2013
Last Update
March 6 2013
Active Locations (9)
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1
Centre Georges François Leclerc
Dijon, France, 21000
2
Centre Oscar Lambret
Lille, France, 59000
3
Centre Leon Berard
Lyon, France, 69008
4
Centre Val d'Aurelle Paul Lamarque
Montpellier, France, 34000