SBRT Radiotherapy for Non-operated Non-small-cell Lung Cancer (NSCLC), T1-T2, N0, M0
18 Years
N/A
Both
Non Small Cell Lung Cancer
Trial Information
SBRT Radiotherapy for Non-operated Non-small-cell Lung Cancer (NSCLC), T1-T2, N0, M0
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, using
multiple low-intensity beams. Extremely precise patient positioning and target location is
essential for accurate treatment delivery.
Several studies have shown a benefit of SBRT in terms of local control and progression-free
survival, in particular for the treatment of cerebral metastases of limited number and size.
The development of this technique is recent. The number of treatment sessions is low: 1 to
4.
But the patient is exposed to a major risk of toxicity in several organs: the bronchi, the
lungs, large vessels, the oesophagus and the spinal-cord.
Pulmonary SBRT imposes strict rules and the use of specific equipment.
Extra-cranial SBRT can be realized using either:
- Conventional linear-accelerator equipped SBRT,
- Cyberknife SBRT.
3 groups of treatment will be evaluated in this study:
- SBRT by cyberknife,
- SBRT by linear accelerator,
- Conformational radiotherapy (free breathing or breath holding).
Inclusion Criteria:
- 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 Criteria:
- 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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Evaluation of local control in patients with non-operated, non-metastatic non-small-cell lung cancer treated by radiotherapy
Outcome Time Frame:
2 years
Safety Issue:
No
Principal Investigator
Line CLAUDE, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Centre Léon Bérard, LYON
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
SBRT CNPC
NCT ID:
NCT00870116
Start Date:
April 2009
Completion Date:
March 2013
Related Keywords:
- Non Small Cell Lung Cancer
- SBRT
- non-operated
- non-metastatic
- non-small-cell lung cancer
- conformational radiotherapy
- non-operated non-metastatic non-small-cell lung cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
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