Stereotactic Body Radio Therapy (SBRT) for Early-stage Non Small Cell Lung Cancer (NSCLC)

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 be recruited and registered consecutively (no randomization). The estimated inclusion period is approximately 24 months. The duration of the research is 4 years.

The number of patients required in this multicentric prospective study is 120:

* 20 patients in the SBRT-1 arm (cyberknife),
* 80 patients in the SBRT-2 arm (linear accelerator-based)
* 20 patients in the conformational radiotherapy arm.

This is a prospective, multicentric, non comparative and non randomized study.

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).

Eligibility Criteria:
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