Clinical trial NCT00870116: Stereotactic Body Radio Therapy (SBRT) for Early-stage Non Small Cell Lung Cancer (NSCLC)
Official title: SBRT Radiotherapy for Non-operated Non-small-cell Lung Cancer (NSCLC), T1-T2, N0, M0
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Non Small Cell Lung Cancer
Keywords: SBRT
non-operated
non-metastatic
non-small-cell lung cancer
conformational radiotherapy
non-operated non-metastatic non-small-cell lung cancer
Lead sponsor: Centre Leon Berard
Sponsor class: OTHER
Collaborators: name: The Biostatistics and Therapy Evaluation Unit
name: National Cancer Institute, France
First posted: 2009-03-26
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

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, 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

Primary outcomes:
measure: Evaluation of local control in patients with non-operated, non-metastatic non-small-cell lung cancer treated by radiotherapy
timeFrame: 2 years
Secondary outcomes:
measure: Health economic evaluation of the various methods used for stereotactic radiotherapy
timeFrame: during treatment / post treatment
measure: Prospective evaluation of acute and late toxicities of SBRT
timeFrame: M1, M3, M6, M12, M18 and M24
measure: Study of quality of life in the 3 groups
timeFrame: inclusion, M1, M3, M12
measure: Evaluation of progression-free survival and overall survival in the 3 groups
timeFrame: No time
Other outcomes:
Locations:
city: Dijon
country: France
facility: Centre Georges François Leclerc
city: Lille
country: France
facility: Centre Oscar Lambret
city: Lyon
country: France
facility: Centre Leon Berard
city: Montpellier
country: France
facility: Centre Val d'Aurelle Paul Lamarque
city: Nice
country: France
facility: Centre Antoine Lacassagne
city: Paris
country: France
facility: Hôpital Tenon
city: Pierre Bénite
country: France
facility: CHLS
city: Saint Herblain
country: France
facility: Centre René Gauducheau
city: Vandoeuvre les Nancy
country: France
facility: Centre Alexis Vautrin
Study officials:
affiliation: Centre Léon Bérard, LYON
name: Line CLAUDE, MD
role: PRINCIPAL_INVESTIGATOR
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