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SBRT Radiotherapy for Non-operated Non-small-cell Lung Cancer (NSCLC), T1-T2, N0, M0

18 Years
Open (Enrolling)
Non Small Cell Lung Cancer

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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

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

- 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:


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:


Principal Investigator


Investigator Role:

Principal Investigator

Investigator Affiliation:

Centre Léon Bérard, LYON


France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:




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