This trial is active, not recruiting.

Condition non small cell lung cancer
Treatments sbrt by cyberknife, sbrt by linear accelerator, conformational radiotherapy
Sponsor Centre Leon Berard
Collaborator UBET (Unité de Biostatistiques et d'Evaluation des Thérapeutiques - C. L. Bérard)
Start date April 2009
End date March 2013
Trial size 120 participants
Trial identifier NCT00870116, ET2008-067, SBRT CNPC


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
SBRT using cyberknife: treatment = 2x15 Gy during 2 weeks
sbrt by cyberknife
treatment = 2x15 Gy during 2 weeks
SBRT using linear accelerator: treatment = 2x15 Gy during 2 weeks
sbrt by linear accelerator
treatment = 2x15 Gy during 2 weeks
Conformational radiotherapy: treatment = 5x2 Gy during 7 weeks
conformational radiotherapy
treatment = 5x2 Gy during 7 weeks (free breathing or breath holding)

Primary Outcomes

Evaluation of local control in patients with non-operated, non-metastatic non-small-cell lung cancer treated by radiotherapy
time frame: 2 years

Secondary Outcomes

Health economic evaluation of the various methods used for stereotactic radiotherapy
time frame: during treatment / post treatment
Prospective evaluation of acute and late toxicities of SBRT
time frame: M1, M3, M6, M12, M18 and M24
Study of quality of life in the 3 groups
time frame: inclusion, M1, M3, M12
Evaluation of progression-free survival and overall survival in the 3 groups
time frame: No time

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title SBRT Radiotherapy for Non-operated Non-small-cell Lung Cancer (NSCLC), T1-T2, N0, M0
Principal investigator Line CLAUDE, MD
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).
Trial information was received from ClinicalTrials.gov and was last updated in March 2013.
Information provided to ClinicalTrials.gov by Centre Leon Berard.