Stereotactic Body Radio Therapy (SBRT) for Early-stage Non Small Cell Lung Cancer (NSCLC)
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|
|Dijon, France||Centre Georges François Leclerc||no longer recruiting|
|Lille, France||Centre Oscar Lambret||no longer recruiting|
|Lyon, France||Centre Leon Berard||no longer recruiting|
|Montpellier, France||Centre Val d'Aurelle Paul Lamarque||no longer recruiting|
|Nice, France||Centre Antoine Lacassagne||no longer recruiting|
|Paris, France||Hôpital Tenon||no longer recruiting|
|Pierre Bénite, France||CHLS||no longer recruiting|
|Saint Herblain, France||Centre René Gauducheau||no longer recruiting|
|Vandoeuvre les Nancy, France||Centre Alexis Vautrin||no longer recruiting|
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
Evaluation of local control in patients with non-operated, non-metastatic non-small-cell lung cancer treated by radiotherapy
time frame: 2 years
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
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
|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).|
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