Stereotactic Body Radio Therapy (SBRT) for Early-stage Non Small Cell Lung Cancer (NSCLC) (SBRT-NSCLC)
|ClinicalTrials.gov Identifier: NCT00870116|
Recruitment Status : Unknown
Verified February 2013 by Centre Leon Berard.
Recruitment status was: Active, not recruiting
First Posted : March 26, 2009
Last Update Posted : March 6, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Non Small Cell Lung Cancer||Radiation: SBRT by cyberknife Radiation: SBRT by linear accelerator Radiation: Conformational radiotherapy||Not Applicable|
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,
3 groups of treatment will be evaluated in this study:
- SBRT by cyberknife,
- SBRT by linear accelerator,
- Conformational radiotherapy (free breathing or breath holding).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||SBRT Radiotherapy for Non-operated Non-small-cell Lung Cancer (NSCLC), T1-T2, N0, M0|
|Study Start Date :||April 2009|
|Estimated Primary Completion Date :||March 2013|
|Estimated Study Completion Date :||March 2013|
1 - SBRT using cyberknife
SBRT using cyberknife: treatment = 2x15 Gy during 2 weeks
Radiation: SBRT by cyberknife
treatment = 2x15 Gy during 2 weeks
2 - SBRT using linear accelerator
SBRT using linear accelerator: treatment = 2x15 Gy during 2 weeks
Radiation: SBRT by linear accelerator
treatment = 2x15 Gy during 2 weeks
3 - Conformational radiotherapy
Conformational radiotherapy: treatment = 5x2 Gy during 7 weeks
Radiation: Conformational radiotherapy
treatment = 5x2 Gy during 7 weeks (free breathing or breath holding)
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00870116
|Centre Georges François Leclerc|
|Dijon, France, 21000|
|Centre Oscar Lambret|
|Lille, France, 59000|
|Centre Leon Berard|
|Lyon, France, 69008|
|Centre Val d'Aurelle Paul Lamarque|
|Montpellier, France, 34000|
|Centre Antoine Lacassagne|
|Nice, France, 06000|
|Paris, France, 75012|
|Pierre Bénite, France, 69495|
|Centre René Gauducheau|
|Saint Herblain, France, 44000|
|Centre Alexis Vautrin|
|Vandoeuvre les Nancy, France, 54511|
|Principal Investigator:||Line CLAUDE, MD||Centre Léon Bérard, LYON|