Stereotactic Body Radio Therapy (SBRT) for Early-stage Non Small Cell Lung Cancer (NSCLC) (SBRT-NSCLC)
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|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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|