Non Small Cell Lung Cancer Clinical Trial
Official title:
SBRT Radiotherapy for Non-operated Non-small-cell Lung Cancer (NSCLC), T1-T2, N0, M0
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.
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).
;
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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