Stereotactic Body Radio Therapy (SBRT) for Early-stage Non Small Cell Lung Cancer (NSCLC)

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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SBRT Radiotherapy for Non-operated Non-small-cell Lung Cancer (NSCLC), T1-T2, N0, M0

Conditions
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Non Small Cell Lung Cancer

Intervention / Treatment
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* Radiation: SBRT by cyberknife
* Radiation: SBRT by linear accelerator
* Radiation: Conformational radiotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1 - SBRT using cyberknife<br>SBRT using cyberknife: treatment = 2x15 Gy during 2 weeks | Radiation: SBRT by cyberknife<br>* treatment = 2x15 Gy during 2 weeks<br>|
| Other: 2 - SBRT using linear accelerator<br>SBRT using linear accelerator: treatment = 2x15 Gy during 2 weeks | Radiation: SBRT by linear accelerator<br>* treatment = 2x15 Gy during 2 weeks<br>|
| Other: 3 - Conformational radiotherapy<br>Conformational radiotherapy: treatment = 5x2 Gy during 7 weeks | Radiation: Conformational radiotherapy<br>* treatment = 5x2 Gy during 7 weeks (free breathing or breath holding)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of local control in patients with non-operated, non-metastatic non-small-cell lung cancer treated by radiotherapy |  | 2 years | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SBRT, non-operated, non-metastatic, non-small-cell lung cancer, conformational radiotherapy, non-operated non-metastatic non-small-cell lung cancer