Non Small Cell Lung Cancer
Conditions
Keywords
SBRT, non-operated, non-metastatic, non-small-cell lung cancer, conformational radiotherapy, non-operated non-metastatic non-small-cell lung cancer
Brief summary
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
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).
Interventions
RADIATIONSBRT by cyberknife
treatment = 2x15 Gy during 2 weeks
RADIATIONSBRT by linear accelerator
treatment = 2x15 Gy during 2 weeks
RADIATIONConformational radiotherapy
treatment = 5x2 Gy during 7 weeks (free breathing or breath holding)
Sponsors
The Biostatistics and Therapy Evaluation Unit
National Cancer Institute, France
Centre Leon Berard
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of local control in patients with non-operated, non-metastatic non-small-cell lung cancer treated by radiotherapy | 2 years |
Secondary
| Measure | 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 |
Countries
France
Outcome results
None listed