|No phase specified||Treatment||Closed||18 and over||Other||SBRT CNPC|
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.
Further Study Information
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).
- 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
- 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
Trial Lead Organizations/Sponsors
Centre Leon BerardCentre Leon Berard
Institut National du Cancer
|Line CLAUDE, MD||Principal Investigator|
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00870116
ClinicalTrials.gov processed this data on October 17, 2013
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