Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
No phase specified	Treatment	Active	18 and over	Other	SBRT CNPC ET2008-067, NCT00870116

Trial Description

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.

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).

Eligibility Criteria

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

Trial Contact Information

Trial Lead Organizations/Sponsors

Centre Leon Berard

Line CLAUDE, MD

Principal Investigator

DUSSART Sophie, MD		Ph: +33 4 78 78 27 52
		Email: dussart@lyon.fnclcc.fr

France
	Lyon
	Centre Leon Berard
		Line CLAUDE, MD	Ph: +33 4 78 78 26 49
			Email: claude@lyon.fnclcc.fr
		Line CLAUDE, MD	Principal Investigator
		Christian CARRIE, MD	Sub-Investigator
		Isabelle MARTEL-LAFAY, MD	Sub-Investigator
		Etienne MARTIN, MD	Sub-Investigator
		Victor PASSERAT, MD	Sub-Investigator
	Montpellier
	Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
		Jean Bernard DUBOIS, MD	Ph: 04 67 61 31 13
			Email: jbdubois@valdorel.fnclcc.fr
		Jean Bernard DUBOIS, MD	Principal Investigator
		Pierre BOISSELIER, MD	Sub-Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00870116
Information obtained from ClinicalTrials.gov on October 25, 2009

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