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

Not Applicable

• Conditions: Non Small Cell Lung Cancer
• Interventions: Radiation: SBRT by cyberknife; Radiation: SBRT by linear accelerator; Radiation: Conformational radiotherapy

• Registration Number: NCT00870116
• Lead Sponsor: Centre Leon Berard

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).

Study Timeline

• Study First Submitted: 2009-03-25
• Study First Submitted QC: 2009-03-25
• Study First Posted: 2009-03-26
• Study Start: 2009-04
• Status Verified: 2013-02
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Last Update Submitted: 2013-03-05
• Last Update Posted: 2013-03-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1 - SBRT using cyberknife	SBRT by cyberknife	SBRT using cyberknife: treatment = 2x15 Gy during 2 weeks
2 - SBRT using linear accelerator	SBRT by linear accelerator	SBRT using linear accelerator: treatment = 2x15 Gy during 2 weeks
3 - Conformational radiotherapy	Conformational radiotherapy	Conformational radiotherapy: treatment = 5x2 Gy during 7 weeks

Primary Outcome Measures

Name	Time	Method
Evaluation of local control in patients with non-operated, non-metastatic non-small-cell lung cancer treated by radiotherapy	2 years

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (9)

Centre Alexis Vautrin; 🇫🇷 Vandoeuvre les Nancy, France

Hôpital Tenon; 🇫🇷 Paris, France

CHLS; 🇫🇷 Pierre Bénite, France

Centre René Gauducheau; 🇫🇷 Saint Herblain, France

Centre Val d'Aurelle Paul Lamarque; 🇫🇷 Montpellier, France

Centre Leon Berard; 🇫🇷 Lyon, France

Centre Oscar Lambret; 🇫🇷 Lille, France

Centre Georges François Leclerc; 🇫🇷 Dijon, France

Centre Antoine Lacassagne; 🇫🇷 Nice, France