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

NCT ID: NCT00870116

Last Updated: 2013-03-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-30
• Study Completion Date: 2013-03-31

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).

Conditions

Non Small Cell Lung Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1 - SBRT using cyberknife

SBRT using cyberknife: treatment = 2x15 Gy during 2 weeks

Group Type: OTHER

SBRT by cyberknife

Intervention Type: RADIATION

treatment = 2x15 Gy during 2 weeks

2 - SBRT using linear accelerator

SBRT using linear accelerator: treatment = 2x15 Gy during 2 weeks

Group Type: OTHER

SBRT by linear accelerator

Intervention Type: RADIATION

treatment = 2x15 Gy during 2 weeks

3 - Conformational radiotherapy

Conformational radiotherapy: treatment = 5x2 Gy during 7 weeks

Group Type: OTHER

Conformational radiotherapy

Intervention Type: RADIATION

treatment = 5x2 Gy during 7 weeks (free breathing or breath holding)

Interventions

SBRT by cyberknife

treatment = 2x15 Gy during 2 weeks

Intervention Type: RADIATION

SBRT by linear accelerator

treatment = 2x15 Gy during 2 weeks

Intervention Type: RADIATION

Conformational radiotherapy

treatment = 5x2 Gy during 7 weeks (free breathing or breath holding)

Intervention Type: RADIATION

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Biostatistics and Therapy Evaluation Unit

OTHER

Sponsor Role: collaborator

National Cancer Institute, France

OTHER_GOV

Sponsor Role: collaborator

Centre Leon Berard

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Line CLAUDE, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Léon Bérard, Lyon

Locations

Centre Georges François Leclerc

Dijon, , France

Centre Oscar Lambret

Lille, , France

Centre Leon Berard

Lyon, , France

Centre Val d'Aurelle Paul Lamarque

Montpellier, , France

Centre Antoine Lacassagne

Nice, , France

Hôpital Tenon

Paris, , France

CHLS

Pierre-Bénite, , France

Centre René Gauducheau

Saint-Herblain, , France

Centre Alexis Vautrin

Vandœuvre-lès-Nancy, , France

Countries

France

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Other Identifiers

ET2008-067

Identifier Type: -

Identifier Source: secondary_id

SBRT CNPC

Identifier Type: -

Identifier Source: org_study_id