Stereotactic Body Radio Therapy (SBRT) for Early-Stage Non Small Cell Lung Cancer (NSCLC) - Full Text View

Sponsor:	Centre Leon Berard
Collaborators:	UBET (Unité de Biostatistiques et d'Evaluation des Thérapeutiques - C. L. Bérard) National Cancer Institute, France
Information provided by:	Centre Leon Berard
ClinicalTrials.gov Identifier:	NCT00870116

Purpose

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.

Condition	Intervention
Non Small Cell Lung Cancer	Radiation: SBRT by cyberknife Radiation: SBRT by linear accelerator Radiation: Conformational radiotherapy

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study
Official Title:	SBRT Radiotherapy for Non-Operated Non-Small-Cell Lung Cancer (NSCLC), T1-T2, N0, M0

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

U.S. FDA Resources

Further study details as provided by Centre Leon Berard:

Primary Outcome Measures:

Evaluation of local control in patients with non-operated, non-metastatic non-small-cell lung cancer treated by radiotherapy [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Health economic evaluation of the various methods used for stereotactic radiotherapy [ Time Frame: during treatment / post treatment ] [ Designated as safety issue: No ]
Prospective evaluation of acute and late toxicities of SBRT [ Time Frame: M1, M3, M6, M12, M18 and M24 ] [ Designated as safety issue: No ]
Study of quality of life in the 3 groups [ Time Frame: inclusion, M1, M3, M12 ] [ Designated as safety issue: No ]
Evaluation of progression-free survival and overall survival in the 3 groups [ Time Frame: No time ] [ Designated as safety issue: No ]

Estimated Enrollment:	120
Study Start Date:	April 2009
Estimated Study Completion Date:	March 2013
Estimated Primary Completion Date:	March 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 - SBRT using cyberknife SBRT using cyberknife: treatment = 2x15 Gy during 2 weeks	Radiation: SBRT by cyberknife treatment = 2x15 Gy during 2 weeks
2 - SBRT using linear accelerator SBRT using linear accelerator: treatment = 2x15 Gy during 2 weeks	Radiation: SBRT by linear accelerator treatment = 2x15 Gy during 2 weeks
3 - Conformational radiotherapy Conformational radiotherapy: treatment = 5x2 Gy during 7 weeks	Radiation: Conformational radiotherapy treatment = 5x2 Gy during 7 weeks (free breathing or breath holding)

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).

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00870116

Contacts

Contact: DUSSART Sophie, MD

+33 4 78 78 27 52

dussart@lyon.fnclcc.fr

Locations

France
Centre Leon Berard	Recruiting
Lyon, France, 69008
Contact: Line CLAUDE, MD +33 4 78 78 26 49 claude@lyon.fnclcc.fr
Principal Investigator: Line CLAUDE, MD
Sub-Investigator: Christian CARRIE, MD
Sub-Investigator: Isabelle MARTEL-LAFAY, MD
Sub-Investigator: Etienne MARTIN, MD
Sub-Investigator: Victor PASSERAT, MD
Centre Georges François Leclerc	Active, not recruiting
Dijon, France, 21000
Centre Oscar Lambret	Not yet recruiting
Lille, France, 59000
Contact: Eric LARTIGAU, MD 03 20 29 59 35 e-lartigau@o-lambret.fr
Principal Investigator: Eric LARTIGAU, MD
Sub-Investigator: Bernard PREVOST, MD
Centre Val d'Aurelle Paul Lamarque	Recruiting
Montpellier, France, 34000
Contact: Jean Bernard DUBOIS, MD 04 67 61 31 13 jbdubois@valdorel.fnclcc.fr
Principal Investigator: Jean Bernard DUBOIS, MD
Sub-Investigator: Pierre BOISSELIER, MD
Centre Alexis Vautrin	Not yet recruiting
Vandoeuvre les Nancy, France, 54511
Contact: Véronique BECKENDORF, MD 03 83 59 84 27 v.beckendorf@nancy.fnclcc.fr
Principal Investigator: Véronique BECKENDORF, MD
Sub-Investigator: Didier PEIFFERT, MD
Centre Antoine Lacassagne	Active, not recruiting
Nice, France, 06000
Hôpital Tenon	Not yet recruiting
Paris, France, 75012
Contact: Emmanuel TOUBOUL, MD 01 56 01 62 10 emmanuel.touboul@tnn.aphp.fr
Principal Investigator: Emmanuel TOUBOUL, MD
CHLS	Active, not recruiting
Pierre Bénite, France, 69495
Centre René Gauducheau	Active, not recruiting
Saint Herblain, France, 44000

Sponsors and Collaborators

Centre Leon Berard

UBET (Unité de Biostatistiques et d'Evaluation des Thérapeutiques - C. L. Bérard)

National Cancer Institute, France

Investigators

Principal Investigator:

Line CLAUDE, MD

Centre Léon Bérard, LYON

More Information

Publications:

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Noel G, Bollet MA, Noel S, Feuvret L, Boisserie G, Tep B, Delattre JY, Baillet F, Ambroise Valery C, Cornu P, Mazeron JJ. Linac stereotactic radiosurgery: an effective and safe treatment for elderly patients with brain metastases. Int J Radiat Oncol Biol Phys. 2005 Dec 1;63(5):1555-61. Epub 2005 Jul 18.

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Responsible Party:	Centre Léon Bérard, 28 rue Laënnec, 69373 LYON Cedex 08, FRANCE ( Zora ABDELBOST )
Study ID Numbers:	SBRT CNPC, ET2008-067
Study First Received:	March 25, 2009
Last Updated:	June 15, 2009
ClinicalTrials.gov Identifier:	NCT00870116 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Centre Leon Berard:

SBRT
non-operated
non-metastatic

non-small-cell lung cancer
conformational radiotherapy
non-operated, non-metastatic non-small-cell lung cancer

Additional relevant MeSH terms:

Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Respiratory Tract Diseases

Lung Neoplasms
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

ClinicalTrials.gov processed this record on February 08, 2010