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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00870116
Recruitment Status : Unknown
Verified February 2013 by Centre Leon Berard.
Recruitment status was:  Active, not recruiting
First Posted : March 26, 2009
Last Update Posted : March 6, 2013
The Biostatistics and Therapy Evaluation Unit
National Cancer Institute, France
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Non Small Cell Lung Cancer Radiation: SBRT by cyberknife Radiation: SBRT by linear accelerator Radiation: Conformational radiotherapy Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: SBRT Radiotherapy for Non-operated Non-small-cell Lung Cancer (NSCLC), T1-T2, N0, M0
Study Start Date : April 2009
Estimated Primary Completion Date : March 2013
Estimated Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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)

Primary Outcome Measures :
  1. Evaluation of local control in patients with non-operated, non-metastatic non-small-cell lung cancer treated by radiotherapy [ Time Frame: 2 years ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00870116

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Centre Georges François Leclerc
Dijon, France, 21000
Centre Oscar Lambret
Lille, France, 59000
Centre Leon Berard
Lyon, France, 69008
Centre Val d'Aurelle Paul Lamarque
Montpellier, France, 34000
Centre Antoine Lacassagne
Nice, France, 06000
Hôpital Tenon
Paris, France, 75012
Pierre Bénite, France, 69495
Centre René Gauducheau
Saint Herblain, France, 44000
Centre Alexis Vautrin
Vandoeuvre les Nancy, France, 54511
Sponsors and Collaborators
Centre Leon Berard
The Biostatistics and Therapy Evaluation Unit
National Cancer Institute, France
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Principal Investigator: Line CLAUDE, MD Centre Léon Bérard, LYON
Publications of Results:
Evaluation de la radiothérapie fractionnée en condition stéréotaxiques des métastases cérébrales, STIC 2005
Tschung Sibley G. Radiotherapy for patient with medically inoperable stage I non-small cell lung cancer smaller doses and higher doses - a review. Cancer 2003;41:1-11
Timmerman R, Lohr F. Normal tissue Dose Constraints applied in lung stereotactic body radiation therapy. In Stereotactic Body Radiation Therapy, Pages 29-37; B.D. Kavanagh, R.D. Timmerman. Edts Lippicott Williams WilkinsSchemper M, Smith TL. A note on quantifying follow-up in studies of failure time. Control Clin Trials 1996; 17(4):343-346.

Other Publications:
Kaplan EL., MP. Nonparametric estimation from incomplete observations. 1958. J Am Stat Assoc 1958; 53:457-481
Pommier P. Modélisation spatiale et médico-économique des thérapeutiques innovantes : à propos du projet français ETOILE d'hadronthérapie par ions carbone. Thèse de Science en économie de la santé ; juin 2005
Pommier P, Ndiaga Gueye N, Buron C, Meyroneinc S. Modélisation du coût de l'innovation thérapeutique pour l'aide à la décision. Application à la radiothérapie par ions carbone (projet ETOILE). Santé et systémique 2007 ; 10 : 217-31

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Responsible Party: Centre Leon Berard Identifier: NCT00870116    
Other Study ID Numbers: SBRT CNPC
First Posted: March 26, 2009    Key Record Dates
Last Update Posted: March 6, 2013
Last Verified: February 2013
Keywords provided by Centre Leon Berard:
non-small-cell lung cancer
conformational radiotherapy
non-operated non-metastatic non-small-cell lung cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms