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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
UBET (Unité de Biostatistiques et d'Evaluation des Thérapeutiques - C. L. Bérard)
National Cancer Institute, France
Information provided by (Responsible Party):
Centre Leon Berard
ClinicalTrials.gov Identifier:
NCT00870116
First received: March 25, 2009
Last updated: March 5, 2013
Last verified: February 2013
  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: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: SBRT Radiotherapy for Non-operated Non-small-cell Lung Cancer (NSCLC), T1-T2, N0, M0

Resource links provided by NLM:


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
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, see Learn About Clinical Studies.

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

Locations
France
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
CHLS
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
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:
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.
Kaplan EL., MP. Nonparametric estimation from incomplete observations. 1958. J Am Stat Assoc 1958; 53:457-481

Responsible Party: Centre Leon Berard
ClinicalTrials.gov Identifier: NCT00870116     History of Changes
Other Study ID Numbers: SBRT CNPC, ET2008-067
Study First Received: March 25, 2009
Last Updated: March 5, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on October 22, 2014