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

March 5, 2013 updated by: Centre Leon Berard

SBRT Radiotherapy for Non-operated Non-small-cell Lung Cancer (NSCLC), T1-T2, N0, M0

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.

Study Overview

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 Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Dijon, France, 21000
        • Centre Georges François Leclerc
      • Lille, France, 59000
        • Centre Oscar Lambret
      • Lyon, France, 69008
        • Centre Léon Berard
      • Montpellier, France, 34000
        • Centre Val d'Aurelle Paul Lamarque
      • Nice, France, 06000
        • Centre Antoine LACASSAGNE
      • Paris, France, 75012
        • Hôpital Tenon
      • Pierre Bénite, France, 69495
        • CHLS
      • Saint Herblain, France, 44000
        • Centre Rene Gauducheau
      • Vandoeuvre les Nancy, France, 54511
        • Centre Alexis Vautrin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 1 - SBRT using cyberknife
SBRT using cyberknife: treatment = 2x15 Gy during 2 weeks
treatment = 2x15 Gy during 2 weeks
Other: 2 - SBRT using linear accelerator
SBRT using linear accelerator: treatment = 2x15 Gy during 2 weeks
treatment = 2x15 Gy during 2 weeks
Other: 3 - Conformational radiotherapy
Conformational radiotherapy: treatment = 5x2 Gy during 7 weeks
treatment = 5x2 Gy during 7 weeks (free breathing or breath holding)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluation of local control in patients with non-operated, non-metastatic non-small-cell lung cancer treated by radiotherapy
Time Frame: 2 years
2 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Line CLAUDE, MD, Centre Léon Bérard, Lyon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Anticipated)

March 1, 2013

Study Completion (Anticipated)

March 1, 2013

Study Registration Dates

First Submitted

March 25, 2009

First Submitted That Met QC Criteria

March 25, 2009

First Posted (Estimate)

March 26, 2009

Study Record Updates

Last Update Posted (Estimate)

March 6, 2013

Last Update Submitted That Met QC Criteria

March 5, 2013

Last Verified

February 1, 2013

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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