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

NCT00870116 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2013-03-06

No results posted yet for this study

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.

Conditions

  • Non Small Cell Lung Cancer

Interventions

RADIATION

SBRT by cyberknife

treatment = 2x15 Gy during 2 weeks

RADIATION

SBRT by linear accelerator

treatment = 2x15 Gy during 2 weeks

RADIATION

Conformational radiotherapy

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

Sponsors & Collaborators

  • The Biostatistics and Therapy Evaluation Unit

    collaborator OTHER

  • National Cancer Institute, France

    collaborator OTHER_GOV

  • Centre Leon Berard

    lead OTHER

Principal Investigators

  • Line CLAUDE, MD · Centre Léon Bérard, Lyon

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2013-03-31
Completion
2013-03-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00870116 on ClinicalTrials.gov