Overview

This trial is active, not recruiting.

Condition carcinoma, non-small-cell lung
Treatments free breathing, breath holding
Phase phase 3
Sponsor Centre Leon Berard
Collaborator Ministry of Health, France
Start date July 2006
End date January 2012
Trial size 240 participants
Trial identifier NCT00349102, ET2005-052, GATING 2006

Summary

The purpose of this study is to evaluate the interest of breath holding for the prevention of radiation pneumonitis following conformal radiation therapy.

Eligible patients will be randomly assigned in a 2-arm trial to free breathing or breath holding during conformal radiation.

The primary objective of the study is to establish the efficacy of breath holding, compared to free breathing, in the prevention of early pulmonary toxicity following conformal radiation.

Several departments of radiotherapy, many pneumology units and two basic and applied research laboratories take part in this multicentric study.

The number of patients required to demonstrate a reduction in radiation pneumonitis from 45 % to 22.5 %, assuming an alpha risk of 5% in a two-sided test and 95% power, is 240 (120 per arm). With a planned accrual of 7 patients per month, it is estimated that the inclusion period should be approximately 3 years.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Free breathing during conformal radiation
free breathing Free breathing
Free breathing during conformal radiation
(Experimental)
Breath holding during conformal radiation
breath holding Breath holding
Breath holding during conformal radiation

Primary Outcomes

Measure
Clinical, functional and radiological evaluations at 6-8 weeks and 10-12 weeks after the end of irradiation
time frame: 6-8 and 10-12 weeks after the end of irradiation

Secondary Outcomes

Measure
RTOG and LENT-SOMA scores at 6-8 weeks and 10-12 weeks after the end of irradiation, response rates at 6-8 weeks, 1 year and 2 years after irradiation
time frame: 6-8 and 10-12 weeks after the end of irradiation

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Non-metastatic cytologically or histologically proven non-small-cell lung cancer (NSCLC) - Operated NSCLC patients requiring post-surgical irradiation or non-operated NSCLC patients requiring curative irradiation - Conformational thoracic radiotherapy with curative intent - Age >= 18 - Complete functional respiratory evaluation (FRE) performed less than 2 months before inclusion, demonstrating a maximum expiratory flow-volume/second > 1 l (in case surgery, the FRE must have been realized in the post-surgery period) - Thoracic CT-scan performed less than 2 months before inclusion for non-operated patient - PET-scan performed less than 2 months before inclusion for non-operated patient - Performance status (PS) ECOG <= 1 - Possible training on breath holding technique - Female patients of childbearing potential: effective method of contraception necessary - Mandatory affiliation with a social security system - Written, signed, informed consent Exclusion Criteria: - Small-cell lung cancer - Metastatic disease - Infiltrating pulmonary disease - Previous thoracic irradiation - Indication of irradiation with palliative intent - 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 - Patient understanding incompatible with the breath-hold technique (patients with major presbycusis are not eligible) - Pregnant or lactating woman - Patient included in another clinical trial - Follow-up difficult - Patient deprived of freedom

Additional Information

Official title Evaluation of the Interest of Breath Holding for the Prevention of Radiation Pneumonitis Following Conformal Radiation Therapy
Principal investigator Line CLAUDE, MD
Description The secondary objectives are: - Validation of the Lent-Soma toxicity scale by comparison to the RTOG scale, - Response rate at different times: week 6-8, 1 year and 2 years after the end of irradiation, - Progression-free survival rate at 1 year and 2 years after the end of irradiation - Confirmation of the predictive value of serum cytokine levels (IL-6 and IL-10) during irradiation for the occurrence of early radiation toxicity, and analysis of the correlation between these serum levels at inclusion and the expression polymorphism of candidate genes.
Trial information was received from ClinicalTrials.gov and was last updated in March 2013.
Information provided to ClinicalTrials.gov by Centre Leon Berard.