Carcinoma, Non-small-cell Lung Clinical Trial
Official title:
Evaluation of the Interest of Breath Holding for the Prevention of Radiation Pneumonitis Following Conformal Radiation Therapy
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.
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.
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