Clinical Trial: Prevention of Radiation Pneumonitis After Three-dimensional Conformal Radiation Therapy (3D-CRT) in Patients With Non-small-cell Lung Cancer

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Evaluation of the Interest of Breath Holding for the Prevention of Radiation Pneumonitis Following Conformal Radiation Therapy

Brief 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.


Detailed Summary:

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.

Sponsor: Centre Leon Berard

Current Primary Outcome: 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 ]

Original Primary Outcome: Clinical, functional and radiological evaluations at 6-8 weeks and 10-12 weeks after the end of irradiation

Current Secondary Outcome: 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 ]

Original Secondary Outcome: 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

Information By: Centre Leon Berard

Dates:
Date Received: July 5, 2006
Date Started: July 2006
Date Completion:
Last Updated: January 31, 2017
Last Verified: January 2017