Ignite Creation Date:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2025-12-26 @ 2:35 AM
Study NCT ID:
NCT00349102
Status:
COMPLETED
Last Update Posted:
2017-02-01
First Post:
2006-07-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prevention of Radiation Pneumonitis After Three-dimensional Conformal Radiation Therapy (3D-CRT) in Patients With Non-small-cell Lung Cancer
Sponsor:
Centre Leon Berard
Organization:
Study Overview
Official Title:
Evaluation of the Interest of Breath Holding for the Prevention of Radiation Pneumonitis Following Conformal Radiation Therapy
Status:
COMPLETED
Status Verified Date:
2017-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 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.
* 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| ET2005-052 | None | None | View |