Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
Centre Leon Berard Ministry of Health, France |
---|---|
Information provided by: | Centre Leon Berard |
ClinicalTrials.gov Identifier: | NCT00349102 |
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.
Condition | Intervention | Phase |
---|---|---|
Carcinoma, Non-Small-Cell Lung |
Radiation: Free breathing Radiation: Breath holding |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Evaluation of the Interest of Breath Holding for the Prevention of Radiation Pneumonitis Following Conformal Radiation Therapy |
Estimated Enrollment: | 240 |
Study Start Date: | July 2006 |
Estimated Study Completion Date: | July 2013 |
Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A: Active Comparator
Free breathing during conformal radiation
|
Radiation: Free breathing
Free breathing during conformal radiation
|
B: Experimental
Breath holding during conformal radiation
|
Radiation: Breath holding
Breath holding during conformal radiation
|
The secondary objectives are:
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Sophie DUSSART, MD | +33 478 78 27 52 | dussart@lyon.fnclcc.fr |
Contact: Severine GUILLEMAUT | +33 478 78 29 68 | denizot@lyon.fnclcc.fr |
France | |
Centre Léon Bérard | Recruiting |
LYON, France, 69008 | |
Contact: Line CLAUDE, MD +33 478 78 26 49 claude@lyon.fnclcc.fr | |
Contact: Séverine GUILLEMAUT +33 478 78 29 68 denizot@lyon.fnclcc.fr | |
Sub-Investigator: Christian CARRIE, MD | |
Sub-Investigator: Isabelle MARTEL-LAFAY, MD | |
Principal Investigator: Line CLAUDE, MD | |
Sub-Investigator: Anne CHILLES, MD | |
Sub-Investigator: Victor PASSERAT, MD | |
Institut Curie | Recruiting |
PARIS, France, 75005 | |
Contact: Sylvie HELFRE, MD + 33 144 32 46 26 sylvie.helfre@curie.net | |
Principal Investigator: Sylvie HELFRE, MD | |
Hôpital Européen Georges Pompidou | Recruiting |
PARIS, France, 75015 | |
Contact: Catherine DURDUX, MD +33 156 09 34 05 catherine.durdux@egp.aphp.fr | |
Principal Investigator: Catherine DURDUX, MD | |
Centre Catalan d'Oncologie | Recruiting |
PERPIGNAN, France, 66000 | |
Contact: Daniel CASTERA, MD daniel.castera@aliceadsl.fr | |
Principal Investigator: Daniel CASTERA, MD | |
Centre René Gauducheau | Recruiting |
SAINT HERBLAIN, France, 44805 | |
Contact: Marc MAHE, MD +33 240 67 99 00 ma-mahe@nantes.fnclcc.fr | |
Principal Investigator: Marc MAHE, MD | |
Sub-Investigator: Etienne BARDET, MD | |
Sub-Investigator: François THILLAYS, MD | |
Centre Oscar Lambret | Recruiting |
LILLE, France, 59020 | |
Contact: Bernard PREVOST, MD +33 320 29 55 53 b-prevost@o-lambret.fr | |
Principal Investigator: Bernard PREVOST, MD | |
Hôpital de la Pitié Salpêtrière | Active, not recruiting |
PARIS, France, 75013 |
Principal Investigator: | Line CLAUDE, MD | Centre Leon Berard, Lyon |
Responsible Party: | Centre Léon Bérard, 28 rue Laënnec, 69373 LYON Cedex 08, FRANCE ( Zora ABDELBOST ) |
Study ID Numbers: | GATING 2006, ET2005-052 |
Study First Received: | July 5, 2006 |
Last Updated: | November 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00349102 |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
Non-small-cell lung cancer Breath-hold Radiation pneumonitis |
Serum cytokines LENT-SOMA scale Non-metastatic non-small-cell lung cancer |
Thoracic Neoplasms Non-small cell lung cancer Lung Diseases, Interstitial Wounds and Injuries Disorders of Environmental Origin Carcinoma Respiratory Tract Diseases Respiratory Tract Infections |
Lung Neoplasms Lung Diseases Radiation Pneumonitis Carcinoma, Non-Small-Cell Lung Pneumonia Radiation Injuries Neoplasms, Glandular and Epithelial |
Respiratory Tract Neoplasms Neoplasms Neoplasms by Site Neoplasms by Histologic Type |