Prevention of Radiation Pneumonitis After Three-dimensional Conformal Radiation Therapy (3D-CRT) in Patients With Non-small-cell Lung Cancer - Full Text View

Sponsor:	Centre Leon Berard
Collaborator:	Ministry of Health, France
Information provided by:	Centre Leon Berard
ClinicalTrials.gov Identifier:	NCT00349102

Purpose

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:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Evaluation of the Interest of Breath Holding for the Prevention of Radiation Pneumonitis Following Conformal Radiation Therapy

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer Pneumonia

U.S. FDA Resources

Further study details as provided by Centre Leon Berard:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]

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
Active Comparator: A Free breathing during conformal radiation	Radiation: Free breathing Free breathing during conformal radiation Other Names: Free breathing Conformal radiation Lung cancer
Experimental: B Breath holding during conformal radiation	Radiation: Breath holding Breath holding during conformal radiation Other Names: Breath holding Conformal radiation Lung cancer

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00349102

Contacts

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

Locations

France
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
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
Hôpital de la Pitié Salpêtrière	Active, not recruiting
Paris, France, 75013
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

Sponsors and Collaborators

Centre Leon Berard

Ministry of Health, France

Investigators

Principal Investigator:

Line CLAUDE, MD

Centre Leon Berard, Lyon

More Information

Publications:

Arpin D, Perol D, Blay JY, Falchero L, Claude L, Vuillermoz-Blas S, Martel-Lafay I, Ginestet C, Alberti L, Nosov D, Etienne-Mastroianni B, Cottin V, Perol M, Guerin JC, Cordier JF, Carrie C. Early variations of circulating interleukin-6 and interleukin-10 levels during thoracic radiotherapy are predictive for radiation pneumonitis. J Clin Oncol. 2005 Dec 1;23(34):8748-56.

Claude L, Perol D, Ginestet C, Falchero L, Arpin D, Vincent M, Martel I, Hominal S, Cordier JF, Carrie C. A prospective study on radiation pneumonitis following conformal radiation therapy in non-small-cell lung cancer: clinical and dosimetric factors analysis. Radiother Oncol. 2004 May;71(2):175-81.

Responsible Party:	Zora ABDELBOST, Centre Léon Bérard, 28 rue Laënnec, 69373 LYON Cedex 08, FRANCE
ClinicalTrials.gov Identifier:	NCT00349102 History of Changes
Other Study ID Numbers:	GATING 2006, ET2005-052
Study First Received:	July 5, 2006
Last Updated:	July 12, 2011
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Centre Leon Berard:

Non-small-cell lung cancer
Breath-hold
Radiation pneumonitis

Serum cytokines
LENT-SOMA scale
Non-metastatic non-small-cell lung cancer

Additional relevant MeSH terms:

Carcinoma
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Pneumonia
Radiation Pneumonitis
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms

Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Lung Diseases, Interstitial
Lung Injury
Radiation Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on February 09, 2012