- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00349102
Prevention of Radiation Pneumonitis After Three-dimensional Conformal Radiation Therapy (3D-CRT) in Patients With Non-small-cell Lung Cancer
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
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Lille, France, 59020
- Centre Oscar Lambret
-
Lyon, France, 69008
- Centre léon Bérard
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Paris, France, 75015
- Hopital Europeen Georges Pompidou
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Paris, France, 75005
- Institut Curie
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Paris, France, 75013
- Hopital de la Pitie Salpetriere
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Perpignan, France, 66000
- Centre Catalan d'Oncologie
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Saint Herblain, France, 44805
- Centre Rene Gauducheau
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: A
Free breathing during conformal radiation
|
Free breathing during conformal radiation
Other Names:
|
Experimental: B
Breath holding during conformal radiation
|
Breath holding during conformal radiation
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
6-8 and 10-12 weeks after the end of irradiation
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
6-8 and 10-12 weeks after the end of irradiation
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Line CLAUDE, MD, Centre Léon Bérard, Lyon
Publications and helpful links
General 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. doi: 10.1200/JCO.2005.01.7145.
- 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. doi: 10.1016/j.radonc.2004.02.005.
- L. Falchero, D. Perol, D. Arpin, M. Vincent, M. Perol, JF. Cordier, D. Boutry, I. Martel-Lafay, C. Carrie.- Conséquences fonctionnelles de la radiothérapie thoracique conformationnelle (r3d) et facteurs prédictifs de pneumopathie radique aiguë (PRA) chez des patients atteints de cancer bronchique non à petites cellules (CNPC). Rev. Mal. Resp., 2001 ; 18 (suppl) : 1S102
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Wounds and Injuries
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Lung Diseases, Interstitial
- Lung Injury
- Radiation Injuries
- Carcinoma, Non-Small-Cell Lung
- Pneumonia
- Radiation Pneumonitis
Other Study ID Numbers
- GATING 2006
- ET2005-052
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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