Status:
COMPLETED
Prevention of Radiation Pneumonitis After Three-dimensional Conformal Radiation Therapy (3D-CRT) in Patients With Non-small-cell Lung Cancer
Lead Sponsor:
Centre Leon Berard
Collaborating Sponsors:
Ministry of Health, France
Conditions:
Carcinoma, Non-small-cell Lung
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 ...
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 irradiati...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
242 Patients enrolled
Trial Details
Trial ID
NCT00349102
Start Date
July 1 2006
End Date
January 1 2014
Last Update
February 1 2017
Active Locations (7)
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1
Centre Oscar Lambret
Lille, France, 59020
2
Centre Léon Bérard
Lyon, France, 69008
3
Institut Curie
Paris, France, 75005
4
Hôpital de la Pitié Salpêtrière
Paris, France, 75013