Evaluation of the Interest of Breath Holding for the Prevention of Radiation Pneumonitis Following Conformal Radiation Therapy
18 Years
N/A
Both
Carcinoma, Non-small-cell Lung
Trial Information
Evaluation of the Interest of Breath Holding for the Prevention of Radiation Pneumonitis Following Conformal Radiation Therapy
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Clinical, functional and radiological evaluations at 6-8 weeks and 10-12 weeks after the end of irradiation
Outcome Time Frame:
6-8 and 10-12 weeks after the end of irradiation
Safety Issue:
No
Principal Investigator
Line CLAUDE, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Centre Leon Berard, Lyon
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
GATING 2006
NCT ID:
NCT00349102
Start Date:
July 2006
Completion Date:
July 2013
Related Keywords:
- Carcinoma, Non-Small-Cell Lung
- Non-small-cell lung cancer
- Breath-hold
- Radiation pneumonitis
- Serum cytokines
- LENT-SOMA scale
- Non-metastatic non-small-cell lung cancer
- Carcinoma
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
- Pneumonia
- Radiation Pneumonitis
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