Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2025-12-25 @ 3:48 AM
NCT ID:
NCT00349102
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00349102
Study Brief:
Protocol Section:
NCT00349102