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 @ 2:59 AM
Ignite Modification Date:
2025-12-25 @ 2:59 AM
NCT ID:
NCT02473133
Eligibility Criteria:
Inclusion Criteria:
* Male or female patients,
* Age over 18 years and below 75-year-old,
* Good general condition: WHO performance status ≤ 1,
* Histological evidence of non-small cell lung cancer,
* Measureable tumour according to RECIST 1.1 evaluation criteria,
* Mediastinoscopy or endobronchial ultrasound to prove the histological stage N2/N3,
* Patient eligible to curative-intent radio-chemotherapy,
* Absence of pleural involvement, of pulmonary or extra-thoracic metastatic localisation,
* Absence of co-morbidity contra-indicating radio-chemotherapy,
* Lung function: FEV1 ≥ 40% of theoretical value and DLCO/VA ≥ 60% of theoretical value and PaO2 ≥ 60 mm Hg,
* Tumour FDG uptake higher than mediastinal background noise on baseline PET/CT,
* Haematological parameters:
* Neutrophil count ≥ 1.5x109/L and platelet count ≥ 100x109/L,
* Haemoglobin ≥ 9 g/dL,
* Provisional RT plan confirming that the dose objectives (minimal dose of 62.7 Gy (95% of the prescribed dose) in 98% of target volumes and 70.3 Gy for the "boosted" volume at 74 Gy) and constraints (lungs, spinal cord) are met (ICRU83),
* Estimated creatinine clearance ≥ 60 mL/min,
* Signed informed consent
* Affiliated or beneficiary of a social benefit system
Exclusion Criteria:
* Histology other than non-small cell lung cancer,
* Absence of FDG uptake on FDG-PET/CT scan before induction chemotherapy,
* Patients for whom curative radiotherapy is not indicated (tumour extension, metastases, general condition, co-morbidities),
* Significant interstitial disease on CT scan,
* Previous neoplastic disease of less than 5 years duration or progressive (without basal cell carcinoma of the skin, in situ carcinoma of the cervix),
* Previous thoracic radiotherapy,
* Patient enrolled in another therapeutic trial,
* Pregnant women or women of child-bearing potential or breast feeding mothers,
* Adult subjects who are under protective custody or guardianship,
* Patient unable to comply with the specific obligations of the study (geographic, social or physical reasons),
* Uncontrolled diabetes with blood glucose ≥10 mmol/L,
* Hypersensitivity to the active substance (FDG) or to any of the excipients,
* Patients unable to understand the purpose of the study (language, etc.).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02473133
Study Brief:
Protocol Section:
NCT02473133