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:
2025-12-24 @ 7:32 PM
Ignite Modification Date:
2025-12-24 @ 7:32 PM
NCT ID:
NCT01823003
Eligibility Criteria:
Inclusion Criteria:
* Histologically-confirmed primary lung cancer or lung metastasis from another primary tumour or positive PET/CT suggestive for primary tumour(SUV MAX\> 4).
* Tumour size \< 5 cm in diameter prior to treatment.
* Medically inoperable patients as determined by the multidisciplinary thoracic tumour board, or medically operable patients who refuse surgery.
* Life expectancy of \>12 months.
* Criterion for medical inoperability include:
Overall clinical assessment at the UCLA thoracic tumour board. Reduced Pulmonary Function (FEV1, DLCO, etc) based on one major or two minor criterion as described below: Minor Criteria: Age \> 75, FEV1 51- 60% predicted, or FEV1 1-1.2L, DLCO 51%-60% predicted, pulmonary hypertension, poor left ventricular function (EF \< 40% or less), resting or exercise arterial pO2 \< 55 mmHg, and pCO2 \> 45 mmHg.
* Age \> 18 years.
* KPS \> 70.
* Barthel score \>40
* Baseline computed tomography scans of the chest, pulmonary test function, and positron emission tomography no more than 2 months before treatment.
* If a woman is of childbearing potential, a negative urine or serum pregnancy test must be documented.
* Ability to understand and the willingness to sign a written informed consent.
Exclusion Criteria:
* Prior thoracic radiation treatment wich dose contribution can be expected in the new SBRT plan.
* More than two lesions per lobe.
* Active infections requiring systemic antibiotics.
* Age \<18 years old.
* KPs \< 70.
* Barthel Total Score \< 40.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01823003
Study Brief:
Protocol Section:
NCT01823003