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 @ 3:30 AM
Ignite Modification Date:
2025-12-25 @ 3:30 AM
NCT ID:
NCT00915005
Eligibility Criteria:
Inclusion Criteria:
1. Pathologically proven, unresected, locoregionally advanced NSCLC without evidence of hematogenous metastases (stage II-IIIB disease according to the 7th edition of the AJCC Staging Manual) with exception as defined by inclusion #2).
2. Patients with solitary brain metastasis without sign of progression in the brain at the time of registration will be eligible for this trial if there is clinical indication for concurrent chemoradiation to the primary disease in the lung.
3. Suitability for concurrent chemoradiation therapy per treating radiation oncologists or treating medical oncologist's: A) Karnofsky performance score of \>/= 70, or ECOG 0-1 B) Unintentional weight loss \</= 10% during the 3 months before study entry.
4. Receipt of induction chemotherapy followed by referral for concurrent chemoradiation is allowed for this protocol.
5. Measurable disease on chest x-ray, contrast-enhanced CT, or PET scan.
6. Locoregional recurrence after surgical resection, if suitable for definitive concurrent chemoradiation is allowed for this protocol.
7. Forced expiratory volume in the first second (FEV1) \>/= 1 liters.
8. Fluorodeoxyglucose (FDG) -PET scan within 3 months before registration. The pretreatment (diagnostic) PET/CT should, whenever possible, be performed together with the 4-D CT simulation. PET images acquired either at the time of simulation or acquired separately should be registered with the planning CT to assist in tumor delineation.
9. Standard pretreatment evaluations (as decided by treating radiation oncologist, medical oncologist, surgeons or pulmonologist), to include MRI or CT scan of the brain, contrast CT scan of the thorax and upper abdomen, Whole-body PET/CT, pulmonary function tests, lung and cardiac single proton emission computed tomography (SPECT), liver function tests (LFT), blood chemistry, renal function tests, and complete blood count.
10. Age \>/= 18 years but \</= 85 years.
11. A signed specific informed consent form before study entry.
Exclusion Criteria:
1. Small cell histology.
2. Prior thoracic radiotherapy to regions that would result in overlap of radiation therapy fields.
3. Pregnancy (female patients of childbearing potential must practice appropriate contraception).
4. Enrollment in a clinical trial that specifically excludes IGAPT treatment.
5. Body weight exceeds the weight limit of the treatment couch.
6. Oxygen dependent due to preexistent lung disease (COPD, emphysema, lung fibrosis).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT00915005
Study Brief:
Protocol Section:
NCT00915005