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:
NCT00520702
Eligibility Criteria:
Inclusion Criteria:
1. Pathologically proven diagnosis of unresected loco-regionally advanced non-small cell lung cancer without evidence of hematogenous metastases, Stages IIB-IIIB without contralateral hilar nodal disease.
2. Patient is suitable for concurrent chemoradiation therapy per treating physician's assessment (kps \>/= 70, weight loss \< 10% in three months prior to diagnosis).
3. Patients with Stage IV NSCLC with solitary metastasis (brain, one side of adrenal gland, or one site of bone), who have clinical indication of concurrent chemoradiation to the primary disease in the lung are eligible.
4. Patients who received induction chemotherapy and then referred for concurrent chemoradiation are eligible.
5. Patients who had local regional recurrence after surgical resection and who are suitable for definitive concurrent chemoradiation are eligible.
6. Measurable disease by chest x-ray and/or contrast-enhanced CT, and/or PET scan
7. FEV 1\> 1000 cc
8. Pre-chemoradiation FDG-PET within 10 weeks prior to randomization. This PET/CT is a standard procedure for staging. It is strongly encouraged to have this PET/CT performed at the same time for 4-D CT simulation using the 4-D PET/CT scanner at the department of radiation oncology.
9. Patient will undergo routine standard pretreatment evaluations as decided by treating physician, which usually include magnetic resonance imaging (MRI) or CT of the brain, contrast CT scan of the thorax and upper abdomen, pulmonary functional test, single-photon emission computerized tomography (SPECT), liver function tests (LFT), blood chemistry, renal functional test, complete blood count.
10. Age \> 18, \< 80 years
11. Patient must sign study specific informed consent prior to study entry.
Exclusion Criteria:
1. Evidence of small cell histology
2. Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
3. Pregnant women are ineligible as the treatment involves unforeseeable risks to the participant and to the embryo or fetus. Patients with childbearing potential must practice appropriate contraception.
4. Patient has enrolled in a clinical trial that specifically does not allow IMRT treatment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT00520702
Study Brief:
Protocol Section:
NCT00520702