Phase III Randomized Study of Standard Versus Accelerated Hypofractionated Image-Guided Radiation Therapy (IGRT) in Patients With Stage II-III Non-Small Cell Lung Cancer and Poor Performance Status
- All patients must be willing and capable to provide informed consent to participate
in the protocol.
- Patients must have appropriate staging studies identifying them as AJCC stage II or
III non small cell lung cancer, (according to AJCC Staging, 6th edition; see appendix
III), or recurrent non small cell lung cancer. Histologic confirmation of cancer
will be required by biopsy or cytology within 6 months of study entry.
- Patients must have the potential for benefit from local therapy (at the discretion of
- The patient's Zubrod performance status must be 2 or greater OR patients with Zubrod
performance status 0-1 and weight loss >10% are considered eligible. In addition,
patients determined to be medically unfit or refusing combined modality therapy are
- Age ≥ 18.
- Patients must have measurable or evaluable disease.
- Women of childbearing potential and male participants must agree to use an effective
method of contraception.
- Patients must sign study specific informed consent prior to study entry.
- Patients must not have plans for concurrent chemoradiation therapy.
- Patients must complete all required pretreatment evaluations
- Total (aggregate) gross tumor volume > 500 cm3 (500 cc's or 0.5 Liters)
- Prior radiotherapy to the region of the study cancer that would result in direct
overlap of radiation therapy fields.
- Chemotherapy given within one week of study registration.
- Pregnant or lactating women, as treatment involves unforeseeable risks to the embryo