A Phase 1 Study for Evaluating the Safety of Lattice Extreme Ablative Dose (LEAD) Radiotherapy Followed by Standard-Dose Chemoradiation for Patients With Bulky Stage III Non-Small Cell Lung Cancer
- Patients must have histologically or cytologically documented stage III non-small
cell lung cancer including squamous cell, adenocarcinoma, large cell carcinoma and
poorly differentiated non-small cell lung cancer.
- Patients must have a minimum of 4 cm of measureable disease in any one continuous
dimension as seen on diagnostic CT scan.
- Pulmonary function tests with FEV1 >= 1.45 liters/second.
- Patients must be 21 years of age or older. There is no maximum age restriction.
- Patients must have a Zubrod performance status of 0 or 1.
- Patients must have normal organ and marrow function as defined below:
- leukocyte > 3,000/:I
- absolute neutrophil count >1,500/:1
- platelets >100,000/:1
- bilirubin within normal institutional limits
- AST(SGOT)/ALT(SGPT) 2.5 X institutional upper limit of normal
- Creatinine within normal institutional limits OR creatinine clearance > 60
mL/min/1.73 m2 for patients with creatinine levels above institutional normal.
- Patients must have weight loss ≤ 10% over the past three months.
- Women of child-bearing potential and men will be asked to use adequate contraception.
- Patients must have the ability to understand and the willingness to sign a written
informed consent document.
- Patients may not have had prior thoracic radiation at any time, or prior chemotherapy
for the study cancer at any time.
- Patients may not be receiving any other investigational agents for the study cancer.
- Patients may not have evidence of brain metastases on baseline CT scan or MRI.
- Patients may not have measurable gross disease in the thorax <4 cm in any one
- Patients may not have a cytologically positive pleural effusion.
- Patients may not have a prior invasive malignancy (unless disease-free for at least 3
- Patients may not have had surgical resection of the present cancer.
- Women who are pregnant or breastfeeding will be excluded.
- Patients must not have any co-morbidity with life expectancy ≤ 6 months, or any
uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
- Patients must not have severe lung disease defined by a history of severe COPD
requiring 3 or more hospitalizations over the past year, or history of interstitial
- Patients must not have any concurrent active malignancy.
- Patients must not have evidence of metastatic disease.