Return to search results.
Complete title: A Phase I dose-intensification study using radiation therapy and concurrent cisplatin and etoposide for patients with inoperable non-small cell lung cancer
|Research Study Number||7506|
|Principal Investigator||Shilpen Patel, MD|
Research Study Description
Eligibility Criteria (must meet the following to participate in this study)
- Patients with confirmed unresectable Stage IIB or Stage III non-small cell lung cancer of any histologic-subtype appropriate for definitive concurrent chemotherapy and radiation as determined by multi-disciplinary assessment; all detectable tumor should be encompassable by radiation therapy fields, including both the primary tumor and the involved regional lymph nodes
- Granulocytes >= 1500/ul
- Platelets >= 100,000/ul
- Bilirubin < 1.5 mg/dl
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) < 2 upper limit of normal (ULN)
- Creatinine clearance must be > 60ml/min
- Eastern Cooperative Oncology Group (ECOG) 0 to 1
- Weight loss =< 5% in the previous six months unless weight loss is intentional (per judgment of study medical doctor [MD])
- Forced expiratory volume in one second (FEV1) must be >= 1.0 L
- Patients must sign a study-specific informed consent form prior to study entry
- Patients must have measurable disease on the 3D planning computed tomography (CT)
- Patient must have a completed 3D plan and the attending physician must have reviewed and approved the dose volume histograms as follows: total lung volume percentage receiving at least 20 Gy (V20) =< 35%, and mean lung dose =< 20 Gy
Other eligibility criteria may apply.
Exclusions (conditions that would prevent participation in this study)
- Concurrent malignancy except non-melanomatous skin cancer or prior cancer if disease-free for one year or more
- Patients with malignant pleural effusions or significant pericardial effusions
- Pregnant or lactating females
- Severe neuropathy greater than or equal to grade 2
- Severe sensorineural hearing loss greater or equal to grade 2
- No clinically significant history of cardiac disease, (i.e. uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the past year, or cardiac ventricular arrhythmias requiring medication)
- Any significant or severe medical conditions or psychiatric or social conditions that would preclude adherence to the protocol or compliance with study
Other exclusion criteria may apply.
Lung Cancer; Solid Tumors
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.