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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
This phase I trial studies the side effects and best dose of radiation therapy when given together with cisplatin and etoposide in treating patients with non-small cell lung cancer that cannot be removed by surgery. Radiation therapy uses high energy x rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Drugs, such as cisplatin, may make tumor cells more sensitive to radiation therapy. Giving radiation therapy together with cisplatin and etoposide may kill more tumor cells
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 treatments
Other exclusion criteria may apply.
Lung Cancer; Solid Tumors
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