Lung Cancer Clinical Trial
Official title:
A Phase II Trial of Combined Modality Therapy With Growth Factor Support for Patients With Limited Stage Small Cell Lung Cancer
RATIONALE: 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. Radiation therapy uses high-energy x-rays to kill tumor cells. Colony-stimulating
factors, such as G-CSF or pegfilgrastim, may increase the number of immune cells found in
bone marrow or peripheral blood and may help the immune system recover from the side effects
of chemotherapy and radiation therapy.
PURPOSE: This phase II trial is studying G-CSF and pegfilgrastim to see how well they work in
treating neutropenia in patients undergoing combination chemotherapy and radiation therapy
for limited stage small cell lung cancer.
OBJECTIVES:
Primary
- To evaluate the safety and efficacy of filgrastim (G-CSF) in reducing grade 4
neutropenia or grades 3-4 febrile neutropenia in patients with limited stage small cell
lung cancer treated with radiotherapy and concurrent chemotherapy comprising cisplatin
and etoposide.
Secondary
- To evaluate the safety and efficacy of pegfilgrastim in reducing grade 4 neutropenia or
grades 3-4 febrile neutropenia in patients treated with adjuvant chemotherapy comprising
cisplatin and etoposide.
- To estimate the incidence of dose modifications or treatment delays in patients treated
with this regimen.
- To estimate the incidence of esophagitis, pneumonitis, and other non-hematological
adverse events in patients treated with this regimen.
- To estimate the incidence of grade 4 thrombocytopenia in patients treated with this
regimen.
- To estimate the median and two-year rate of progression-free and overall survival of
patients treated with this regimen.
After completion of study therapy, patients are followed every 3 months for one year, every 6
months for 2-3 years, and then annually for up to 5 years.
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