A Phase II Trial of Combined Modality Therapy With Growth Factor Support for Patients With Limited Stage Small Cell Lung Cancer
- 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
- 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
- To estimate the median and two-year rate of progression-free and overall survival of
patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients undergo thoracic radiotherapy once daily on days 1-5 of weeks 1-3 and twice daily
on days 1-5 of weeks 4 and 5 for a total of 16 fractions. Patients also receive concurrent
chemotherapy comprising cisplatin IV on day 1 and etoposide IV on days 1-3. Chemotherapy
repeats every 3 weeks for 2 courses. Patients receive filgrastim (G-CSF) subcutaneously (SC)
on days 4-13 and 25-34.
After completion of chemoradiotherapy, patients receive adjuvant chemotherapy comprising
cisplatin IV on day 1 and etoposide IV on days 2 and 3. Adjuvant therapy repeats every 21
days for up to 2 courses in the absence of disease progression or unacceptable toxicity.
Patients also receive pegfilgrastim SC on day 4 of each course of adjuvant therapy.
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.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Incidence of grade 4 neutropenia or grades 3-4 febrile neutropenia episodes during concurrent chemoradiotherapy as assessed by NCI CTCAE v 3.0
At the completion of all treatment, approximately 80 days
Rogerio C. Lilenbaum, MD
Mount Sinai Comprehensive Cancer Center at Mount Sinai Medical Center
United States: Federal Government
|CCOP - Mount Sinai Medical Center||Miami Beach, Florida 33140|
|Charles M. Barrett Cancer Center at University Hospital||Cincinnati, Ohio 45267-0526|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins||Baltimore, Maryland 21231-2410|
|Cleveland Clinic Taussig Cancer Center||Cleveland, Ohio 44195|
|McDowell Cancer Center at Akron General Medical Center||Akron, Ohio 44307|
|University of Florida Shands Cancer Center||Gainesville, Florida 32610-0232|
|Northern Rockies Radiation Oncology Center||Billings, Montana 59101|
|Lucille P. Markey Cancer Center at University of Kentucky||Lexington, Kentucky 40536-0093|
|Methodist Estabrook Cancer Center||Omaha, Nebraska 68114-4199|
|Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford||Salem, Ohio 44460|
|Cancer Treatment Center||Wooster, Ohio 44691|
|Summa Center for Cancer Care at Akron City Hospital||Akron, Ohio 44309-2090|
|McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center||Reading, Pennsylvania 19612-6052|
|Veterans Affairs Medical Center - Milwaukee||Milwaukee, Wisconsin 53295|