Multimodality Therapy for Stages II and III Non-Small Cell Lung Cancer: Surgical Resection Followed by Sequential Administration of Gemcitabine Plus Cisplatin Chemotherapy and Radiation Therapy
- To assess overall survival and progression-free survival of patients with stage II-IIIB
non-small cell lung cancer undergoing surgical resection, followed by adjuvant
chemotherapy comprising gemcitabine and cisplatin, and radiotherapy.
- To assess the toxicities of this regimen in these patients.
- To evaluate the mRNA expression of enzymes (i.e., excision repair cross complementing
protein, ribonucleotide reductase, and cytidine/deoxycytidine deaminase and kinase),
which may be important in regulating the cytotoxicity of gemcitabine and cisplatin in
- To correlate mRNA levels with progression-free survival of patients treated with this
- To assess BCL2, P53, and HER2-neu expression by IHC and correlation with
OUTLINE: Patients undergo surgical resection of their tumor and mediastinal lymph node
dissection. Patients with complete surgical eradication of their disease or pathologic
evidence of microscopic residual disease proceed to adjuvant chemotherapy.
Within approximately 60 days after surgical resection, patients receive adjuvant
chemotherapy comprising gemcitabine IV over 30 minutes on days 1 and 8 and cisplatin IV over
1 hour on day 8. Treatment repeats every 21 days for up to 3 courses in the absence of
disease progression or unacceptable toxicity.
Beginning 130-144 days after surgery, patients undergo radiotherapy once daily, five days a
week, for approximately 6 weeks.
Tumor tissue specimens are obtained at the time of surgical resection for pharmacodynamic
and biomarker correlative studies. Specimens are examined by reverse
transcriptase-polymerase chain reaction to measure mRNA expression of target oncogenes
(i.e., DNA repair gene ERCC-1 and M2 subunit of the DNA repair gene ribonucleotide
reductase) and enzymes (i.e., cytidine/deoxycytidine deaminase and kinase). Resected
specimens are also assessed by IHC for the expression of BCL2, P53, and HER2-neu genes.
After completion of study therapy, patients are followed every 6 months for 5 years and
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Relapse-free survival from the date of surgery
Marianna Koczywas, MD
Beckman Research Institute
United States: Federal Government