An Evaluation of Preoperative Chemotherapy With Irinotecan and Cisplatin for Advanced, But Resectable Gastric Cancer: A Coordinated Multidisciplinary, Multicenter Study Linking Functional Imaging, Genomic Expression Profiles and Histopathology
I. To evaluate the correlation of FDG-PET/CT imaging early in the preoperative treatment
program of locally advanced gastric cancer with histologic response assessment and patient
outcome, defined as overall and progression-free survival.
I. To evaluate the efficacy and safety of preoperative chemotherapy with irinotecan and
cisplatin in the treatment of locally advanced gastric cancer.
II. To examine the biology of locally advanced gastric cancer and the response to
chemotherapy by DNA microarray technology and by histopathology.
III. To obtain preliminary data on biodistribution, dosimetry and explore the potential
clinical usefulness of FLT PET in patients with locally advanced gastric cancer undergoing a
novel combination neoadjuvant chemotherapy.
OUTLINE: This is an open-label, nonrandomized, multicenter study.
Neoadjuvant chemotherapy: Patients receive cisplatin IV over 30 minutes followed by
irinotecan IV over 30 minutes on days 1, 8, 22, and 29. Treatment repeats every 6 weeks for
2 courses in the absence of disease progression or unacceptable toxicity.
Surgery: Within 4 weeks after completion of neoadjuvant chemotherapy, patients undergo
radical subtotal or total gastrectomy with lymph node dissection.
Patients undergo fluorodeoxyglucose FDG-PET/CT at baseline. Some patients undergo additional
FDG-PET/CT scans in weeks 3 and 6. Approximately 5 patients undergo fluorothymidine
FLT-PET/CT at baseline, during week 3, and/or before surgical resection.
Patients are followed every 3 months for 2 years, every 6 months for 2 years, and then
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Histological response determined by a significant drop in FDG uptake correlates
Using a two sample t-test with 30 evaluable patients, we would be able to adequately test that the decrease in SUV early in the treatment plan is significantly different between responders and non responders.
Memorial Sloan-Kettering Cancer Center
United States: Food and Drug Administration
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