Stage IV Gastric Cancer Clinical Trial
Official title:
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
This phase II trial is studying how well giving irinotecan together with cisplatin works in treating patients who are undergoing surgical resection for locally advanced cancer of the stomach or gastroesophageal junction. Drugs used in chemotherapy, such as irinotecan and cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug and giving them before surgery may shrink the tumor so that it can be removed during surgery.
PRIMARY OBJECTIVES:
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.
SECONDARY OBJECTIVES:
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
annually thereafter.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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