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| Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00062374 |
Purpose
RATIONALE: 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.
PURPOSE: 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.
| Condition | Intervention | Phase |
|
Gastric Cancer |
Drug: cisplatin Drug: fludeoxyglucose F 18 Drug: irinotecan hydrochloride Procedure: computed tomography Procedure: conventional surgery Procedure: neoadjuvant therapy Procedure: positron emission tomography |
Phase II |
| MedlinePlus related topics: | Cancer Stomach Cancer |
| Drug Information available for: | Cisplatin Irinotecan Irinotecan hydrochloride Fluorodeoxyglucose F18 |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| 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 |
| Estimated Enrollment: | 40 |
| Study Start Date: | June 2003 |
OBJECTIVES:
OUTLINE: This is an open-label, nonrandomized, multicenter study.
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.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 10 months.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the stomach or gastroesophageal (GE) junction
Locally advanced disease that is potentially curable by surgery
No metastatic disease
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
No concurrent vitamins, antioxidants, or herbal preparations or supplements
Contacts and Locations| United States, New York | |||||
| Memorial Sloan-Kettering Cancer Center | |||||
| New York, New York, United States, 10021 | |||||
| United States, Pennsylvania | |||||
| Fox Chase Cancer Center - Philadelphia | |||||
| Philadelphia, Pennsylvania, United States, 19111-2497 | |||||
| Memorial Sloan-Kettering Cancer Center |
| National Cancer Institute (NCI) |
| Study Chair: | Manish A. Shah, MD | Memorial Sloan-Kettering Cancer Center |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
|
Shah MA, Yeung H, Coit D, et al.: A phase II study of preoperative chemotherapy with irinotecan(CPT) and cisplatin(CIS) for gastric cancer (NCI 5917): FDG-PET/CT predicts patient outcome. [Abstract] J Clin Oncol 25 (Suppl 18): A-4502, 2007.
  |
| Study ID Numbers: | CDR0000304738, MSKCC-03032, NCI-5917 |
| First Received: | June 5, 2003 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00062374 |
| Health Authority: | United States: Federal Government |
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