Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00062374
Status:
COMPLETED
Last Update Posted:
2017-07-06
First Post:
2003-06-05
Brief Title:
Irinotecan and Cisplatin in Treating Patients Who Are Undergoing Surgery For Locally Advanced Cancer of the Stomach or Gastroesophageal Junction
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2017-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
PRIMARY OBJECTIVES
I To evaluate the correlation of fluorodeoxyglucose FDG positron emission tomography PETcomputed tomography 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 fluorodeoxythymidine 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 intravenously 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-PETCT at baseline Some patients undergo additional FDG-PETCT scans in weeks 3 and 6 Approximately 5 patients undergo fluorothymidine FLT-PETCT at baseline during week 3 andor before surgical resection
Patients are followed up every 3 months for 2 years every 6 months for 2 years and then annually thereafter
I To evaluate the correlation of fluorodeoxyglucose FDG positron emission tomography PETcomputed tomography 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 fluorodeoxythymidine 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 intravenously 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-PETCT at baseline Some patients undergo additional FDG-PETCT scans in weeks 3 and 6 Approximately 5 patients undergo fluorothymidine FLT-PETCT at baseline during week 3 andor before surgical resection
Patients are followed up every 3 months for 2 years every 6 months for 2 years and then annually thereafter
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P30CA008748 | NIH | CTEP | httpsreporternihgovquickSearchP30CA008748 |
| NCI-2012-01438 | REGISTRY | None | None |
| NCI-5917 | None | None | None |
| CDR0000304738 | None | None | None |
| MSKCC-03032 | None | None | None |
| 03-032 | OTHER | None | None |
| 5917 | OTHER | None | None |