Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002783
Status:
COMPLETED
Last Update Posted:
2013-07-03
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy Before and After Surgery in Treating Patients With Stomach Cancer
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
A PHASE II TRIAL OF NEOADJUVANT CISPLATIN-FLUOROURACIL CHEMOTHERAPY SURGERY AND INTRAPERITONEAL IP FLOXURIDINE FUdR PLUS LEUCOVORIN IN PATIENTS WITH GASTRIC CANCER
Status:
COMPLETED
Status Verified Date:
2013-07
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:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining more than one drug and giving them in different ways may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of chemotherapy before and after surgery in treating patients with high-risk stomach cancer
PURPOSE Phase II trial to study the effectiveness of chemotherapy before and after surgery in treating patients with high-risk stomach cancer
Detailed Description:
OBJECTIVES I Evaluate the efficacy and toxicity of neoadjuvant cisplatinfluorouracil CDDP5-FU followed by surgery followed by adjuvant intraperitoneal floxuridineleucovorin in patients with high-risk gastric cancer II Assess the quality of life and cost-benefit ratio associated with this treatment III Evaluate the sensitivity specificity and overall staging accuracy of laparoscopy with or without laparoscopic ultrasound in predicting the resectability rate with and without neoadjuvant CDDP5-FU response to chemotherapy and accuracy when compared to pathologic findings IV Correlate the presence of mutated vs wild-type p53 suppressor oncogenes in endoscopic biopsies and resected tumor specimens with clinical outcome defined as downstaging failure pattern and disease-free and overall survival in patients treated with and without neoadjuvant CDDP5-FU
OUTLINE The following acronyms are used CDDP Cisplatin NSC-119875 CF Leucovorin calcium NSC-3590 5-FU Fluorouracil NSC-19893 FUDR Floxuridine NSC-27640 2-Drug Combination Chemotherapy followed by Surgery followed by Single-Agent Chemotherapy with Drug Modulation CDDP5-FU followed by total or subtotal radical gastrectomy with D2 dissection followed by FUDR with CF
PROJECTED ACCRUAL A total of 50 patients will be entered over 2-25 years
OUTLINE The following acronyms are used CDDP Cisplatin NSC-119875 CF Leucovorin calcium NSC-3590 5-FU Fluorouracil NSC-19893 FUDR Floxuridine NSC-27640 2-Drug Combination Chemotherapy followed by Surgery followed by Single-Agent Chemotherapy with Drug Modulation CDDP5-FU followed by total or subtotal radical gastrectomy with D2 dissection followed by FUDR with CF
PROJECTED ACCRUAL A total of 50 patients will be entered over 2-25 years
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 |
|---|---|---|---|
| NCI-H96-0916 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000064831 | REGISTRY | None | None |