Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006038
Status:
COMPLETED
Last Update Posted:
2013-06-19
First Post:
2000-07-05
Brief Title:
Combination Chemotherapy Followed by Surgery and Intraperitoneal Chemotherapy in Treating Patients With Locally Advanced 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-Docetaxel Chemotherapy Surgery and Intraperitoneal IP Floxuridine FUdR Plus Leucovorin in Patients With Locally Advanced Gastric Cancer
Status:
COMPLETED
Status Verified Date:
2013-06
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:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Giving chemotherapy drugs in different ways may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy followed by surgery and intraperitoneal chemotherapy in treating patients who have locally advanced stomach cancer
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy followed by surgery and intraperitoneal chemotherapy in treating patients who have locally advanced stomach cancer
Detailed Description:
OBJECTIVES I Determine the efficacy and toxicity of neoadjuvant cisplatin fluorouracil and docetaxel and postoperative intraperitoneal floxuridine and leucovorin calcium in patients with locally advanced adenocarcinoma of the stomach or gastroesophageal junction II Determine whether molecular markers including thymidylate synthase excision repair cross complementing gene and tubulin isoform 4B for sensitivity to fluorouracil cisplatin and docetaxel respectively are predictive of outcome disease free survival and overall survival in these patients III Determine the quality of life of these patients treated with this regimen
OUTLINE During weeks 1 and 4 patients receive docetaxel IV over 1 hour followed by cisplatin IV over 30-60 minutes on day 1 and fluorouracil IV continuously on days 1-5 During weeks 6-8 patients undergo radical subtotal or total gastrectomy with a D2 lymph node dissection followed by percutaneous placement of an intraperitoneal port device Beginning within 5 days after resection patients with clear margins receive floxuridine and leucovorin calcium intraperitoneally on days 1-3 during weeks 1 3 and 5 in the absence of disease progression or unacceptable toxicity Quality of life is assessed prior to beginning study prior to surgery then monthly for 3 months beginning after completion of study therapy then every 3 months through year 2 and then every 6 months through year 3 Patients are followed monthly for 3 months then every 3 months through year 2 and then every 6 months though year 3
PROJECTED ACCRUAL A total of 50 patients will be accrued for this study within 25 years
OUTLINE During weeks 1 and 4 patients receive docetaxel IV over 1 hour followed by cisplatin IV over 30-60 minutes on day 1 and fluorouracil IV continuously on days 1-5 During weeks 6-8 patients undergo radical subtotal or total gastrectomy with a D2 lymph node dissection followed by percutaneous placement of an intraperitoneal port device Beginning within 5 days after resection patients with clear margins receive floxuridine and leucovorin calcium intraperitoneally on days 1-3 during weeks 1 3 and 5 in the absence of disease progression or unacceptable toxicity Quality of life is assessed prior to beginning study prior to surgery then monthly for 3 months beginning after completion of study therapy then every 3 months through year 2 and then every 6 months through year 3 Patients are followed monthly for 3 months then every 3 months through year 2 and then every 6 months though year 3
PROJECTED ACCRUAL A total of 50 patients will be accrued for this study within 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-G00-1813 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000068053 | REGISTRY | None | None |