Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003298
Status:
COMPLETED
Last Update Posted:
2023-07-06
First Post:
1999-11-01
Brief Title:
Chemotherapy Surgery and Radiation Therapy in Treating Patients With Gastric Cancer
Sponsor:
ECOG-ACRIN Cancer Research Group
Organization:
Eastern Cooperative Oncology Group
Study Overview
Official Title:
A Phase II Trial of Neoadjuvant Paclitaxel - Cisplatin Chemotherapy Surgery and Adjuvant Radiation Therapy and 5-FULeucovorin for Gastric Cancer
Status:
COMPLETED
Status Verified Date:
2023-06
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 Radiation therapy uses high-energy x-rays to damage tumor cells Combining chemotherapy radiation therapy and surgery may kill more tumor cells E7296 was conducted to study neoadjuvant chemotherapy and postoperative chemoradiation therapy in patients diagnosed with high-risk gastric cancer using a new neoadjuvant regimen paclitaxel plus cisplatin It was hypothesized that this new neoadjuvant chemotherapy followed by surgery and chemoradiation therapy would be well tolerated and would have a high curative resection rate
Detailed Description:
OBJECTIVES
Primary objective To evaluate the tolerability and toxicity of neoadjuvant cisplatin plus paclitaxel and postoperative chemoradiation therapy with fluorouracil plus leucovorin calcium in patients with high-risk gastric cancer
Secondary objectives To assess the pathologic response of gastric tumors to neoadjuvant cisplatin plus paclitaxel chemotherapy and preliminarily assess the patterns of failure and disease free and overall survival
OUTLINE Patients receive 3 courses of preoperative neoadjuvant chemotherapy given on day 1 every 21 days Courses consist of an intravenous infusion of cisplatin and a 3 hour intravenous infusion of paclitaxel on day 1 Patients then undergo surgery for tumor removal on day 63 followed 4-6 weeks later by one course of daily intravenous bolus leucovorin calcium and fluorouracil for 5 days Chemotherapy is repeated 4-6 weeks later for the first 4 days of week 1 and the last 3 days of week 5 of radiation therapy given 5 days a week for 5 weeks Patients receive two more courses 4 weeks apart of fluorouracil and leucovorin calcium for 5 days 4-6 weeks after completing radiation treatment Patients are followed every month for the first 3 months every 3 months for the next 21 months every 6 months for the next year and annually thereafter
PROJECTED ACCRUAL Approximately 30-42 patients will be accrued over 18 months
Primary objective To evaluate the tolerability and toxicity of neoadjuvant cisplatin plus paclitaxel and postoperative chemoradiation therapy with fluorouracil plus leucovorin calcium in patients with high-risk gastric cancer
Secondary objectives To assess the pathologic response of gastric tumors to neoadjuvant cisplatin plus paclitaxel chemotherapy and preliminarily assess the patterns of failure and disease free and overall survival
OUTLINE Patients receive 3 courses of preoperative neoadjuvant chemotherapy given on day 1 every 21 days Courses consist of an intravenous infusion of cisplatin and a 3 hour intravenous infusion of paclitaxel on day 1 Patients then undergo surgery for tumor removal on day 63 followed 4-6 weeks later by one course of daily intravenous bolus leucovorin calcium and fluorouracil for 5 days Chemotherapy is repeated 4-6 weeks later for the first 4 days of week 1 and the last 3 days of week 5 of radiation therapy given 5 days a week for 5 weeks Patients receive two more courses 4 weeks apart of fluorouracil and leucovorin calcium for 5 days 4-6 weeks after completing radiation treatment Patients are followed every month for the first 3 months every 3 months for the next 21 months every 6 months for the next year and annually thereafter
PROJECTED ACCRUAL Approximately 30-42 patients will be accrued over 18 months
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 |
|---|---|---|---|
| E7296 | OTHER | None | None |
| U10CA023318 | NIH | None | None |
| NCT00003298 | REGISTRY | National Cancer Institute | httpsreporternihgovquickSearchU10CA023318 |