Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003049
Status:
COMPLETED
Last Update Posted:
2016-12-22
First Post:
1999-11-01
Brief Title:
Surgery Followed by Radiation Therapy and Chemotherapy in Treating Patients With Cancer of the Pancreas
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
A Prospective Randomized Trial of Extended Lymphadenectomy in the Management of Resectable Pancreatic Cancer
Status:
COMPLETED
Status Verified Date:
2011-05
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 Surgery to remove the pancreas some of the small intestine and lymph nodes may be more effective treatment for cancer of the pancreas than surgery to remove the pancreas and some of the small intestine alone Radiation therapy uses high-energy x-rays to damage tumor cells Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining surgery radiation therapy and chemotherapy may be an effective treatment for cancer of the pancreas
PURPOSE Randomized phase III trial to compare the effectiveness of surgery to remove the pancreas and a portion of the small intestine with or without removing lymph nodes followed by radiation therapy and chemotherapy in treating patients with cancer of the pancreas
PURPOSE Randomized phase III trial to compare the effectiveness of surgery to remove the pancreas and a portion of the small intestine with or without removing lymph nodes followed by radiation therapy and chemotherapy in treating patients with cancer of the pancreas
Detailed Description:
OBJECTIVES
Assess the overall survival of patients with resectable ductal pancreatic adenocarcinoma undergoing extended versus standard pancreatoduodenectomy
OUTLINE Patients are randomized to undergo standard pancreatoduodenectomy PD or PD with extended lymph node resection after an exploratory laparotomy
Patients receive adjuvant chemoradiation therapy 4-6 weeks after surgery if no metastases are evident Radiation therapy is given every week for 5 weeks Fluorouracilleucovorin calcium is administered by rapid IV push daily within 2 hours of radiation on days 1-4 of week 1 and days 29-31 of week 5
Patients are followed every 4 months for the first year then every 6 months for the next 2 years
PROJECTED ACCRUAL 50 patients will be accrued per group for a total of 100 patients
Assess the overall survival of patients with resectable ductal pancreatic adenocarcinoma undergoing extended versus standard pancreatoduodenectomy
OUTLINE Patients are randomized to undergo standard pancreatoduodenectomy PD or PD with extended lymph node resection after an exploratory laparotomy
Patients receive adjuvant chemoradiation therapy 4-6 weeks after surgery if no metastases are evident Radiation therapy is given every week for 5 weeks Fluorouracilleucovorin calcium is administered by rapid IV push daily within 2 hours of radiation on days 1-4 of week 1 and days 29-31 of week 5
Patients are followed every 4 months for the first year then every 6 months for the next 2 years
PROJECTED ACCRUAL 50 patients will be accrued per group for a total of 100 patients
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 |
|---|---|---|---|
| 152-97 | OTHER | Mayo Clinic IRB | httpsreporternihgovquickSearchP30CA015083 |
| P30CA015083 | NIH | None | None |
| 974301 | OTHER | None | None |
| G97-1302 | OTHER | None | None |