Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00010062
Status:
UNKNOWN
Last Update Posted:
2009-02-09
First Post:
2001-02-02
Brief Title:
Fluorouracil Plus Radiation Therapy Following Surgery in Treating Patients With Pancreatic Cancer
Sponsor:
GERCOR - Multidisciplinary Oncology Cooperative Group
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Study Of Post-Operative Concomitant Radio-Chemotherapy With A Continuous Infusion Of Flourouracil For Adjuvant Treatment Of Resected Pancreatic Cancer
Status:
UNKNOWN
Status Verified Date:
2007-04
Last Known Status:
ACTIVE_NOT_RECRUITING
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 with radiation therapy may kill more tumor cells left after surgery
PURPOSE Phase II trial to study the effectiveness of combining fluorouracil and radiation therapy in treating patients who have undergone surgery for pancreatic cancer
PURPOSE Phase II trial to study the effectiveness of combining fluorouracil and radiation therapy in treating patients who have undergone surgery for pancreatic cancer
Detailed Description:
OBJECTIVES
Determine the tolerance of adjuvant fluorouracil with concurrent radiotherapy in patients with resected pancreatic adenocarcinoma
Determine survival without local relapse in these patients treated with this regimen
Determine overall survival of these patients treated with this regimen
Determine the effectiveness of this adjuvant therapy in these patients
OUTLINE This is a multicenter study
Patients receive high-dose radiotherapy 5 days a week for 5 weeks Patients also receive low-dose radiotherapy 4 times a week during the last 2 weeks of the 5-week course of treatment Patients concurrently receive fluorouracil IV continuously for 5 weeks in the absence of disease progression or unacceptable toxicity
Patients are followed for survival
PROJECTED ACCRUAL A total of 40 patients will be accrued for this study
Determine the tolerance of adjuvant fluorouracil with concurrent radiotherapy in patients with resected pancreatic adenocarcinoma
Determine survival without local relapse in these patients treated with this regimen
Determine overall survival of these patients treated with this regimen
Determine the effectiveness of this adjuvant therapy in these patients
OUTLINE This is a multicenter study
Patients receive high-dose radiotherapy 5 days a week for 5 weeks Patients also receive low-dose radiotherapy 4 times a week during the last 2 weeks of the 5-week course of treatment Patients concurrently receive fluorouracil IV continuously for 5 weeks in the absence of disease progression or unacceptable toxicity
Patients are followed for survival
PROJECTED ACCRUAL A total of 40 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EU-20022 | None | None | None |
| FRE-GERCOR-D98-1 | None | None | None |