Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00058201
Status:
COMPLETED
Last Update Posted:
2013-12-18
First Post:
2003-04-07
Brief Title:
Two Chemotherapy Regimens Compared With Observation in Treating Patients With Completely Resected Pancreatic Cancer
Sponsor:
Royal Liverpool University Hospital
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
European Study Group For Pancreatic Cancer - Trial 3
Status:
COMPLETED
Status Verified Date:
2008-05
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 Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die It is not yet known which chemotherapy regimen is more effective or whether chemotherapy is more effective than observation in treating pancreatic cancer after surgery
PURPOSE Phase III trial to compare the effectiveness of two chemotherapy regimens with no further therapy in treating patients who have completely resected pancreatic cancer
PURPOSE Phase III trial to compare the effectiveness of two chemotherapy regimens with no further therapy in treating patients who have completely resected pancreatic cancer
Detailed Description:
OBJECTIVES
Primary
Compare the efficacy of adjuvant gemcitabine vs fluorouracil and leucovorin calcium vs observation only in patients with ampullary or other pancreatic malignancy in terms of overall survival in patients with completely resected pancreatic cancer
Secondary
Compare the toxicity of these regimens in these patients
Compare the quality of life and 5-year survival of patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to histology ductal adenocarcinoma vs ampullary or other pancreatic malignancy resection margin status and participating country Patients are randomized to 1 of 2 treatment arms Randomization for patients with ampullary or other pancreatic malignancy includes an observation arm
Arm I Patients receive leucovorin calcium IV and fluorouracil IV on days 1-5
Arm II Patients receive gemcitabine IV over 30 minutes on days 1 8 and 15
Arm III patients with ampullary or other pancreatic malignancy only Patients undergo observation
Treatment in arms I and II repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline 3 6 and 12 months and then annually for 5 years
Patients are followed every 3 months
PROJECTED ACCRUAL A total of 1030 patients with pancreatic adenocarcinoma 515 per arms I and II will be accrued for this study
Primary
Compare the efficacy of adjuvant gemcitabine vs fluorouracil and leucovorin calcium vs observation only in patients with ampullary or other pancreatic malignancy in terms of overall survival in patients with completely resected pancreatic cancer
Secondary
Compare the toxicity of these regimens in these patients
Compare the quality of life and 5-year survival of patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to histology ductal adenocarcinoma vs ampullary or other pancreatic malignancy resection margin status and participating country Patients are randomized to 1 of 2 treatment arms Randomization for patients with ampullary or other pancreatic malignancy includes an observation arm
Arm I Patients receive leucovorin calcium IV and fluorouracil IV on days 1-5
Arm II Patients receive gemcitabine IV over 30 minutes on days 1 8 and 15
Arm III patients with ampullary or other pancreatic malignancy only Patients undergo observation
Treatment in arms I and II repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline 3 6 and 12 months and then annually for 5 years
Patients are followed every 3 months
PROJECTED ACCRUAL A total of 1030 patients with pancreatic adenocarcinoma 515 per arms I and II 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 |
|---|---|---|---|
| AGITG-ESPAC-3 | None | None | None |
| RLUH-NCRI-ESPAC-3V2 | None | None | None |
| EU-20043 | None | None | None |
| CAN-NCIC-PA2 | None | None | None |