Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003029
Status:
COMPLETED
Last Update Posted:
2012-07-02
First Post:
1999-11-01
Brief Title:
Fluorouracil With or Without Cisplatin in Treating Patients With Advanced or Metastatic Cancer of the Pancreas
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
Infusional 5-Fluorouracil With or Without Cisplatin and With or Without Chronomodulation Against Locally-Advanced or Metastatic Pancreatic Cancer A Multicenter Randomized Phase III Trial
Status:
COMPLETED
Status Verified Date:
2012-06
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 Combining more than one drug and giving drugs in different ways may kill more tumor cells It is not yet known whether fluorouracil plus cisplatin are more effective than fluorouracil alone in treating patients with metastatic cancer of the pancreas
PURPOSE Randomized phase III trial to compare the effectiveness of fluorouracil with or without cisplatin in treating patients who have advanced or metastatic cancer of the pancreas
PURPOSE Randomized phase III trial to compare the effectiveness of fluorouracil with or without cisplatin in treating patients who have advanced or metastatic cancer of the pancreas
Detailed Description:
OBJECTIVES
Confirm the value of chronomodulated infusion with respect to survival in patients with locally advanced or metastatic pancreatic cancer
Test the value of adding cisplatin to fluorouracil in extending survival in these patients
OUTLINE This is a multicenter randomized study
The study design is a 2 X 2 factorial such that patients are allocated to one of 4 treatment groups involving the use or absence of chronomodulation and cisplatin CDDP Treatment in each of the 4 groups is repeated for 3 courses where each course is a 5-day course of treatment
Patients in the first group receive a chronomodulated schedule based on delivery of fluorouracil FU Patients in the second group receive a chronomodulated schedule of FU and CDDP Patients in the third and fourth experimental groups receive flat schedules of FU alone or FU and CDDP respectively Dosages of FU are increased across the three courses whereas dosages of CDDP remain constant
Treatment is continued until disease progression severe toxicity or complete remission for more than 4 months occurs
PROJECTED ACCRUAL 200 patients will be accrued
Confirm the value of chronomodulated infusion with respect to survival in patients with locally advanced or metastatic pancreatic cancer
Test the value of adding cisplatin to fluorouracil in extending survival in these patients
OUTLINE This is a multicenter randomized study
The study design is a 2 X 2 factorial such that patients are allocated to one of 4 treatment groups involving the use or absence of chronomodulation and cisplatin CDDP Treatment in each of the 4 groups is repeated for 3 courses where each course is a 5-day course of treatment
Patients in the first group receive a chronomodulated schedule based on delivery of fluorouracil FU Patients in the second group receive a chronomodulated schedule of FU and CDDP Patients in the third and fourth experimental groups receive flat schedules of FU alone or FU and CDDP respectively Dosages of FU are increased across the three courses whereas dosages of CDDP remain constant
Treatment is continued until disease progression severe toxicity or complete remission for more than 4 months occurs
PROJECTED ACCRUAL 200 patients will be accrued
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 |
|---|---|---|---|
| EORTC-05962 | None | None | None |