Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00025168
Status:
COMPLETED
Last Update Posted:
2021-09-09
First Post:
2001-10-11
Brief Title:
Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Locally Advanced Unresectable Pancreatic Cancer
Sponsor:
Wake Forest University Health Sciences
Organization:
Wake Forest University Health Sciences
Study Overview
Official Title:
Phase II Trial Of Induction GemcitabineCPT-11 Followed By Twice-Weekly Infusion Gemcitabine And Concurrent External Beam Radiation For The Treatment Of Locally Advanced Pancreatic Cancer
Status:
COMPLETED
Status Verified Date:
2021-09
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 such as gemcitabine and irinotecan work in different ways to stop tumor cells from dividing so they stop growing or die Combining radiation therapy with chemotherapy may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy and radiation therapy in treating patients who have locally advanced unresectable pancreatic cancer
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy and radiation therapy in treating patients who have locally advanced unresectable pancreatic cancer
Detailed Description:
OBJECTIVES
Determine the time to progression local control and survival of patients with locally advanced unresectable pancreatic cancer treated with induction gemcitabine and irinotecan followed by gemcitabine and concurrent radiotherapy
OUTLINE Patients receive induction gemcitabine IV over 30 minutes and irinotecan IV over 90 minutes on days 1 and 8 Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity
Within 2 weeks of completing induction chemotherapy patients receive gemcitabine IV over 30-60 minutes on days 1 4 8 11 15 18 22 25 29 and 32 Patients undergo concurrent radiotherapy 5 days a week for 55 weeks
Patients are followed every 8 weeks for 6 months and then every 3 months for 15 years
PROJECTED ACCRUAL Approximately 60-120 patients will be accrued for this study within 1-2 years
Determine the time to progression local control and survival of patients with locally advanced unresectable pancreatic cancer treated with induction gemcitabine and irinotecan followed by gemcitabine and concurrent radiotherapy
OUTLINE Patients receive induction gemcitabine IV over 30 minutes and irinotecan IV over 90 minutes on days 1 and 8 Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity
Within 2 weeks of completing induction chemotherapy patients receive gemcitabine IV over 30-60 minutes on days 1 4 8 11 15 18 22 25 29 and 32 Patients undergo concurrent radiotherapy 5 days a week for 55 weeks
Patients are followed every 8 weeks for 6 months and then every 3 months for 15 years
PROJECTED ACCRUAL Approximately 60-120 patients will be accrued for this study within 1-2 years
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 |
|---|---|---|---|
| NCI-5332 | None | None | None |
| CCCWFU-57100 | None | None | None |