Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00010166
Status:
COMPLETED
Last Update Posted:
2021-09-09
First Post:
2001-02-02
Brief Title:
Gemcitabine and Radiation Therapy in Treating Patients With Cancer of the Pancreas
Sponsor:
Wake Forest University Health Sciences
Organization:
Wake Forest University Health Sciences
Study Overview
Official Title:
Phase II Trial Of Adjuvant 22-Difluoro-2-Deoxycytidine Gemcitabine And External Beam Radiation For The Treatment Of Resectable 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 Radiation therapy uses high-energy x-rays to damage tumor cells Gemcitabine may make tumor cells more sensitive to radiation therapy Combining chemotherapy with radiation therapy after surgery may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combining gemcitabine with radiation therapy in treating patients who have undergone surgery to remove cancer of the pancreas
PURPOSE Phase II trial to study the effectiveness of combining gemcitabine with radiation therapy in treating patients who have undergone surgery to remove cancer of the pancreas
Detailed Description:
OBJECTIVES
Determine the time to disease progression local control and survival of patients with previously resected pancreatic cancer treated with adjuvant gemcitabine and radiotherapy
OUTLINE This is a multicenter study
Patients receive gemcitabine IV over 30-60 minutes on days 1 4 8 11 15 18 22 25 29 and 32 and undergo radiotherapy on days 1-5 8-12 15-19 22-26 29-33 and 36-38 in the absence of disease progression or unacceptable toxicity
Beginning at least 4 weeks after chemoradiotherapy patients without disease progression and with less than 10 weight loss during study receive additional gemcitabine IV over 30 minutes on days 1 8 and 15 Treatment repeats every 28 days for a total of 2 courses
Patients are followed every 8 weeks for 6 months and then every 3 months for up to 2 years
PROJECTED ACCRUAL A total of 72 patients will be accrued for this study within 22 or 34 years
Determine the time to disease progression local control and survival of patients with previously resected pancreatic cancer treated with adjuvant gemcitabine and radiotherapy
OUTLINE This is a multicenter study
Patients receive gemcitabine IV over 30-60 minutes on days 1 4 8 11 15 18 22 25 29 and 32 and undergo radiotherapy on days 1-5 8-12 15-19 22-26 29-33 and 36-38 in the absence of disease progression or unacceptable toxicity
Beginning at least 4 weeks after chemoradiotherapy patients without disease progression and with less than 10 weight loss during study receive additional gemcitabine IV over 30 minutes on days 1 8 and 15 Treatment repeats every 28 days for a total of 2 courses
Patients are followed every 8 weeks for 6 months and then every 3 months for up to 2 years
PROJECTED ACCRUAL A total of 72 patients will be accrued for this study within 22 or 34 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
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-104 | None | None | None |
| CCCWFU-57198 | None | None | None |