Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003546
Status:
COMPLETED
Last Update Posted:
2016-07-20
First Post:
1999-11-01
Brief Title:
Gemcitabine Plus Radiation Therapy in Treating Patients With Pancreatic Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
Phase II Chemoradiation Trial Using Gemcitabine in Patients With Locoregional Adenocarcinoma of the Pancreas
Status:
COMPLETED
Status Verified Date:
2016-07
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 Radiation therapy uses high-energy x-rays to damage tumor cells Combining chemotherapy with radiation therapy may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of gemcitabine plus radiation therapy in treating patients with pancreatic cancer that cannot be removed surgically
PURPOSE Phase II trial to study the effectiveness of gemcitabine plus radiation therapy in treating patients with pancreatic cancer that cannot be removed surgically
Detailed Description:
OBJECTIVES I Estimate time to progression and overall survival of patients with locoregional adenocarcinoma of the pancreas treated with gemcitabine combined with radiation therapy II Estimate the biomarker response to this regimen through evaluation of circulating CA19-9 levels and correlate this response with survival of this patient population
OUTLINE Patients receive radiation therapy 5 days per week for 5 12 weeks and gemcitabine IV over 30 minutes not greater than 2 hours prior to radiation therapy twice weekly This combination radiation therapy and chemotherapy is followed by 2 weeks of rest Patients with stable or responding disease receive a higher dose of gemcitabine IV over 30 minutes weekly for 3 weeks followed by 1 week of rest This 4 week course is repeated 3 more times for a total of 16 weeks of gemcitabine therapy alone Patients are followed every 2 months for the first year and then every 3 months for the next 2 years or until disease progression Upon documentation of disease progression patients are followed every 3 months for survival and secondary malignancy
PROJECTED ACCRUAL A total of 40 patients will be accrued for this study within 24 months
OUTLINE Patients receive radiation therapy 5 days per week for 5 12 weeks and gemcitabine IV over 30 minutes not greater than 2 hours prior to radiation therapy twice weekly This combination radiation therapy and chemotherapy is followed by 2 weeks of rest Patients with stable or responding disease receive a higher dose of gemcitabine IV over 30 minutes weekly for 3 weeks followed by 1 week of rest This 4 week course is repeated 3 more times for a total of 16 weeks of gemcitabine therapy alone Patients are followed every 2 months for the first year and then every 3 months for the next 2 years or until disease progression Upon documentation of disease progression patients are followed every 3 months for survival and secondary malignancy
PROJECTED ACCRUAL A total of 40 patients will be accrued for this study within 24 months
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 |
|---|---|---|---|
| CDR0000066601 | REGISTRY | NCI Physician Data Query | httpsreporternihgovquickSearchU10CA031946 |
| U10CA031946 | NIH | None | None |
| CLB-89805 | None | None | None |