Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00026130
Status:
COMPLETED
Last Update Posted:
2016-07-19
First Post:
2001-11-09
Brief Title:
Combination Chemotherapy and 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:
A Phase II Trial of Gemcitabine 5-Fluorouracil and Radiation Therapy in Locally Advanced Non-Metastatic Pancreatic Adenocarcinoma
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 combination chemotherapy and radiation therapy in treating patients who have locally advanced pancreatic cancer
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy and radiation therapy in treating patients who have locally advanced pancreatic cancer
Detailed Description:
OBJECTIVES
Determine the overall survival of patients with locally advanced non-metastatic pancreatic adenocarcinoma treated with gemcitabine fluorouracil and radiotherapy
Determine the time to progression in patients treated with this regimen
Determine the overall clinical response in patients treated with this regimen
Determine the toxicity of this regimen in these patients
OUTLINE This is a multicenter study
Patients receive gemcitabine IV over 30 minutes once weekly and fluorouracil IV continuously on days 1-5 weekly for 6 weeks Patients concurrently undergo radiotherapy 5 days a week for 6 weeks
Three weeks after the completion of chemoradiotherapy patients receive gemcitabine IV over 30 minutes once weekly on weeks 1-3 Treatment repeats every 4 weeks for a total of 4 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 2 months for 1 year and then every 3 months for 2 years
PROJECTED ACCRUAL A total of 78 patients will be accrued for this study within 24 months
Determine the overall survival of patients with locally advanced non-metastatic pancreatic adenocarcinoma treated with gemcitabine fluorouracil and radiotherapy
Determine the time to progression in patients treated with this regimen
Determine the overall clinical response in patients treated with this regimen
Determine the toxicity of this regimen in these patients
OUTLINE This is a multicenter study
Patients receive gemcitabine IV over 30 minutes once weekly and fluorouracil IV continuously on days 1-5 weekly for 6 weeks Patients concurrently undergo radiotherapy 5 days a week for 6 weeks
Three weeks after the completion of chemoradiotherapy patients receive gemcitabine IV over 30 minutes once weekly on weeks 1-3 Treatment repeats every 4 weeks for a total of 4 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 2 months for 1 year and then every 3 months for 2 years
PROJECTED ACCRUAL A total of 78 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 |
|---|---|---|---|
| CDR0000068988 | REGISTRY | NCI Physician Data Query | httpsreporternihgovquickSearchU10CA031946 |
| U10CA031946 | NIH | None | None |
| CALGB-80003 | None | None | None |