Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00057876
Status:
COMPLETED
Last Update Posted:
2023-07-05
First Post:
2003-04-07
Brief Title:
Gemcitabine With or Without Radiation Therapy in Treating Patients With Pancreatic Cancer
Sponsor:
Eastern Cooperative Oncology Group
Organization:
Eastern Cooperative Oncology Group
Study Overview
Official Title:
A Randomized Phase III Study Of Gemcitabine In Combination With Radiation Therapy Versus Gemcitabine Alone In Patients With Localized Unresectable Pancreatic Cancer
Status:
COMPLETED
Status Verified Date:
2023-06
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 work in 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 It is not yet known whether gemcitabine is more effective with or without radiation therapy in treating pancreatic cancer
PURPOSE Randomized phase III trial to study the effectiveness of gemcitabine with or without radiation therapy in treating patients who have locally advanced unresectable pancreatic cancer
PURPOSE Randomized phase III trial to study the effectiveness of gemcitabine with or without radiation therapy in treating patients who have locally advanced unresectable pancreatic cancer
Detailed Description:
OBJECTIVES
Compare the overall survival and progression-free of patients with locally advanced unresectable pancreatic cancer treated with gemcitabine with or without radiotherapy
Compare the objective response rate in patients treated with these regimens
Compare the toxicity of these regimens in these patients
Compare the quality of life QOL of patients treated with these regimens
Determine the effect of gemcitabine and radiotherapy on the QOL of patients with improved objective response rate and progression-free and overall survival
OUTLINE This is a randomized multicenter study Patients are stratified according to performance status 0 vs 1 and weight loss within the past 6 months less than 10 vs 10 or more Patients are randomized to 1 of 2 treatment arms
Arm I Gemcitabine alone
Induction Patients receive gemcitabine intravenously IV over 30-60 minutes once weekly for 6 weeks followed by 1 week of rest
Consolidation After the 1 week of rest patients receive gemcitabine IV once weekly for 3 weeks Treatment repeats every 4 weeks for 5 courses in the absence of disease progression or unacceptable toxicity
Arm II Gemcitabine with radiotherapy
Induction Patients receive gemcitabine IV over 30-60 minutes once weekly for 6 weeks beginning on day 1 Patients also undergo concurrent radiotherapy 5 days a week for 55 weeks beginning on day 1
Consolidation Approximately 4 weeks after completion of radiotherapy patients receive gemcitabine IV over 30-60 minutes once weekly for 3 weeks Treatment repeats every 4 weeks for 5 courses in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline week 6 week 15 for arm II week 16 for arm I and 9 months
Patients are followed every 3 months for 2 years and then every 6 months for 1 year Patients who receive treatment beyond 3 years are followed for survival
ACCRUAL 74 patients were accrued for this study
Compare the overall survival and progression-free of patients with locally advanced unresectable pancreatic cancer treated with gemcitabine with or without radiotherapy
Compare the objective response rate in patients treated with these regimens
Compare the toxicity of these regimens in these patients
Compare the quality of life QOL of patients treated with these regimens
Determine the effect of gemcitabine and radiotherapy on the QOL of patients with improved objective response rate and progression-free and overall survival
OUTLINE This is a randomized multicenter study Patients are stratified according to performance status 0 vs 1 and weight loss within the past 6 months less than 10 vs 10 or more Patients are randomized to 1 of 2 treatment arms
Arm I Gemcitabine alone
Induction Patients receive gemcitabine intravenously IV over 30-60 minutes once weekly for 6 weeks followed by 1 week of rest
Consolidation After the 1 week of rest patients receive gemcitabine IV once weekly for 3 weeks Treatment repeats every 4 weeks for 5 courses in the absence of disease progression or unacceptable toxicity
Arm II Gemcitabine with radiotherapy
Induction Patients receive gemcitabine IV over 30-60 minutes once weekly for 6 weeks beginning on day 1 Patients also undergo concurrent radiotherapy 5 days a week for 55 weeks beginning on day 1
Consolidation Approximately 4 weeks after completion of radiotherapy patients receive gemcitabine IV over 30-60 minutes once weekly for 3 weeks Treatment repeats every 4 weeks for 5 courses in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline week 6 week 15 for arm II week 16 for arm I and 9 months
Patients are followed every 3 months for 2 years and then every 6 months for 1 year Patients who receive treatment beyond 3 years are followed for survival
ACCRUAL 74 patients were accrued for this study
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 |
|---|---|---|---|
| U10CA021115 | NIH | None | None |
| E4201 | OTHER | Eastern Cooperative Oncology Group ECOG and Radiation Therapy Oncology Group RTOG | httpsreporternihgovquickSearchU10CA021115 |