Ignite Creation Date:
2024-05-05 @ 11:37 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00096070
Status:
COMPLETED
Last Update Posted:
2013-07-16
First Post:
2004-11-09
Brief Title:
Radiotherapy Combined With Oxaliplatin and Fluorouracil Followed By Gemcitabine in Treating Patients With Locally Advanced Unresectable Pancreatic Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Study of Oxaliplatin Continuous 5-Fluorouracil and External Beam Radiation Followed by Gemcitabine in Patients With Locally Advanced Pancreatic Cancer
Status:
COMPLETED
Status Verified Date:
2013-06
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:
This phase II trial is studying how well giving radiation therapy together with oxaliplatin and fluorouracil followed by gemcitabine works in treating patients with locally advanced unresectable pancreatic cancer Radiation therapy uses high-energy x-rays to damage tumor cells Drugs used in chemotherapy such as oxaliplatin fluorouracil and gemcitabine work in different ways to stop tumor cells from dividing so they stop growing or die Oxaliplatin may also make the tumor cells more sensitive to radiation therapy Giving radiation therapy with chemotherapy may kill more tumor cells
Detailed Description:
PRIMARY OBJECTIVES
I Determine the 1-year survival rate in patients with locally advanced unresectable adenocarcinoma of the pancreas treated with concurrent external beam radiotherapy oxaliplatin and fluorouracil followed by gemcitabine
SECONDARY OBJECTIVES
I Determine overall survival time to disease progression and confirmed response rate in patients treated with this regimen
II Determine toxicity of this regimen in these patients
OUTLINE This is a multicenter study
Patients undergo radiotherapy once daily 5 days a week for 55 weeks Beginning concurrently with radiotherapy patients receive oxaliplatin IV over 2 hours on days 1 15 and 29 and fluorouracil IV continuously for 55 weeks Beginning 4-6 weeks after the completion of chemoradiotherapy patients receive gemcitabine IV over 30 minutes on days 1 and 8 Treatment with gemcitabine repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 2 years and then every 6 months for 1 year
I Determine the 1-year survival rate in patients with locally advanced unresectable adenocarcinoma of the pancreas treated with concurrent external beam radiotherapy oxaliplatin and fluorouracil followed by gemcitabine
SECONDARY OBJECTIVES
I Determine overall survival time to disease progression and confirmed response rate in patients treated with this regimen
II Determine toxicity of this regimen in these patients
OUTLINE This is a multicenter study
Patients undergo radiotherapy once daily 5 days a week for 55 weeks Beginning concurrently with radiotherapy patients receive oxaliplatin IV over 2 hours on days 1 15 and 29 and fluorouracil IV continuously for 55 weeks Beginning 4-6 weeks after the completion of chemoradiotherapy patients receive gemcitabine IV over 30 minutes on days 1 and 8 Treatment with gemcitabine repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 2 years and then every 6 months for 1 year
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 |
|---|---|---|---|
| U10CA025224 | NIH | None | httpsreporternihgovquickSearchU10CA025224 |
| N0349 | None | None | None |
| CDR0000391191 | None | None | None |
| NCCTG-N0349 | None | None | None |