Ignite Creation Date:
2024-05-05 @ 4:35 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00275119
Status:
UNKNOWN
Last Update Posted:
2009-02-09
First Post:
2006-01-10
Brief Title:
Gemcitabine and Oxaliplatin Followed By Radiation Therapy Fluorouracil and Oxaliplatin in Treating Patients With Locally Advanced Pancreatic Cancer That Cannot Be Removed By Surgery
Sponsor:
GERCOR - Multidisciplinary Oncology Cooperative Group
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Protocole de Phase II Etude de Faisabilite de LOxaliplatine en Association Chimio-Radiotherapie Concomitante Dans le Traitement Des Cancers du Pancreas Localement Avances Non Resecables
Status:
UNKNOWN
Status Verified Date:
2006-01
Last Known Status:
ACTIVE_NOT_RECRUITING
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 such as gemcitabine oxaliplatin and fluorouracil work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Radiation therapy uses high-energy x-rays to kill tumor cells Giving chemotherapy together with radiation therapy may kill more tumor cells
PURPOSE This phase II trial is studying how well giving gemcitabine together with oxaliplatin followed by radiation therapy fluorouracil and oxaliplatin works in treating patients with locally advanced pancreatic cancer that cannot be removed by surgery
PURPOSE This phase II trial is studying how well giving gemcitabine together with oxaliplatin followed by radiation therapy fluorouracil and oxaliplatin works in treating patients with locally advanced pancreatic cancer that cannot be removed by surgery
Detailed Description:
OBJECTIVES
Primary
Compare progression-free survival of patients with locally advanced nonresectable adenocarcinoma of the pancreas treated with gemcitabine hydrochloride and oxaliplatin followed by concurrent radiotherapy fluorouracil and oxaliplatin
Secondary
Determine the tolerability of this regimen in both the short- and long-term in these patients
Determine recurrence-free survival overall survival and response rate in patients treated with this regimen
Determine the quality of life of patients treated with this regimen
Determine the clinical benefits of this regimen in these patients
Determine locoregional and metastatic progression-free survival of patients treated with this regimen
OUTLINE This is an open-label multicenter study
Chemotherapy Patients receive gemcitabine hydrochloride over 100 minutes on day 1 and oxaliplatin IV over 2 hours on day 2 Treatment repeats every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity Patients are restaged at day 15-21 of the fourth course of chemotherapy Patients with nonmetastatic disease proceed to chemoradiotherapy
Chemoradiotherapy Patients undergo radiotherapy 5 days a week for 5 weeks Patients also receive fluorouracil IV continuously in weeks 1-5 and oxaliplatin IV over 1 hour on days 1 8 15 22 and 29 in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline at restaging and at day 28 after completion of chemoradiotherapy
After completion of study treatment patients are followed periodically for 5 years
PROJECTED ACCRUAL A total of 58 patients will be accrued for this study
Primary
Compare progression-free survival of patients with locally advanced nonresectable adenocarcinoma of the pancreas treated with gemcitabine hydrochloride and oxaliplatin followed by concurrent radiotherapy fluorouracil and oxaliplatin
Secondary
Determine the tolerability of this regimen in both the short- and long-term in these patients
Determine recurrence-free survival overall survival and response rate in patients treated with this regimen
Determine the quality of life of patients treated with this regimen
Determine the clinical benefits of this regimen in these patients
Determine locoregional and metastatic progression-free survival of patients treated with this regimen
OUTLINE This is an open-label multicenter study
Chemotherapy Patients receive gemcitabine hydrochloride over 100 minutes on day 1 and oxaliplatin IV over 2 hours on day 2 Treatment repeats every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity Patients are restaged at day 15-21 of the fourth course of chemotherapy Patients with nonmetastatic disease proceed to chemoradiotherapy
Chemoradiotherapy Patients undergo radiotherapy 5 days a week for 5 weeks Patients also receive fluorouracil IV continuously in weeks 1-5 and oxaliplatin IV over 1 hour on days 1 8 15 22 and 29 in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline at restaging and at day 28 after completion of chemoradiotherapy
After completion of study treatment patients are followed periodically for 5 years
PROJECTED ACCRUAL A total of 58 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| SANOFI-GERCOR-D03-1 | None | None | None |
| GERCOR-D03-1 | None | None | None |
| EU-20570 | None | None | None |