Ignite Creation Date:
2024-05-05 @ 5:14 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00416507
Status:
COMPLETED
Last Update Posted:
2016-05-30
First Post:
2006-12-27
Brief Title:
Gemcitabine With or Without Combination Chemotherapy and Radiation Therapy in Treating Patients With Nonmetastatic Pancreatic Cancer That Cannot Be Removed By Surgery
Sponsor:
Federation Francophone de Cancerologie Digestive
Organization:
Federation Francophone de Cancerologie Digestive
Study Overview
Official Title:
Non Resectable But Non Metastatic Adenocarcinoma of the Exocrine Pancreas Non Resecables Randomised Phase III Initial Radiochimiotherapy 5-FU Cisplatine 60 GY Radiotherapy Followed by Gemcitabine Versus Gemcitabine Alone
Status:
COMPLETED
Status Verified Date:
2016-05
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 such as gemcitabine fluorouracil and cisplatin 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 more than one drug combination chemotherapy together with radiation therapy may kill more tumor cells It is not yet known which treatment regimen is more effective for pancreatic cancer
PURPOSE This randomized phase III trial is studying gemcitabine fluorouracil cisplatin and radiation therapy to see how well they work compared to gemcitabine alone in treating patients with nonmetastatic pancreatic cancer that cannot be removed by surgery
PURPOSE This randomized phase III trial is studying gemcitabine fluorouracil cisplatin and radiation therapy to see how well they work compared to gemcitabine alone in treating patients with nonmetastatic pancreatic cancer that cannot be removed by surgery
Detailed Description:
OBJECTIVES
Primary
Compare the overall survival of patients with nonresectable nonmetastatic adenocarcinoma of the pancreas treated with gemcitabine hydrochloride with vs without fluorouracil cisplatin and radiotherapy followed by gemcitabine hydrochloride
Secondary
Compare the toxicities of these regimens in these patients
Compare the objective response complete partial or stable in patients treated with these regimens
Compare the clinical benefit in terms of general condition and weight maintenance in patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to WHO performance status 0 or 1 vs 2 initial treatment laparotomy with or without bilio-digestive diversion yes vs no and peritoneal cytology positive vs negative Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive cisplatin IV over 15 minutes on days 1-5 and 29-33 and fluorouracil IV continuously on days 1-40 Patients also undergo radiotherapy daily 5 days a week for 6 weeks
Arm II Patients receive gemcitabine hydrochloride IV over 15 minutes on day 1 Treatment repeats every 7 days for 7 weeks
Beginning in week 11 of arm I or week 9 of arm II patients receive gemcitabine hydrochloride IV over 15 minutes on days 1 8 and 15 Treatment repeats every 4 weeks for up to 10 courses in the absence of disease progression or unacceptable toxicity
After completion of study therapy patients are followed periodically
PROJECTED ACCRUAL A total of 190 patients will be accrued for this trial
Primary
Compare the overall survival of patients with nonresectable nonmetastatic adenocarcinoma of the pancreas treated with gemcitabine hydrochloride with vs without fluorouracil cisplatin and radiotherapy followed by gemcitabine hydrochloride
Secondary
Compare the toxicities of these regimens in these patients
Compare the objective response complete partial or stable in patients treated with these regimens
Compare the clinical benefit in terms of general condition and weight maintenance in patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to WHO performance status 0 or 1 vs 2 initial treatment laparotomy with or without bilio-digestive diversion yes vs no and peritoneal cytology positive vs negative Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive cisplatin IV over 15 minutes on days 1-5 and 29-33 and fluorouracil IV continuously on days 1-40 Patients also undergo radiotherapy daily 5 days a week for 6 weeks
Arm II Patients receive gemcitabine hydrochloride IV over 15 minutes on day 1 Treatment repeats every 7 days for 7 weeks
Beginning in week 11 of arm I or week 9 of arm II patients receive gemcitabine hydrochloride IV over 15 minutes on days 1 8 and 15 Treatment repeats every 4 weeks for up to 10 courses in the absence of disease progression or unacceptable toxicity
After completion of study therapy patients are followed periodically
PROJECTED ACCRUAL A total of 190 patients will be accrued for this trial
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 |
|---|---|---|---|
| FFCD-SFRO-2000-01 | None | None | None |
| FFCD-2000-01 | None | None | None |
| EU-20542 | None | None | None |