Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003216
Status:
COMPLETED
Last Update Posted:
2013-11-19
First Post:
1999-11-01
Brief Title:
Fluorouracil Gemcitabine and Radiation Therapy in Treating Patients With Cancer of the Pancreas
Sponsor:
Radiation Therapy Oncology Group
Organization:
Radiation Therapy Oncology Group
Study Overview
Official Title:
A Phase III Study of Pre and Post Chemoradiation 5-FU vs Pre and Post Chemoradiation Gemcitabine for Postoperative Adjuvant Treatment of Resected Pancreatic Adenocarcinoma
Status:
COMPLETED
Status Verified Date:
2013-11
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 radiation therapy with chemotherapy may kill more tumor cells It is not yet known which treatment regimen is most effective for pancreatic cancer
PURPOSE Randomized phase III trial to compare the effectiveness of fluorouracil and gemcitabine plus radiation therapy in treating patients with cancer of the pancreas who have undergone surgery
PURPOSE Randomized phase III trial to compare the effectiveness of fluorouracil and gemcitabine plus radiation therapy in treating patients with cancer of the pancreas who have undergone surgery
Detailed Description:
OBJECTIVES
Compare the overall and disease-free survival of patients with resected adenocarcinoma of the pancreas treated with adjuvant fluorouracil-based chemoradiotherapy preceded and followed by fluorouracil vs gemcitabine
Compare the local-regional and distant disease control in patients treated with these regimens
Compare the acute and late toxic effects of these regimens in these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to nodal involvement yes vs no tumor diameter less than 3 cm vs 3 cm or greater and surgical margins negative vs positive vs unknown Patients are randomized to one of two treatment arms
Arm I Beginning 3-8 weeks after definitive surgical resection patients receive fluorouracil IV continuously for 3 weeks Beginning 1-2 weeks later patients receive fluorouracil IV continuously concurrently with radiotherapy 5 days a week for 55 weeks Beginning 3-5 weeks after completion of chemoradiotherapy patients receive fluorouracil IV continuously for 4 weeks every 6 weeks for 2 courses
Arm II Beginning 3-8 weeks after definitive surgical resection patients receive gemcitabine IV once weekly for 3 weeks Beginning 1-2 weeks later patients receive chemoradiotherapy as in arm I Beginning 3-5 weeks after completion of chemoradiotherapy patients receive gemcitabine IV once weekly for 3 weeks every 4 weeks for 3 courses
Patients are followed every 3 months for 1 year every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 518 patients will be accrued for this study within 86 years
Compare the overall and disease-free survival of patients with resected adenocarcinoma of the pancreas treated with adjuvant fluorouracil-based chemoradiotherapy preceded and followed by fluorouracil vs gemcitabine
Compare the local-regional and distant disease control in patients treated with these regimens
Compare the acute and late toxic effects of these regimens in these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to nodal involvement yes vs no tumor diameter less than 3 cm vs 3 cm or greater and surgical margins negative vs positive vs unknown Patients are randomized to one of two treatment arms
Arm I Beginning 3-8 weeks after definitive surgical resection patients receive fluorouracil IV continuously for 3 weeks Beginning 1-2 weeks later patients receive fluorouracil IV continuously concurrently with radiotherapy 5 days a week for 55 weeks Beginning 3-5 weeks after completion of chemoradiotherapy patients receive fluorouracil IV continuously for 4 weeks every 6 weeks for 2 courses
Arm II Beginning 3-8 weeks after definitive surgical resection patients receive gemcitabine IV once weekly for 3 weeks Beginning 1-2 weeks later patients receive chemoradiotherapy as in arm I Beginning 3-5 weeks after completion of chemoradiotherapy patients receive gemcitabine IV once weekly for 3 weeks every 4 weeks for 3 courses
Patients are followed every 3 months for 1 year every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 518 patients will be accrued for this study within 86 years
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 |
|---|---|---|---|
| SWOG-R9704 | None | None | None |
| CDR0000066076 | None | None | None |
| E-R9704 | None | None | None |