Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00068575
Status:
COMPLETED
Last Update Posted:
2012-02-15
First Post:
2003-09-10
Brief Title:
Chemotherapy Interferon Alfa and Radiation Therapy in Treating Patients Who Have Undergone Surgery For Pancreatic Cancer
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
A Phase II Trial of Pancreaticoduodenectomy Plus Postoperative Cisplatin Interferon Alfa-2b and 5-FU Combined With Radiation Treatment for Patients With Resected Pancreatic Adenocarcinoma
Status:
COMPLETED
Status Verified Date:
2012-02
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 cisplatin and fluorouracil use different ways to stop tumor cells from dividing so they stop growing or die Biological therapies such as interferon alfa may interfere with the growth of the tumor cells and slow the growth of cancer Radiation therapy uses high-energy x-rays to damage tumor cells Combining chemotherapy and interferon alfa with radiation therapy after surgery may kill any remaining tumor cells
PURPOSE This phase II trial is studying how well giving cisplatin fluorouracil and interferon alfa together with radiation therapy works in treating patients who have undergone surgery for stage I stage II or stage III pancreatic cancer
PURPOSE This phase II trial is studying how well giving cisplatin fluorouracil and interferon alfa together with radiation therapy works in treating patients who have undergone surgery for stage I stage II or stage III pancreatic cancer
Detailed Description:
OBJECTIVES
Primary
Determine the overall survival of patients with previously resected pancreatic adenocarcinoma treated with postoperative cisplatin interferon alfa fluorouracil and concurrent radiotherapy
Determine the toxic effects of this regimen in these patients
Secondary
Determine the disease-specific biochemical failure-free and symptomtreatment-free survival of patients treated with this regimen
Determine the quality of life of patients treated with this regimen
OUTLINE
Chemoradiotherapy Patients receive fluorouracil intravenous IV continuously and interferon alfa subcutaneously SQ 3 times per week total of 17 doses on days 1-19 and 29-45 and cisplatin IV over 6 hours on days 1 8 15 29 36 and 43 Patients also undergo concurrent radiotherapy once daily 5 days a week in weeks 1-3 and 5-7 28 fractions
Post-chemoradiotherapy fluorouracil Patients receive fluorouracil IV continuously on days 71-108 and 127-168
PROJECTED ACCRUAL A total of 44 patients will be accrued for this study
Primary
Determine the overall survival of patients with previously resected pancreatic adenocarcinoma treated with postoperative cisplatin interferon alfa fluorouracil and concurrent radiotherapy
Determine the toxic effects of this regimen in these patients
Secondary
Determine the disease-specific biochemical failure-free and symptomtreatment-free survival of patients treated with this regimen
Determine the quality of life of patients treated with this regimen
OUTLINE
Chemoradiotherapy Patients receive fluorouracil intravenous IV continuously and interferon alfa subcutaneously SQ 3 times per week total of 17 doses on days 1-19 and 29-45 and cisplatin IV over 6 hours on days 1 8 15 29 36 and 43 Patients also undergo concurrent radiotherapy once daily 5 days a week in weeks 1-3 and 5-7 28 fractions
Post-chemoradiotherapy fluorouracil Patients receive fluorouracil IV continuously on days 71-108 and 127-168
PROJECTED ACCRUAL A total of 44 patients will be 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 |
|---|---|---|---|
| CDR0000327752 | REGISTRY | NCI PDQ | httpsreporternihgovquickSearchP30CA016672 |
| P30CA016672 | NIH | None | None |
| MDA-ID-02040 | OTHER | None | None |