Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00262951
Status:
TERMINATED
Last Update Posted:
2017-12-28
First Post:
2005-12-06
Brief Title:
Chemoradiation in Locally Advanced Pancreatic Cancer
Sponsor:
Masonic Cancer Center University of Minnesota
Organization:
Masonic Cancer Center University of Minnesota
Study Overview
Official Title:
A Phase II Pilot Study of Multi-Agent Neo-Adjuvant Chemoradiation in Patients With Locally Advanced Pancreatic Adenocarcinoma
Status:
TERMINATED
Status Verified Date:
2017-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Closed at a planned interim analysis by meeting a predefined toxicity endpoint
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 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 Giving more than one drug combination chemotherapy may kill more tumor cells Radiation therapy uses high-energy x-rays to kill tumor cells Interferon alfa may interfere with the growth of tumor cells Giving combination chemotherapy and radiation therapy together with interferon alfa before surgery may shrink the tumor so it can be removed Giving chemotherapy after surgery may kill any tumor cells that remain after surgery
PURPOSE This phase II trial is studying how well giving combination chemotherapy and radiation therapy together with interferon alfa 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 combination chemotherapy and radiation therapy together with interferon alfa works in treating patients with locally advanced pancreatic cancer that cannot be removed by surgery
Detailed Description:
OBJECTIVES
Primary
Determine the effect of neoadjuvant chemoradiotherapy and interferon alfa on converting patients with locally advanced unresectable adenocarcinoma of the pancreas to resectability
Secondary
Determine the rate and severity of early and late toxic effects of these regimens in these patients
Improve surgical morbidity profile and overall survival of patients who undergo surgical resection
Determine overall and progression-free survival of patients treated with this regimen
OUTLINE This is an pilot single center study
Part 1 neoadjuvant therapy Patients receive fluorouracil IV continuously over 24 hours on days 1-38 cisplatin IV over 1 hour on days 1 8 15 22 29 and 36 and interferon alfa subcutaneously on days 1 3 5 8 10 12 15 17 19 22 24 26 29 31 33 36 and 38 Patients also undergo radiotherapy on days 1-5 8-12 15-19 22-26 29-33 and 36-38 Patients then undergo restaging Patients with resectable disease undergo surgery and 4-10 weeks later proceed to part 2 Patients with unresectable disease proceed directly to part 2 4 weeks after completion of neoadjuvant therapy
Part 2 chemotherapy Patients receive fluorouracil IV on days 1 8 15 22 29 and 36 Treatment repeats every 56 days for up to 2 courses in the absence of disease progression or unacceptable toxicity Patients with unresectable disease undergo restaging after each course of fluorouracil If the tumor subsequently becomes resectable patients then undergo surgery
After completion of study treatment patients are followed periodically for 5 years and then annually thereafter
Primary
Determine the effect of neoadjuvant chemoradiotherapy and interferon alfa on converting patients with locally advanced unresectable adenocarcinoma of the pancreas to resectability
Secondary
Determine the rate and severity of early and late toxic effects of these regimens in these patients
Improve surgical morbidity profile and overall survival of patients who undergo surgical resection
Determine overall and progression-free survival of patients treated with this regimen
OUTLINE This is an pilot single center study
Part 1 neoadjuvant therapy Patients receive fluorouracil IV continuously over 24 hours on days 1-38 cisplatin IV over 1 hour on days 1 8 15 22 29 and 36 and interferon alfa subcutaneously on days 1 3 5 8 10 12 15 17 19 22 24 26 29 31 33 36 and 38 Patients also undergo radiotherapy on days 1-5 8-12 15-19 22-26 29-33 and 36-38 Patients then undergo restaging Patients with resectable disease undergo surgery and 4-10 weeks later proceed to part 2 Patients with unresectable disease proceed directly to part 2 4 weeks after completion of neoadjuvant therapy
Part 2 chemotherapy Patients receive fluorouracil IV on days 1 8 15 22 29 and 36 Treatment repeats every 56 days for up to 2 courses in the absence of disease progression or unacceptable toxicity Patients with unresectable disease undergo restaging after each course of fluorouracil If the tumor subsequently becomes resectable patients then undergo surgery
After completion of study treatment patients are followed periodically for 5 years and then annually thereafter
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 |
|---|---|---|---|
| 0410M64346 | OTHER | IRB University of Minnesota | None |