Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00059826
Status:
COMPLETED
Last Update Posted:
2016-12-07
First Post:
2003-05-06
Brief Title:
Adjuvant Chemoradiotherapy and Interferon Alfa in Treating Patients With Resected Pancreatic Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
A Phase II Study of Interferon-Based Adjuvant Chemoradiation in Patients With Resected Pancreatic Adenocarcinoma
Status:
COMPLETED
Status Verified Date:
2016-12
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 fluorouracil and cisplatin work in different ways to stop tumor cells from dividing so they stop growing or die Interferon alfa may interfere with the growth of tumor cells Radiation therapy uses high-energy radiation from x-rays and other sources to kill tumor cells Combining chemotherapy with interferon alfa and giving them with radiation therapy after surgery may kill any remaining tumor cells
PURPOSE Phase II trial to study the effectiveness of adjuvant chemoradiotherapy and interferon alfa in treating patients who have resected stage I stage II or stage III pancreatic cancer
PURPOSE Phase II trial to study the effectiveness of adjuvant chemoradiotherapy and interferon alfa in treating patients who have resected stage I stage II or stage III pancreatic cancer
Detailed Description:
OBJECTIVES
Determine the disease-free and overall survival of patients with resected pancreatic adenocarcinoma treated with adjuvant chemoradiotherapy comprising fluorouracil cisplatin and interferon alfa
Determine the rate and severity of acute and late toxic effects in patients treated with this regimen
Determine the local-regional disease control and distant disease control in patients treated with this regimen
OUTLINE This is a multicenter study
Chemoradiotherapy CRT Patients receive fluorouracil IV continuously 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
Post-CRT chemotherapy Beginning 4-6 weeks after the completion of CRT patients receive fluorouracil IV continuously on days 1-42 Treatment repeats every 56 days for a total of two courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 2 months for 2 years every 3 months for 1 year every 4 months for 1 year every 6 months for 1 year and then annually thereafter
Determine the disease-free and overall survival of patients with resected pancreatic adenocarcinoma treated with adjuvant chemoradiotherapy comprising fluorouracil cisplatin and interferon alfa
Determine the rate and severity of acute and late toxic effects in patients treated with this regimen
Determine the local-regional disease control and distant disease control in patients treated with this regimen
OUTLINE This is a multicenter study
Chemoradiotherapy CRT Patients receive fluorouracil IV continuously 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
Post-CRT chemotherapy Beginning 4-6 weeks after the completion of CRT patients receive fluorouracil IV continuously on days 1-42 Treatment repeats every 56 days for a total of two courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 2 months for 2 years every 3 months for 1 year every 4 months for 1 year every 6 months for 1 year 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 |
|---|---|---|---|
| CDR0000298776 | REGISTRY | NCI Physician Data Query | None |