Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00049348
Status:
COMPLETED
Last Update Posted:
2023-06-15
First Post:
2002-11-12
Brief Title:
Chemotherapy and Radiation Therapy in Treating Patients With Locally Advanced Pancreatic Cancer
Sponsor:
Eastern Cooperative Oncology Group
Organization:
Eastern Cooperative Oncology Group
Study Overview
Official Title:
A Randomized Phase II Study Of Gemcitabine Plus Radiotherapy Vs Gemcitabine 5-Fluorouracil And Cisplatin Followed By Radiotherapy And 5-Fluoraracil For Patients With Locally Advanced Potentially Resectable Pancreatic Adenocarcinoma
Status:
COMPLETED
Status Verified Date:
2023-06
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 chemotherapy with radiation therapy before surgery may shrink the tumor so that it can be removed during surgery
PURPOSE Randomized phase II trial to compare the effectiveness of two different regimens combining chemotherapy with radiation therapy in treating patients who are undergoing surgery for locally advanced pancreatic cancer
PURPOSE Randomized phase II trial to compare the effectiveness of two different regimens combining chemotherapy with radiation therapy in treating patients who are undergoing surgery for locally advanced pancreatic cancer
Detailed Description:
OBJECTIVES
Compare the percentage of margin-free resections in patients with locally advanced potentially resectable adenocarcinoma of the pancreas treated with gemcitabine and radiotherapy vs gemcitabine fluorouracil and cisplatin followed by radiotherapy and fluorouracil
Compare the efficacy of these regimens as measured by CT scan response in these patients
Compare the posttreatment fibrosis in resected specimens of patients treated with these regimens
Compare the toxicity of these regimens in these patients
Compare the duration of objective response in patients treated with these regimens
Compare the disease-free and overall survival of patients treated with these regimens
Compare the effect of these regimens and disease recurrence on CA 19-9 values in these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to superior mesenteric vein SMVportal vein PV occlusion yes vs no SMVPVsuperior mesenteric arteryhepatic artery abutment or narrowing yes vs no prior exploration yes vs no and whether deemed to require preoperative therapy due to other factors yes vs no Patients are randomized to 1 of 2 treatment arms
Arm I Patients undergo radiotherapy once daily 5 days a week for 6 weeks Patients receive gemcitabine IV over 50 minutes once weekly for 6 weeks during radiotherapy Patients undergo surgical resection 4-6 weeks after completion of chemoradiotherapy
Maintenance therapy 4-8 weeks after completion of surgery Patients receive gemcitabine IV over 100 minutes once weekly for 2 weeks Treatment repeats every 3 weeks for 5 courses in the absence of disease progression or unacceptable toxicity
Arm II Patients receive gemcitabine IV over 30 minutes on days 1 5 29 and 33 cisplatin IV over 60 minutes on days 1-5 and 29-33 and fluorouracil IV continuously on days 1-4 and 29-32 Patients also receive filgrastim G-CSF subcutaneously SC daily on days 6-15 and 34-43 and epoetin alfa SC weekly on weeks 1-9 After completion of chemotherapy patients undergo radiotherapy once daily 5 days a week for 6 weeks Patients receive fluorouracil IV continuously daily during radiotherapy Patients undergo surgical resection 4-6 weeks after completion of chemoradiotherapy
Maintenance therapy 4-8 weeks after completion of surgery Patients receive gemcitabine IV over 100 minutes once weekly for 2 weeks Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 2 years and then every 6 months for 2 years
PROJECTED ACCRUAL A total of 80-160 patients 40-80 per treatment arm will be accrued for this study
Compare the percentage of margin-free resections in patients with locally advanced potentially resectable adenocarcinoma of the pancreas treated with gemcitabine and radiotherapy vs gemcitabine fluorouracil and cisplatin followed by radiotherapy and fluorouracil
Compare the efficacy of these regimens as measured by CT scan response in these patients
Compare the posttreatment fibrosis in resected specimens of patients treated with these regimens
Compare the toxicity of these regimens in these patients
Compare the duration of objective response in patients treated with these regimens
Compare the disease-free and overall survival of patients treated with these regimens
Compare the effect of these regimens and disease recurrence on CA 19-9 values in these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to superior mesenteric vein SMVportal vein PV occlusion yes vs no SMVPVsuperior mesenteric arteryhepatic artery abutment or narrowing yes vs no prior exploration yes vs no and whether deemed to require preoperative therapy due to other factors yes vs no Patients are randomized to 1 of 2 treatment arms
Arm I Patients undergo radiotherapy once daily 5 days a week for 6 weeks Patients receive gemcitabine IV over 50 minutes once weekly for 6 weeks during radiotherapy Patients undergo surgical resection 4-6 weeks after completion of chemoradiotherapy
Maintenance therapy 4-8 weeks after completion of surgery Patients receive gemcitabine IV over 100 minutes once weekly for 2 weeks Treatment repeats every 3 weeks for 5 courses in the absence of disease progression or unacceptable toxicity
Arm II Patients receive gemcitabine IV over 30 minutes on days 1 5 29 and 33 cisplatin IV over 60 minutes on days 1-5 and 29-33 and fluorouracil IV continuously on days 1-4 and 29-32 Patients also receive filgrastim G-CSF subcutaneously SC daily on days 6-15 and 34-43 and epoetin alfa SC weekly on weeks 1-9 After completion of chemotherapy patients undergo radiotherapy once daily 5 days a week for 6 weeks Patients receive fluorouracil IV continuously daily during radiotherapy Patients undergo surgical resection 4-6 weeks after completion of chemoradiotherapy
Maintenance therapy 4-8 weeks after completion of surgery Patients receive gemcitabine IV over 100 minutes once weekly for 2 weeks Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 2 years and then every 6 months for 2 years
PROJECTED ACCRUAL A total of 80-160 patients 40-80 per treatment arm 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 |
|---|---|---|---|
| E1200 | None | None | None |