Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00064207
Status:
COMPLETED
Last Update Posted:
2012-09-24
First Post:
2003-07-08
Brief Title:
Gemcitabine and Radiation Therapy Compared With Gemcitabine Alone in Treating Patients Who Have Undergone Surgery for Pancreatic Cancer
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
Randomized Phase IIIII Study Comparing Gemcitabine Followed by Gemcitabine Plus Concomitant Radiation 504 Gy Versus Control After Curative Pancreaticoduodenectomy for Pancreatic Head Cancer
Status:
COMPLETED
Status Verified Date:
2012-09
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 gemcitabine use different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Radiation therapy uses high-energy x-rays to kill tumor cells Giving these treatments after surgery may kill any tumor cells that remain after surgery It is not yet known whether giving gemcitabine together with radiation therapy is more effective than gemcitabine alone following surgery in treating pancreatic cancer
PURPOSE This randomized phase IIIII trial is studying how well giving gemcitabine together with radiation therapy works and compares it to gemcitabine alone in treating patients who have undergone surgery for pancreatic cancer
PURPOSE This randomized phase IIIII trial is studying how well giving gemcitabine together with radiation therapy works and compares it to gemcitabine alone in treating patients who have undergone surgery for pancreatic cancer
Detailed Description:
OBJECTIVES
Phase II
Determine the feasibility of gemcitabine followed by chemoradiotherapy with gemcitabine vs gemcitabine alone after prior curative resection in patients with pancreatic head adenocarcinoma
Compare the tolerability of these regimens in terms of acute and late toxicity in these patients
Phase III
Compare the disease-free and overall survival of patients treated with these regimens
Compare the quality of life of patients treated with these regimens
Compare the toxicity of these regimens in these patients
Determine the sites of recurrence in patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to ECOGWHO performance status 0-1 vs 2 participating center and N stage N0 vs N1 vs NX Patients are randomized to 1 of 2 treatment arms
Arm I Within 8 weeks after prior surgical resection patients receive gemcitabine IV over 30 minutes on days 1 8 and 15 Treatment repeats every 4 weeks for 2 courses
Patients then receive additional gemcitabine IV over 30 minutes on days 57 64 71 78 85 and 92 Beginning on day 57 patients also undergo radiotherapy once daily 5 days a week for 6 weeks Treatment continues in the absence of disease progression or unacceptable toxicity
Arm II Patients receive gemcitabine IV over 30 minutes on days 1 8 and 15 Treatment repeats every 4 weeks for 4 courses
Quality of life QOL is assessed in both arms according to the following schedules
Arm I QOL is assessed at baseline at 3 weeks after the beginning of chemoradiotherapy after the completion of chemoradiotherapy every 3 months for 2 years and then every 6 months for 1 year
Arm II QOL is assessed at baseline at 12 weeks at 16 weeks every 3 months for 2 years and then every 6 months for 1 year
Patients are followed every 3 months for 2 years and then every 6 months thereafter
PROJECTED ACCRUAL A total of 538 patients 269 per treatment arm will be accrued for this study within 3 years
Phase II
Determine the feasibility of gemcitabine followed by chemoradiotherapy with gemcitabine vs gemcitabine alone after prior curative resection in patients with pancreatic head adenocarcinoma
Compare the tolerability of these regimens in terms of acute and late toxicity in these patients
Phase III
Compare the disease-free and overall survival of patients treated with these regimens
Compare the quality of life of patients treated with these regimens
Compare the toxicity of these regimens in these patients
Determine the sites of recurrence in patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to ECOGWHO performance status 0-1 vs 2 participating center and N stage N0 vs N1 vs NX Patients are randomized to 1 of 2 treatment arms
Arm I Within 8 weeks after prior surgical resection patients receive gemcitabine IV over 30 minutes on days 1 8 and 15 Treatment repeats every 4 weeks for 2 courses
Patients then receive additional gemcitabine IV over 30 minutes on days 57 64 71 78 85 and 92 Beginning on day 57 patients also undergo radiotherapy once daily 5 days a week for 6 weeks Treatment continues in the absence of disease progression or unacceptable toxicity
Arm II Patients receive gemcitabine IV over 30 minutes on days 1 8 and 15 Treatment repeats every 4 weeks for 4 courses
Quality of life QOL is assessed in both arms according to the following schedules
Arm I QOL is assessed at baseline at 3 weeks after the beginning of chemoradiotherapy after the completion of chemoradiotherapy every 3 months for 2 years and then every 6 months for 1 year
Arm II QOL is assessed at baseline at 12 weeks at 16 weeks every 3 months for 2 years and then every 6 months for 1 year
Patients are followed every 3 months for 2 years and then every 6 months thereafter
PROJECTED ACCRUAL A total of 538 patients 269 per treatment arm will be accrued for this study within 3 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 |
|---|---|---|---|
| EU-20540 | None | None | None |
| EORTC-40013 | None | None | None |
| EORTC-22012 | None | None | None |
| FFCD-0304 | None | None | None |