Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00026403
Status:
COMPLETED
Last Update Posted:
2016-07-14
First Post:
2001-11-09
Brief Title:
Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Advanced 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 Gemcitabine Cisplatin and Radiation Therapy in Patients With Locally Advanced Pancreatic Cancer
Status:
COMPLETED
Status Verified Date:
2016-07
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 Combining radiation therapy with chemotherapy may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating patients who have locally advanced pancreatic cancer
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating patients who have locally advanced pancreatic cancer
Detailed Description:
OBJECTIVES
Determine the efficacy of gemcitabine cisplatin and radiotherapy in terms of 1-year survival in patients with locally advanced pancreatic cancer
Determine the toxicity of this regimen in these patients
Determine the quality of life of patients treated with this regimen
OUTLINE This is a multicenter study
Patients undergo radiotherapy once daily five days a week for 55 weeks Patients receive gemcitabine IV over 30 minutes followed by cisplatin IV over 1 hour twice a week for the first 3 weeks of radiotherapy Beginning 4 weeks after the completion of radiotherapy patients receive gemcitabine IV over 30 minutes on days 1 8 and 15 Treatment repeats every 28 days for a total of 3 courses in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline at completion of radiotherapy at completion of chemotherapy and 3 months after completion of therapy
Patients are followed every 3 months for 2 years and then every 6 months for 1 year
PROJECTED ACCRUAL A total of 20-47 patients will be accrued for this study within 12-28 months
Determine the efficacy of gemcitabine cisplatin and radiotherapy in terms of 1-year survival in patients with locally advanced pancreatic cancer
Determine the toxicity of this regimen in these patients
Determine the quality of life of patients treated with this regimen
OUTLINE This is a multicenter study
Patients undergo radiotherapy once daily five days a week for 55 weeks Patients receive gemcitabine IV over 30 minutes followed by cisplatin IV over 1 hour twice a week for the first 3 weeks of radiotherapy Beginning 4 weeks after the completion of radiotherapy patients receive gemcitabine IV over 30 minutes on days 1 8 and 15 Treatment repeats every 28 days for a total of 3 courses in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline at completion of radiotherapy at completion of chemotherapy and 3 months after completion of therapy
Patients are followed every 3 months for 2 years and then every 6 months for 1 year
PROJECTED ACCRUAL A total of 20-47 patients will be accrued for this study within 12-28 months
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 |
|---|---|---|---|
| CDR0000069026 | REGISTRY | PDQ Physician Data Query | None |
| NCI-2012-02426 | REGISTRY | None | None |