Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00079365
Status:
UNKNOWN
Last Update Posted:
2013-12-04
First Post:
2004-03-08
Brief Title:
Fluorouracil External-Beam Radiation Therapy and Gemcitabine With or Without Brachytherapy Using Phosphorus P32 in Treating Patients With Locally or Regionally Advanced Unresectable Adenocarcinoma of the Pancreas
Sponsor:
University of South Florida
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Randomized Trial Comparing 5-Fluorouracil External Beam Radiation and Gemcitabine With or Without P Radiopharmaceutical Therapy As A First Line Therapy in Patients With LocallyRegionally Advanced Non-Resectable Adenocarcinoma of the Pancreas
Status:
UNKNOWN
Status Verified Date:
2005-05
Last Known Status:
ACTIVE_NOT_RECRUITING
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 gemcitabine work in 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 Fluorouracil may make the tumor cells more sensitive to radiation therapy Brachytherapy uses radioactive material such as phosphorus P32 placed directly into or near a tumor to kill tumor cells Combining chemotherapy and external-beam radiation therapy with brachytherapy may kill more tumor cells
PURPOSE This randomized clinical trial is studying fluorouracil gemcitabine external-beam radiation therapy and brachytherapy using phosphorus P32 to see how well they work compared to fluorouracil gemcitabine and external-beam radiation therapy in treating patients with locally or regionally advanced unresectable adenocarcinoma of the pancreas pancreatic cancer
PURPOSE This randomized clinical trial is studying fluorouracil gemcitabine external-beam radiation therapy and brachytherapy using phosphorus P32 to see how well they work compared to fluorouracil gemcitabine and external-beam radiation therapy in treating patients with locally or regionally advanced unresectable adenocarcinoma of the pancreas pancreatic cancer
Detailed Description:
OBJECTIVES
Primary
Compare the survival of patients with locally or regionally advanced unresectable adenocarcinoma of the pancreas treated with fluorouracil external beam radiotherapy and gemcitabine with vs without brachytherapy with phosphorus P32 suspension
Secondary
Compare time to disease progression tumor response rate and physical performance in patients treated with these regimens
Compare the safety and tolerability of these regimens in this patient population
Compare duration of response and time to treatment failure in patients treated with these regimens
OUTLINE This is a randomized study Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive phosphorus P32 suspension percutaneously under CT guidance on day 0 and at months 1 2 6 7 and 8 Patients receive fluorouracil IV continuously on days 1-5 of weeks 1-6 Patients concurrently undergo external beam radiotherapy 5 days a week on weeks 1-6 At the completion of radiotherapy patients receive gemcitabine IV over 30 minutes once weekly for 7 weeks After a 1-week rest patients then receive gemcitabine IV over 30 minutes once weekly for 3 weeks Treatment repeats every 28 days
Arm II Patients receive fluorouracil and gemcitabine and undergo external beam radiotherapy as in arm I
In both arms treatment continues in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months
PROJECTED ACCRUAL A total of 80 patients 40 per treatment arm will be accrued for this study within 24-30 months
Primary
Compare the survival of patients with locally or regionally advanced unresectable adenocarcinoma of the pancreas treated with fluorouracil external beam radiotherapy and gemcitabine with vs without brachytherapy with phosphorus P32 suspension
Secondary
Compare time to disease progression tumor response rate and physical performance in patients treated with these regimens
Compare the safety and tolerability of these regimens in this patient population
Compare duration of response and time to treatment failure in patients treated with these regimens
OUTLINE This is a randomized study Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive phosphorus P32 suspension percutaneously under CT guidance on day 0 and at months 1 2 6 7 and 8 Patients receive fluorouracil IV continuously on days 1-5 of weeks 1-6 Patients concurrently undergo external beam radiotherapy 5 days a week on weeks 1-6 At the completion of radiotherapy patients receive gemcitabine IV over 30 minutes once weekly for 7 weeks After a 1-week rest patients then receive gemcitabine IV over 30 minutes once weekly for 3 weeks Treatment repeats every 28 days
Arm II Patients receive fluorouracil and gemcitabine and undergo external beam radiotherapy as in arm I
In both arms treatment continues in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months
PROJECTED ACCRUAL A total of 80 patients 40 per treatment arm will be accrued for this study within 24-30 months
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| USFPG-6034 | None | None | None |