Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002689
Status:
COMPLETED
Last Update Posted:
2013-07-18
First Post:
1999-11-01
Brief Title:
Radiation Therapy Plus Chemotherapy in Treating Patients With Pancreatic Cancer
Sponsor:
Center for Molecular Medicine
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Interstitial Colloidal 32P Integrated in The Treatment of Non-Resectable Pancreatic Cancer
Status:
COMPLETED
Status Verified Date:
2007-06
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 Radiation therapy uses high-energy x-rays to damage tumor cells Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Radiation therapy combined with chemotherapy may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of brachytherapy followed by external-beam radiation therapy plus chemotherapy in treating patients who have pancreatic cancer that cannot be removed surgically
PURPOSE Phase II trial to study the effectiveness of brachytherapy followed by external-beam radiation therapy plus chemotherapy in treating patients who have pancreatic cancer that cannot be removed surgically
Detailed Description:
OBJECTIVES
Determine the responseremission rate survival and degree of local control from interstitial colloidal phosphorus P32 followed by external beam radiotherapy and chemotherapy in patients with unresectable pancreatic cancer
OUTLINE Patients are stratified according to prior therapy yes vs no
Patients receive dexamethasone intratumorally then macroaggregated albumin and interstitial phosphorus P32 intratumorally Most patients receive a second course of this brachytherapy
Patients then proceed to chemoradiotherapy beginning 7-14 days after brachytherapy Radiotherapy is administered 5 days a week for 64 weeks Fluorouracil IV is administered every other day for 4 doses during weeks 1 and 2
Patients are followed monthly for 1 year then every 3 months thereafter
PROJECTED ACCRUAL A total of 48 patients will be accrued for this study
Determine the responseremission rate survival and degree of local control from interstitial colloidal phosphorus P32 followed by external beam radiotherapy and chemotherapy in patients with unresectable pancreatic cancer
OUTLINE Patients are stratified according to prior therapy yes vs no
Patients receive dexamethasone intratumorally then macroaggregated albumin and interstitial phosphorus P32 intratumorally Most patients receive a second course of this brachytherapy
Patients then proceed to chemoradiotherapy beginning 7-14 days after brachytherapy Radiotherapy is administered 5 days a week for 64 weeks Fluorouracil IV is administered every other day for 4 doses during weeks 1 and 2
Patients are followed monthly for 1 year then every 3 months thereafter
PROJECTED ACCRUAL A total of 48 patients will be accrued for this study
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 |
|---|---|---|---|
| CDR0000064415 | REGISTRY | None | None |
| CHUMC-95079 | None | None | None |
| NCI-V95-0760 | Registry Identifier | PDQ Physician Data Query | None |