Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003591
Status:
COMPLETED
Last Update Posted:
2013-11-13
First Post:
1999-11-01
Brief Title:
Radiation Therapy Plus Paclitaxel in Treating Patients With Nonmetastatic Unresectable Pancreatic Cancer
Sponsor:
Radiation Therapy Oncology Group
Organization:
Radiation Therapy Oncology Group
Study Overview
Official Title:
A Phase II Trial of External Irradiation 504 GY and Weekly Paclitaxel Taxol for Non-Metastatic Unresectable Pancreatic Cancer
Status:
COMPLETED
Status Verified Date:
2013-11
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 Combining radiation therapy with chemotherapy may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of radiation therapy plus paclitaxel in treating patients who have nonmetastatic unresectable pancreatic cancer
PURPOSE Phase II trial to study the effectiveness of radiation therapy plus paclitaxel in treating patients who have nonmetastatic unresectable pancreatic cancer
Detailed Description:
OBJECTIVES I Determine the response rate of patients with nonmetastatic unresectable pancreatic cancer receiving external beam irradiation and weekly paclitaxel II Determine the median survival after this treatment in these patients III Evaluate the acute and late treatment morbidity of paclitaxel in these patients IV Correlate p53 status with treatment response to this treatment in this patient population
OUTLINE This is a open label multicenter study Patients are highly recommended to undergo laparoscopic surgical staging prior to protocol to exclude peritoneal and hepatic metastases Patients receive paclitaxel IV over 3 hours weekly for 6 weeks beginning on day 1 followed 15 hours later by external beam radiotherapy daily 5 days a week for 55 weeks beginning on day 1 All patients are restaged with an abdominal CT scan 6 weeks following completion of chemoradiotherapy If there is marked response to treatment at this time curative surgery may be attempted at the discretion of the attending surgeon Patients are followed every 3 months for 1 year every 4 months for the second year every 6 months for years 3-5 and annually thereafter
PROJECTED ACCRUAL A total of 100 patients will be accrued into this study over 12 months
OUTLINE This is a open label multicenter study Patients are highly recommended to undergo laparoscopic surgical staging prior to protocol to exclude peritoneal and hepatic metastases Patients receive paclitaxel IV over 3 hours weekly for 6 weeks beginning on day 1 followed 15 hours later by external beam radiotherapy daily 5 days a week for 55 weeks beginning on day 1 All patients are restaged with an abdominal CT scan 6 weeks following completion of chemoradiotherapy If there is marked response to treatment at this time curative surgery may be attempted at the discretion of the attending surgeon Patients are followed every 3 months for 1 year every 4 months for the second year every 6 months for years 3-5 and annually thereafter
PROJECTED ACCRUAL A total of 100 patients will be accrued into this study over 12 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 |
|---|---|---|---|
| CDR0000066661 | None | None | None |