Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004089
Status:
COMPLETED
Last Update Posted:
2013-07-10
First Post:
1999-12-10
Brief Title:
Chemotherapy Plus Radiation Therapy in Treating Patients With Previously Untreated Thyroid Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Multicenter Phase II Study of Intensified Concomitant Chemoradiotherapy for Patients With Anaplastic Thyroid Cancer
Status:
COMPLETED
Status Verified Date:
2011-01
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 Radiation therapy uses high-energy x-rays to damage tumor cells 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 previously untreated anaplastic thyroid cancer
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating patients who have previously untreated anaplastic thyroid cancer
Detailed Description:
OBJECTIVES I Evaluate the activity of chemotherapy with hyperfractionated radiotherapy in terms of complete and overall response rate time to progression pattern of failure incidence of second primary tumors and overall survival in patients with previously untreated anaplastic thyroid cancer
OUTLINE This is a multicenter study Patients receive oral hydroxyurea every 12 hours on days 0-5 fluorouracil IV and paclitaxel IV continuously over days 1-5 and hyperfractionated radiotherapy twice daily on days 1-5 Patients receive filgrastim G-CSF subcutaneously daily on days 6-12 Treatment repeats every 2 weeks for 5 courses Following completion of concurrent chemoradiotherapy patients with no prior initial modified neck dissection who have residual macroscopic nodal disease or initially staged nodal disease with no evidence of residual disease undergo neck dissection Patients with macroscopic residual disease at the primary site undergo complete excision of disease Patients with any progressive disease or recurrence of disease undergo conventional surgical management Patients are followed at 4-6 weeks every 3 months for 1 year and then annually thereafter
PROJECTED ACCRUAL Approximately 16-46 patients will be accrued for this study
OUTLINE This is a multicenter study Patients receive oral hydroxyurea every 12 hours on days 0-5 fluorouracil IV and paclitaxel IV continuously over days 1-5 and hyperfractionated radiotherapy twice daily on days 1-5 Patients receive filgrastim G-CSF subcutaneously daily on days 6-12 Treatment repeats every 2 weeks for 5 courses Following completion of concurrent chemoradiotherapy patients with no prior initial modified neck dissection who have residual macroscopic nodal disease or initially staged nodal disease with no evidence of residual disease undergo neck dissection Patients with macroscopic residual disease at the primary site undergo complete excision of disease Patients with any progressive disease or recurrence of disease undergo conventional surgical management Patients are followed at 4-6 weeks every 3 months for 1 year and then annually thereafter
PROJECTED ACCRUAL Approximately 16-46 patients will be accrued for this study
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 |
|---|---|---|---|
| NCI-G99-1580 | None | None | None |
| NU-V96N3 | None | None | None |
| UCCRC-08200 | None | None | None |