Ignite Creation Date:
2024-05-05 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00093509
Status:
COMPLETED
Last Update Posted:
2014-09-01
First Post:
2004-10-06
Brief Title:
MRI Sarcoma Non Invasive Thermometry
Sponsor:
Mark Dewhirst
Organization:
Duke University
Study Overview
Official Title:
Magnetic Resonance Based Non-Invasive Thermometry for Hyperthermic Treatment of Extremity Soft Tissue Sarcomas A Multimodal Phase III Study
Status:
COMPLETED
Status Verified Date:
2014-08
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 Hyperthermia therapy kills tumor cells by heating them to several degrees above body temperature Using MRI to measure heat may help to determine the effectiveness of hyperthermia therapy Radiation therapy uses high-energy x-rays to damage tumor cells Drugs used in chemotherapy such as ifosfamide and doxorubicin work in different ways to stop tumor cells from dividing so they stop growing or die Combining hyperthermia with radiation therapy and chemotherapy before surgery may kill more tumor cells and shrink the tumor so that it can be removed
PURPOSE This phase III trial is studying the side effects of hyperthermia when given together with radiation therapy and optional chemotherapy and to see how well they work in treating patients who are undergoing surgery for soft tissue sarcoma of the limbs
PURPOSE This phase III trial is studying the side effects of hyperthermia when given together with radiation therapy and optional chemotherapy and to see how well they work in treating patients who are undergoing surgery for soft tissue sarcoma of the limbs
Detailed Description:
OBJECTIVES
Primary
Determine the feasibility and accuracy of real time magnetic resonance-based non-invasive thermometry in patients with grade 2 or 3 soft tissue sarcoma of the extremity receiving combination hyperthermia radiotherapy surgery and optional high-dose ifosfamide and doxorubicin
Secondary
Determine the local control disease-free survival and overall survival of patients treated with this regimen
Determine acute and late toxic effects of this regimen in these patients
Correlate measurements of tumor physiology defined by gadolinium-enhanced magnetic resonance imaging magnetic resonance spectroscopy and tumor oxygenation with clinical andor pathological response andor metastatic potential in patients treated with this regimen
OUTLINE Patients may receive high-dose ifosfamide IV continuously over 6 days 144 hours Beginning 3 weeks after the completion of ifosfamide patients undergo radiotherapy once daily 5 days a week for 5 weeks Beginning 1 hour after radiotherapy patients also undergo hyperthermia with heat measured by conventional and magnetic resonance-based thermometry over 1-2 hours once weekly for 5 weeks Approximately 4 weeks after the completion of radiotherapy and hyperthermia patients undergo surgery Approximately 1 month after surgery patients may then receive high-dose doxorubicin IV once every 4 weeks for 4 courses
PROJECTED ACCRUAL A total of 10-30 patients will be accrued for this study within 2-6 years
Primary
Determine the feasibility and accuracy of real time magnetic resonance-based non-invasive thermometry in patients with grade 2 or 3 soft tissue sarcoma of the extremity receiving combination hyperthermia radiotherapy surgery and optional high-dose ifosfamide and doxorubicin
Secondary
Determine the local control disease-free survival and overall survival of patients treated with this regimen
Determine acute and late toxic effects of this regimen in these patients
Correlate measurements of tumor physiology defined by gadolinium-enhanced magnetic resonance imaging magnetic resonance spectroscopy and tumor oxygenation with clinical andor pathological response andor metastatic potential in patients treated with this regimen
OUTLINE Patients may receive high-dose ifosfamide IV continuously over 6 days 144 hours Beginning 3 weeks after the completion of ifosfamide patients undergo radiotherapy once daily 5 days a week for 5 weeks Beginning 1 hour after radiotherapy patients also undergo hyperthermia with heat measured by conventional and magnetic resonance-based thermometry over 1-2 hours once weekly for 5 weeks Approximately 4 weeks after the completion of radiotherapy and hyperthermia patients undergo surgery Approximately 1 month after surgery patients may then receive high-dose doxorubicin IV once every 4 weeks for 4 courses
PROJECTED ACCRUAL A total of 10-30 patients will be accrued for this study within 2-6 years
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 |
|---|---|---|---|
| DUMC-1308-04-7R5 | OTHER | None | None |
| DUMC-G880018 | None | None | None |
| CDR0000388048 | OTHER | National Cancer Institute NCI | None |