Ignite Creation Date:
2024-05-05 @ 4:55 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00346125
Status:
COMPLETED
Last Update Posted:
2022-12-15
First Post:
2006-06-28
Brief Title:
PET CT as Predictor of Response in Preoperative Chemotherapy for Soft Tissue Sarcoma
Sponsor:
Masonic Cancer Center University of Minnesota
Organization:
Masonic Cancer Center University of Minnesota
Study Overview
Official Title:
An Evaluation of PETCT Imaging as a Predictor of Disease Free Survival Following Neo-Adjuvant Chemotherapy for Soft Tissue Sarcoma
Status:
COMPLETED
Status Verified Date:
2022-12
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 Diagnostic procedures such as positron emission tomography PET scan and computated tomography CT scan may help doctors predict a patients response to treatment and may help plan the best treatment Drugs used in chemotherapy such as doxorubicin and ifosfamide work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed
PURPOSE This clinical trial is studying how well PET scan combined with CT scan predicts response in patients undergoing chemotherapy and surgery for soft tissue sarcoma
PURPOSE This clinical trial is studying how well PET scan combined with CT scan predicts response in patients undergoing chemotherapy and surgery for soft tissue sarcoma
Detailed Description:
OBJECTIVES
Primary
Determine whether measurements of fludeoxyglucose FDG positron emission tomography PETCT imaging can accurately predict disease-free survival of patients with soft tissue sarcoma who are receiving neoadjuvant chemotherapy
Secondary
Correlate histological response to neoadjuvant chemotherapy for soft tissue sarcomas with FDG-PETCT imaging findings
Tertiary
Determine the changes in FDG-PETCT imaging over time as each course of chemotherapy is given
OUTLINE Patients receive 1 of 2 standard chemotherapy regimens
Preferred regimen Patients receive pegylated doxorubicin HCl liposome IV on day 1 ifosfamide IV continuously on days 1-6 and pegfilgrastim subcutaneously SC on day 8 Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity
Alternative regimen Patients receive doxorubicin hydrochloride IV continuously on days 1-7 Patients also receive ifosfamide and pegfilgrastim as in the preferred regimen Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity
All patients undergo a fludeoxyglucose positron emission tomographyCT scan at baseline after course 1 and after completion of chemotherapy Patients undergo surgery within 4-6 weeks after completion of chemotherapy
After completion of study treatment and surgery patients are followed every 6 months for 5 years
PROJECTED ACCRUAL A total of 62 patients will be accrued for this study
Primary
Determine whether measurements of fludeoxyglucose FDG positron emission tomography PETCT imaging can accurately predict disease-free survival of patients with soft tissue sarcoma who are receiving neoadjuvant chemotherapy
Secondary
Correlate histological response to neoadjuvant chemotherapy for soft tissue sarcomas with FDG-PETCT imaging findings
Tertiary
Determine the changes in FDG-PETCT imaging over time as each course of chemotherapy is given
OUTLINE Patients receive 1 of 2 standard chemotherapy regimens
Preferred regimen Patients receive pegylated doxorubicin HCl liposome IV on day 1 ifosfamide IV continuously on days 1-6 and pegfilgrastim subcutaneously SC on day 8 Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity
Alternative regimen Patients receive doxorubicin hydrochloride IV continuously on days 1-7 Patients also receive ifosfamide and pegfilgrastim as in the preferred regimen Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity
All patients undergo a fludeoxyglucose positron emission tomographyCT scan at baseline after course 1 and after completion of chemotherapy Patients undergo surgery within 4-6 weeks after completion of chemotherapy
After completion of study treatment and surgery patients are followed every 6 months for 5 years
PROJECTED ACCRUAL A total of 62 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| UMN-0512M78446 | OTHER | IRB University of Minnesota | None |