Ignite Creation Date:
2024-05-05 @ 11:27 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00049231
Status:
COMPLETED
Last Update Posted:
2013-06-24
First Post:
2002-11-12
Brief Title:
EF5 to Detect Tumor Hypoxia in Patients With Stage IIB Stage IIIB or Stage IVA Cervical Cancer
Sponsor:
Gynecologic Oncology Group
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Evaluation of Hypoxia by EF5 NSC684681 Binding in Cervix Cancer
Status:
COMPLETED
Status Verified Date:
2005-06
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 Knowing the level of oxygen in tumor tissue may help predict the effectiveness of anticancer therapy EF5 may be effective in measuring oxygen in tumor tissue and helping to predict the effectiveness of anticancer therapy
PURPOSE Diagnostic trial to study the effectiveness of EF5 in detecting tumor hypoxia in patients who have stage IIB stage IIIB or stage IVA cervical cancer
PURPOSE Diagnostic trial to study the effectiveness of EF5 in detecting tumor hypoxia in patients who have stage IIB stage IIIB or stage IVA cervical cancer
Detailed Description:
OBJECTIVES
Determine the relationship between the level of EF5 binding and pretreatment hemoglobin level tumor size and stage of disease in patients with stage IIB IIIB or IVA cervical cancer
Determine whether pretreatment tumor hypoxia measured by EF5 binding is associated with overall survival progression-free interval and local control in these patients
Determine the relationship between EF5 binding and CD-31 labeling tumor vasculature and Ki-67 labeling cellular proliferation in these patients
OUTLINE This is a multicenter study
Patients receive EF5 IV over 1-25 hours on day 1 Tumor hypoxia is measured using immunohistochemical techniques Biopsies are collected 1-2 days later Blood is collected before EF5 is administered and again at the time of surgery
Patients are followed approximately 1 month after surgery
PROJECTED ACCRUAL A total of 150 patients will be accrued for this study within 3 years
Determine the relationship between the level of EF5 binding and pretreatment hemoglobin level tumor size and stage of disease in patients with stage IIB IIIB or IVA cervical cancer
Determine whether pretreatment tumor hypoxia measured by EF5 binding is associated with overall survival progression-free interval and local control in these patients
Determine the relationship between EF5 binding and CD-31 labeling tumor vasculature and Ki-67 labeling cellular proliferation in these patients
OUTLINE This is a multicenter study
Patients receive EF5 IV over 1-25 hours on day 1 Tumor hypoxia is measured using immunohistochemical techniques Biopsies are collected 1-2 days later Blood is collected before EF5 is administered and again at the time of surgery
Patients are followed approximately 1 month after surgery
PROJECTED ACCRUAL A total of 150 patients will be accrued for this study within 3 years
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 |
|---|---|---|---|
| GOG-8002 | None | None | None |