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Sponsors and Collaborators: |
Gynecologic Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00049231 |
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.
Condition | Intervention |
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Cervical Cancer |
Drug: EF5 Other: immunohistochemistry staining method Procedure: biopsy |
Study Type: | Interventional |
Study Design: | Diagnostic, Open Label |
Official Title: | Evaluation of Hypoxia by EF5 (NSC#684681) Binding in Cervix Cancer |
Study Start Date: | June 2003 |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive EF5 IV over 1-2.5 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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed invasive squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
United States, Arkansas | |
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | |
Little Rock, Arkansas, United States, 72205 | |
United States, Colorado | |
Colorado Gynecologic Oncology Group P.C. | |
Denver, Colorado, United States, 80218 | |
United States, Missouri | |
Ellis Fischel Cancer Center at University of Missouri - Columbia | |
Columbia, Missouri, United States, 65203 | |
United States, Oklahoma | |
Cancer Care Associates - Midtown Tulsa | |
Tulsa, Oklahoma, United States, 74104 | |
Oklahoma University Medical Center | |
Oklahoma City, Oklahoma, United States, 73104 |
Study Chair: | Gillian M. Thomas, BSc, MD, FRCPC, FRCR (Hon) | Edmond Odette Cancer Centre at Sunnybrook |
Study ID Numbers: | CDR0000258053, GOG-8002 |
Study First Received: | November 12, 2002 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00049231 History of Changes |
Health Authority: | United States: Federal Government |
cervical adenocarcinoma cervical adenosquamous cell carcinoma cervical squamous cell carcinoma |
stage IIB cervical cancer stage III cervical cancer stage IVA cervical cancer |
Uterine Cervical Neoplasms Epidermoid Carcinoma Squamous Cell Carcinoma Adenocarcinoma |
Carcinoma, Squamous Cell Carcinoma, Adenosquamous Carcinoma |