Cervical Cancer
Conditions
Keywords
recurrent cervical cancer, stage IB cervical cancer, stage IIA cervical cancer, stage IIB cervical cancer, stage III cervical cancer, stage IVA cervical cancer, stage IVB cervical cancer
Brief summary
RATIONALE: Diagnostic procedures, such as fluorine F 18 EF5 PET/CT imaging, may help find oxygen in tumor cells. It may also help doctors predict a patient's response to treatment and help plan the best treatment. PURPOSE: This trial is studying fluorine F 18 EF5 PET/CT imaging to see how well it works in finding hypoxia in tumor cells of patients with locally advanced or recurrent/metastatic cervical cancer.
Detailed description
OBJECTIVES: * To determine if the presence and heterogeneity of hypoxia can be detected by fluorine F 18 EF5 binding in tumors during PET/CT imaging in patients with newly diagnosed or recurrent carcinoma of the cervix. * To determine if fludeoxyglucose F 18 uptake correlates with fluorine F 18 EF5 uptake. * To assess the relationship between fluorine F 18 EF5 uptake and disease-free and overall survival. OUTLINE: Patients are stratified according to disease stage (locally advanced vs recurrent or metastatic disease). Patients receive fluorine F 18 EF5 IV followed by PET/CT imaging from the base of skull to upper thigh at baseline and during radiotherapy or chemotherapy (i.e., at 3-4 weeks after the initiation of radiotherapy or after the 4th, 5th, or 6th course of chemotherapy). Patients also undergo fludeoxyglucose F 18 PET/CT imaging within 7 to 10 days of the second fluorine F 18 EF5 scan. After completion of study treatment, patients are followed up at 30 days and then annually thereafter.
Interventions
RADIATIONfludeoxyglucose F 18
RADIATIONfluorine F 18 EF5
Sponsors
National Cancer Institute (NCI)
Abramson Cancer Center at Penn Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 120 Years
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Diagnosis of carcinoma of the cervix meeting 1 of the following criteria: * Pathologically confirmed, newly diagnosed stage IB-IVA (locally advanced) disease * Imaging evidence of recurrent or metastatic disease * Measurable disease, defined as ≥ 1 cm on anatomic imaging PATIENT CHARACTERISTICS: * Karnofsky performance status 70-100% * WBC \> 2,000/mm³ * Platelet count \> 90,000/mm³ * Total bilirubin \< 2.0 mg/dL * Creatinine \< 2.0 mg/dL * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No history of allergic reactions attributed to Flagyl (metronidazole) * No other condition or personal circumstance that, in the judgment of the Investigator, may interfere with the collection of complete, good-quality data PRIOR CONCURRENT THERAPY: * Not specified
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relationship Between Fluorine F 18 EF5 Uptake and Disease-free Survival and Overall Survival | 7 years | The study was terminated and no data are available to be reported |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Subjects fludeoxyglucose F 18
fluorine F 18 EF5 | 0 |
| Total | 0 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Relationship Between Fluorine F 18 EF5 Uptake and Disease-free Survival and Overall Survival
The study was terminated and no data are available to be reported
Time frame: 7 years
Population: The study was terminated and no data are available to be reported