Status:
TERMINATED
Phase II Trial of 64Cu-ATSM PET/CT in Cervical Cancer
Lead Sponsor:
American College of Radiology
Collaborating Sponsors:
National Cancer Institute (NCI)
American College of Radiology Imaging Network
Conditions:
Cervical Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Diagnostic procedures, such as 64Cu-labeled diacetyl-bis\[N4-methylthiosemicarbazone\] (copper Cu 64-ATSM) PET/CT scans, may help doctors predict how patients will respond to treatment. PU...
Detailed Description
OBJECTIVES: Primary * To define the role of pre-therapy \^64Cu-labeled diacetyl-bis(N4-methylthiosemicarbazone) (copper Cu 64-ATSM) in predicting prognosis and determining the behavior of an invasiv...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed primary invasive cervical squamous cell carcinoma
- Newly diagnosed disease
- Stage IB2 - IVA disease based on FIGO staging system
- Plan to receive standard of care treatment with concurrent cisplatin and radiation therapy (external beam and brachytherapy) per NCCN guidelines
- Must be scheduled to receive 6 weekly courses of cisplatin
- Meets 1 of the following criteria:
- Pelvic nodal (or no nodal) disease only by FDG-PET/CT scan within 4 weeks of enrollment
- Para-aortic nodal metastasis by FDG-PET/CT scan within 4 weeks of enrollment, and patient will undergo radiotherapy to para-aortic nodes
- FDG-PET/CT scan at baseline if not meeting any of the above criteria
- No stage IVB disease (distant metastases or supraclavicular metastasis) confirmed by FDG-PET/CT scan
- No recurrent invasive carcinoma of the uterine cervix regardless of previous treatment
- No know metastases to lungs, supraclavicular lymph nodes, or other organs outside of the pelvis or abdominal lymph nodes at time of diagnosis
- PATIENT CHARACTERISTICS:
- Karnofsky performance status 70-100%
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Able to lie flat for the duration of the PET/CT scan
- No septicemia or severe infection
- No uncontrolled or poorly controlled diabetes
- No circumstances that would prevent completion of imaging studies or required clinical follow-up
- No other prior or concurrent invasive malignancies, with the exception of non-melanoma skin cancer, within the past 5 years
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior pelvic or abdominal lymphadenectomy
- No prior pelvic radiation therapy
- No previous cancer treatment contraindicates this protocol therapy
Exclusion
Key Trial Info
Start Date :
July 29 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2011
Estimated Enrollment :
73 Patients enrolled
Trial Details
Trial ID
NCT00794339
Start Date
July 29 2009
End Date
December 31 2011
Last Update
August 14 2023
Active Locations (2)
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1
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90089-9181
2
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
St Louis, Missouri, United States, 63110