Basic Trial Information
|Phase II||Diagnostic, Treatment||Closed||18 and over||Other||CDR0000624407|
RATIONALE: Diagnostic procedures, such as copper Cu 64-ATSM PET/CT scans, may help doctors predict how patients will respond to treatment.
PURPOSE: This phase II trial is studying how well copper Cu 64-ATSM PET/CT scans work in predicting disease progression in patients undergoing standard of care treatment with cisplatin and radiation therapy (external beam and brachytherapy) per NCCN guidelines for newly-diagnosed stage IB, stage II, stage III, or stage IVA cervical cancer.
Further Study Information
- 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 invasive squamous cell cervical cancer in patients with newly-diagnosed stage IB2-IVA cervical squamous cell carcinoma.
- To determine whether higher copper Cu 64-ATSM uptake is associated with lower progression-free survival of these patients after chemoradiotherapy.
- To determine if higher copper Cu 64-ATSM uptake is associated with lower overall survival of these patients.
- To determine if higher copper Cu 64-ATSM uptake is associated with earlier primary cervical tumor recurrence and a higher rate of development of distant metastatic disease in these patients.
- To determine if higher copper Cu 64-ATSM uptake is associated with a lower frequency of complete metabolic response on FDG-PET/CT scan performed 3 months after completion of radiotherapy and chemotherapy.
- To estimate the accuracy of copper Cu 64-ATSM uptake as a predictor of progression-free survival, overall survival, primary tumor recurrence, and future development of distant metastatic disease in these patients.
- To evaluate the performance of copper Cu 64-ATSM uptake as a predictor of lymph node metastasis at study entry.
- To evaluate whether copper Cu 64-ATSM uptake correlates with tumor volume at study entry.
- To examine the relationship between tumor uptake of copper Cu 64-ATSM and other markers of tumor hypoxia, including VEGF, GLUT-1, CA-IX, and OPN.
- To compare the predictive ability of pre-therapy copper Cu 64-ATSM-PET to that of post-therapy FDG-PET/CT scan.
- To assess whether pre-therapy FDG-PET/CT findings are predictive of progression-free survival.
OUTLINE: This is a multicenter study.
Patients receive copper Cu 64-ATSM IV and undergo PET/CT scan over 30 minutes 30-40 minutes later. Within 4 weeks after copper Cu 64-ATSM-PET/CT scan, patients begin planned concurrent standard of care chemoradiotherapy comprising 6 weeks of radiotherapy (external beam and brachytherapy)and weekly cisplatin administration per NCCN guidelines. Patients then undergo FDG-PET/CT scan 3 months after completion of chemoradiotherapy.
Tissue samples from previously collected cervical biopsy (obtained for diagnosis) are used for detecting hypoxic markers by immunohistochemistry analysis.
After completion of study intervention, patients are followed for every 3 months for 2 years and then every 6 months for 1 year.
- Histologically confirmed primary invasive cervical squamous cell carcinoma
- 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
- Karnofsky performance status 70-100%
- 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
Trial Lead Organizations/Sponsors
American College of Radiology Imaging Network
Farrokh Dehdashti, Principal Investigator
David A. Mankoff, Study Chair
Case Comprehensive Cancer Center
Charles A Kunos
Link to the current ClinicalTrials.gov record.
NLM Identifier NCT00794339
ClinicalTrials.gov processed this data on April 09, 2015
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