Status:
WITHDRAWN
The Gene Expression Studies of the Role of Tumor Microenvironments in Tumor Progression
Lead Sponsor:
Duke University
Conditions:
Hypoxia
Lactic Acidosis
Eligibility:
FEMALE
18-50 years
Brief Summary
The purpose of this study is to analyze the gene expression patterns associated with various microenvironmental stresses in tumors to understand their roles in tumor progression and treatment response...
Detailed Description
In the first part of the proposal, we will determine the cellular responses to various microenvironmental factors (such as lactosis, acidosis, hypoxia, glucose deprivation) in cultured epithelial cell...
Eligibility Criteria
Inclusion
- Invasive cervical carcinoma (small cell histology excluded)
- Age 18 or over
- FIGO stage IIb-IVa
- ECOG/WHO 0,1, or 2, or \>/= 70% respectively
- WBC \>/= 3,000, platelets \>/= 100,000
- Hgb\>12.0 g/dL or \>7.5 mmol/L, with transfusion if needed
- Serum bilirubin \</= 1.5 times ULN, transaminase \</= 3 times ULN
- Calculated creatinine clearance \> 60 ml/liter (Cockcroft)
- Para-aortic adenopathy absent or 1.5 cm in greatest dimension on CT/MRI
- No history of myocardial infarction in the last 6 months
- No symptomatic angina pectoris
- Any past history of coronary artery disease must require assessment and clearance by the PCP and/or cardiologist
- Negative pregnancy test in patients under 50
- Written informed consent
Exclusion
- Patients who have undergone surgical resection of the primary tumor are not eligible (Limited surgical resection of pelvic nodes without TAH is acceptable)
- Patients with pacemakers or implanted defibrillators
- Patients with significant metallic foreign bodies (i.e. hip replacements, bone metallic rods, orthopedic plates, etc.)
- Prior radiotherapy or chemotherapy
Key Trial Info
Start Date :
September 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00638040
Start Date
September 1 2009
End Date
September 1 2012
Last Update
July 11 2014
Active Locations (1)
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1
Duke Medical Center
Durham, North Carolina, United States, 27708