Status:
UNKNOWN
The Efficacy and Safety of Nerve-sparing Radical Hysterectomy in Cervical Cancer
Lead Sponsor:
Asan Medical Center
Conditions:
Cervical Cancer
Eligibility:
FEMALE
18-70 years
Phase:
NA
Brief Summary
To develope nerve sparing radical hysterectomy for treatment of cervical cancer to minimize the complication of radical hysterectomy and to maximize quality of life and to evaluate the feasibility and...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Histologically diagnosed cervical cancer
- FIGO stage IA2-IIA
- Diameter of tumor is less than 4cm on exam
- One of hitological type written below squamous cell carcinoma, adenocarcinoma, adenosquamous cell carcinoma
- Age between 18-70
- Performance status; GOG 0-1
- Normal hematological, hepatic, nephrologic function WBC ≥ 4000 cells/mm3 Platelet ≥ 100,000 /mm3 Hemoglobin ≥ 8.0 gm/dL Serum creatinin ≤ 1.3 mg/dL Serum bilirubin ≤ 1.5 mg/dL SBOT/SGPT and Alkaline phoaphatase \< normal X 3
- Patient with informed consent
- Exclusion creteria:
- Small cell carcinoma
- Unable to perform surgery because of severe underlying medical disease severe heart disease, congestive heart failure/severe pulmonary disease, pulmonary failure/ active bacterial infectio which needs non oral antibiotic therapy/ associated with other severe medical diseases
- Prior chemotherapy or radiotherapy
- Severe bladder funtion abnormality
- Double primary malignant tumor
- Psychiatric problems
- Pregnant or breast feeding status
- Legally unable to participate clinical trial
- When there is a Doctor's decision that patient is unable to participate clinical trial
Exclusion
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2018
Estimated Enrollment :
146 Patients enrolled
Trial Details
Trial ID
NCT01893333
Start Date
March 1 2013
End Date
March 1 2018
Last Update
May 31 2017
Active Locations (1)
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1
Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center
Seoul, South Korea, 138-736