Systemic Consolidation Therapy After Chemoradiation Therapy Following Operation for High Risk Early Stage Cervical Cancer
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ClinicalTrials.gov Identifier: NCT00592059
Recruitment Status : Unknown
Verified December 2007 by Seoul National University Hospital. Recruitment status was: Recruiting
The purpose of this study is to determine the therapeutic efficacy and complications of systemic consolidation therapy with paclitaxel plus carboplatin following radical hysterectomy and adjuvant chemoradiation for high risk early stage cervical cancer.
Condition or disease
Systemic consolidation therapy with paclitaxel plus carboplatin (3 cycles per 3 weeks) following radical hysterectomy and adjuvant chemoradiation (3 cycles per 3 weeks) for high risk early stage cervical cancer will elevate the therapeutic efficacy by removing the microscopic metastatic lesions which could not be identified by naked eye and diagnostic imaging tests.
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Ages Eligible for Study:
20 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
patients who underwent radical hysterectomy for cervical cancer stage IB-IIA
Patients who had at least one of the following risk factors in pathologic results; lymph node metastasis, positive residual resection margin, parametrial invasion
above 20 years
GOG performance status 0-2
Platelet>100K, Hb> 10.0 g/dl, ANC>1500/mm3, Cr <1.25*upper normal limit, bilirubin<1.5mg/dl, AST & ALT<*3 upper normal limit
Expected life > 6 months
Peripheral neurotoxicity > NCI grade 2
Previous history with chemotherapy or radiation therapy
Pleural effusion, pericardial effusion, and ascites which could cause dyspnea > NCI grade 2
Paraaortic lymph node metastasis
Allergy with platinum
Previous history of atrial or ventricular arrhythmia or congestive heart failure