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Brief Title: Study of Weekly Paclitaxel and Cisplatin in FIGO IB2 and IIA2 Cervical Cancer Followed by Radical Hysterectomy
Official Title: Phase II Study of Weekly Paclitaxel and Cisplatin in FIGO IB2 and IIA2 Cervical Cancer Followed by Radical Hysterectomy
Study ID: NCT02432365
Brief Summary: The purpose was to establish a quick (7-day) cycle schedule of paclitaxel (60 mg/m2) combining with cisplatin (40 mg/m2) NAC regimen could be tolerated without interfering the following surgical treatment and a favorable overall survival rate for stages IB2 and IIA2 cervical squamous cell carcinoma (SCC).
Detailed Description: This is a multi-center, open-label, Simon's 2-stage, phase II study of paclitaxel and cisplatin as neoadjuvant therapy in patients with FIGO IB2 or IIA2, squamous cell cervical carcinoma of the uterine cervix. Primary Objectives: • Overall survival Secondary Objectives: * Safety * Progression-free survival * Response rate * Postoperative RT/CRT rate * To assess Quality-of-life An estimate of 64 evaluable patients will be enrolled in this phase II investigation.
Minimum Age: 35 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: Yes
Department of Obstetrics & Gynecology, Chang Gung Memorial Hospital, Chiayi City, , Taiwan
Department of Obstetrics & Gynecology, Chang Gung Memorial Hospital, Kaohsiung, , Taiwan
Department of Obstetrics and Gynecology, Chung Shan Medical University Hospital, Taichung, , Taiwan
Department of Obstetrics & Gynecology, Chang Gung Memorial Hospital, Taipei, , Taiwan
Division of Gynecologic Oncology, Department of Obstetrics & Gynecology, Chang Gung Memorial Hospital Linkou Medical Center, Taoyuan, , Taiwan
Name: Huei-Jean Huang, M.D
Affiliation: Gynecologic oncology
Role: PRINCIPAL_INVESTIGATOR