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).
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
64
7-day cycle schedule of paclitaxel (60 mg/m2)
7-day cycle schedule of cisplatin (40 mg/m2)
2 weeks after last course of neoadjuvant chemotherapy
Department of Obstetrics & Gynecology, Chang Gung Memorial Hospital
Chiayi City, Taiwan
RECRUITINGDepartment of Obstetrics & Gynecology, Chang Gung Memorial Hospital
Kaohsiung City, Taiwan
RECRUITINGDepartment of Obstetrics and Gynecology, Chung Shan Medical University Hospital
Taichung, Taiwan
overall survivial
The primary objective is to determinate the difference in 5-year survival rate of subjects with NAC+RH-PLND compared with standard CCRT. Based on the pilot research, the 5-year survival rate of NAC+RH-PLND is expected to be around 87.5%. Thus, a sample size of 64 subjects in NAC+RH-PLND group is required for correctly detecting a 12.5% difference between 5-year OS rate of NAC+RH-PLND group and a reference value 75% of standard CCRT in order to achieving an 80% power at a significance level 0.05.
Time frame: January 31, 2023 (5 years)
Safety (If > 6 significant G3/4 AEs occur)
If \> 6 significant G3/4 AEs occur
Time frame: January 31, 2023 (up to 5 years)
Response rate (Pathological response)
Pathological response will be calculated
Time frame: Post-operative 1 month
Postoperative RT/CRT rate
Postoperative RT/CCRT will be given to defined high-risk group
Time frame: Post-operative 6 months
Quality-of-life
using EORTC QLQ-C30, EORTC-QLQ-CX24
Time frame: at completion of neoadjuvant chemotherapy
Progression-free survival
PFS will be evaluated using Kaplan-Meier method
Time frame: January 31, 2023 (up to 5 years)
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Department of Obstetrics & Gynecology, Chang Gung Memorial Hospital
Taipei, Taiwan
RECRUITINGDivision of Gynecologic Oncology, Department of Obstetrics & Gynecology, Chang Gung Memorial Hospital Linkou Medical Center
Taoyuan District, Taiwan
RECRUITING