Study of Weekly Paclitaxel and Cisplatin in FIGO IB2 and IIA2 Cervical Cancer Followed by Radical Hysterectomy
- Conditions
- Cervical Cancer
- Interventions
- Registration Number
- NCT02432365
- Lead Sponsor
- Chang Gung Memorial Hospital
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 64
-
Women with previously untreated, histologically confirmed squamous cell carcinoma of the uterine cervix
-
HPV16-positive aged 35-70 years or HPV16-negative age <55 years
-
FIGO stage IB2 or bulky IIA, with tumor extending to the vagina within the upper one third of the vaginal wall. Bulky tumor is defined as
- a visible cervical tumor with the largest diameter >4 cm or (b) a cervix expanded to > 4 cm as a result of tumor infiltration by pelvic examination
- verified by magnetic resonance image (MRI) or 3-dimensional (D) computed tomography (CT)
-
no suspicious extrapelvic metastasis detected by MRI or 3-D CT
-
adequate marrow, liver and renal functions :hemoglobin level >= 10 g/dL, WBC count >= 3,000/mm3 or absolute neutrophil count >= 1,500/mm3, platelet count >= 100,000/mm3, serum transaminase (AST, ALT) levels <= 60 IU/mL, total serum bilirubin within normal range, serum creatinine level <= 1.5 mg/dL, and blood urea nitrogen level <=20 mg/dL
-
adequate cardiopulmonary function that tolerates the administration of study regimen and radical hysterectomy
-
Eastern Cooperative Oncology Group performance status of 0 to 1
-
had written informed consent to participate in the study
-
Appropriate organ and marrow function :
leukocytes >=3,000/μL absolute neutrophil count >= 1,500/μL platelets >= 100,000/μL (not platelet transfusion dependent) hemoglobin >= 10 g/dL total bilirubin within normal range AST/ALT <= 2.5 X upper limit of normal range (ULN) BUN <= 20 mg/dL serum creatinine <=1.5 mg/dL or clearance > 60 mL/min
-
a negative urinary pregnancy test in a patient with child-bearing potential
Patients will be excluded from the study if they meet any of the following criteria:
- adenocarcinoma , adenosquamous carcinoma, or small cell carcinoma
- concurrent or history of malignant tumor(s) other than treated nonmelanoma skin cancer
- had received surgical procedure other than cervical biopsy or cytotoxic procedure including chemotherapy, radiotherapy or therapy with biologic response modifier(s) for the cervical tumor
- enlarged pelvic lymph node with positive aspiration cytologic or histologic study
- participate in investigational treatment or another clinical trial for cervical cancer
- history of allergic reaction to platinum or paclitaxel
- uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- pregnant or breast feeding women
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Weekly paclitaxel and cisplatin Radical hysterectomy and bilateral pelvic lymphadenectomy 7-day cycle schedule of paclitaxel (60 mg/m2) combining with cisplatin (40 mg/m2) NAC regimen followed by radical hysterectomy and bilateral pelvic lymphadenectomy Weekly paclitaxel and cisplatin paclitaxel 7-day cycle schedule of paclitaxel (60 mg/m2) combining with cisplatin (40 mg/m2) NAC regimen followed by radical hysterectomy and bilateral pelvic lymphadenectomy Weekly paclitaxel and cisplatin cisplatin 7-day cycle schedule of paclitaxel (60 mg/m2) combining with cisplatin (40 mg/m2) NAC regimen followed by radical hysterectomy and bilateral pelvic lymphadenectomy
- Primary Outcome Measures
Name Time Method overall survivial January 31, 2023 (5 years) 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.
- Secondary Outcome Measures
Name Time Method Safety (If > 6 significant G3/4 AEs occur) January 31, 2023 (up to 5 years) If \> 6 significant G3/4 AEs occur
Response rate (Pathological response) Post-operative 1 month Pathological response will be calculated
Postoperative RT/CRT rate Post-operative 6 months Postoperative RT/CCRT will be given to defined high-risk group
Quality-of-life at completion of neoadjuvant chemotherapy using EORTC QLQ-C30, EORTC-QLQ-CX24
Progression-free survival January 31, 2023 (up to 5 years) PFS will be evaluated using Kaplan-Meier method
Trial Locations
- Locations (3)
Division of Gynecologic Oncology, Department of Obstetrics & Gynecology, Chang Gung Memorial Hospital Linkou Medical Center
🇨🇳Taoyuan, Taiwan
Department of Obstetrics & Gynecology, Chang Gung Memorial Hospital
🇨🇳Taipei, Taiwan
Department of Obstetrics and Gynecology, Chung Shan Medical University Hospital
🇨🇳Taichung, Taiwan