Phase II Study of Weekly Paclitaxel and Cisplatin in FIGO IB2 and IIA2 Cervical Cancer Followed by Radical Hysterectomy
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Enrollment
- 64
- Locations
- 3
- Primary Endpoint
- overall survivial
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 35 Years to 70 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
Weekly paclitaxel and 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
Intervention: paclitaxel (Drug)
Weekly paclitaxel and 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
Intervention: cisplatin (Drug)
Weekly paclitaxel and 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
Intervention: Radical hysterectomy and bilateral pelvic lymphadenectomy (Procedure)
Outcomes
Primary Outcomes
overall survivial
Time Frame: 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 Outcomes
- Safety (If > 6 significant G3/4 AEs occur)(January 31, 2023 (up to 5 years))
- Response rate (Pathological response)(Post-operative 1 month)
- Postoperative RT/CRT rate(Post-operative 6 months)
- Quality-of-life(at completion of neoadjuvant chemotherapy)
- Progression-free survival(January 31, 2023 (up to 5 years))
Investigators
Huei-Jean Huang
MD
Chang Gung Memorial Hospital