Phase III Trial for Primary Radiotherapy With Single-Agent Cisplatin or Combination Chemotherapy in PET/CT Defined Poor-Prognostic Cervical Cancer Patients
I). Study end points Primary end point: Patient survival, including overall survival and
Secondary end points:
1. Acute toxicity during treatment
2. Tumor response rates
3. Sites of recurrence
4. Long-term complications and quality of life II). Design of study
An open-label, prospective randomized trial with two treatment arms:
- Arm I: Patients receive CCRT with weekly cisplatin only.
- Arm II: Patients receive CCRT with cisplatin plus gemcitabine. III). Study population
1) Number of subjects: A total of 172 patients (86 per treatment arm) will be accrued
for this study within 4 years.
Conduct of study
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Patient survival, including overall survival and progression-free survival.
Chun Chieh Wang, MD
Chang Gung Memorial Hospital
Taiwan: Department of Health