Radiotherapy With Single-Agent Cisplatin or Combination Chemotherapy in Defined Poor-Prognostic Cervical Cancer
Concurrent radiotherapy with cisplatin-based chemotherapy has become the standard treatment for patients with cervical cancer. However, in patients with advanced cervical cancer, half of them treated with contemporary radiotherapy plus single agent cisplatin still suffered from the local or distant relapse. How to improve the treatment outcome of these patients is a very important issue and requires further clinical investigation.
The major aim of this project is to conduct a prospective, randomized phase III clinical trial to examine if cervical cancer patients treated by radiotherapy with cisplatin and gemcitabine have better survival rates than those treated by radiotherapy with cisplatin alone.
Gemcitabine has been demonstrated to be a good radiosensitizer. In keeping with this, few clinical trials in early phases showed promising results when using concurrent radiotherapy with cisplatin and gemcitabine. According to these positive results, the investigators expect this trial has the potential to improve the survival in patients with advanced cervical cancer, reduce the medical costs due to tumor relapse, and then benefit the whole society.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Phase III Trial for Primary Radiotherapy With Single-Agent Cisplatin or Combination Chemotherapy in PET/CT Defined Poor-Prognostic Cervical Cancer Patients|
- Patient survival, including overall survival and progression-free survival. [ Time Frame: 2012, ] [ Designated as safety issue: Yes ]
- 1) Acute toxicity during treatment 2) Tumor response rates 3) Sites of recurrence 4) Long-term complications and quality of life [ Time Frame: 2013 ] [ Designated as safety issue: Yes ]
|Study Start Date:||February 2009|
|Estimated Study Completion Date:||January 2013|
|Estimated Primary Completion Date:||January 2012 (Final data collection date for primary outcome measure)|
Drug: Gemzar (gemcitabine)
Gemzar(gemcitabine) Hcl has 2'deoxy-2,2'-difluorouridine monohydrochloride
Other Name: GEMCITABINE
I). Study end points Primary end point: Patient survival, including overall survival and progression-free survival.
Secondary end points:
- Acute toxicity during treatment
- Tumor response rates
- Sites of recurrence
- 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
|Chong Jong Wang,|
|Kaohsiung, Taiwan, M.D|
|Principal Investigator:||Chun Chieh Wang, MD||Chang Gung Memorial Hospital|