Phase III Trial for Primary Radiotherapy With Single-Agent Cisplatin or Combination Chemotherapy in PET/CT Defined Poor-Prognostic Cervical Cancer Patients
35 Years
70 Years
Female
Cervical Cancer
Trial Information
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
progression-free survival.
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
Inclusion Criteria:
- Histologically confirmed primary squamous cell carcinoma of the uterine cervix.
- Previously untreated disease.
- Clinical FIGO stage III-IVa or pelvic/para-aortic lymph node positive by PET
examination.
- No known metastases to supraclavicular nodes or other organs outside the radiotherapy
field.
- Ages eligible: 35 years - 70 years.
- Patients must have adequate bone marrow, pulmonary, liver and renal function
documented before radiotherapy. WBC > 3000/mm3, platelet > 100,000/mm3, serum
transaminases (GOT, GPT) < 60 IU/ml, total bilirubin < 1.5mg%, creatinine < 1.4mg%
(creatinine clearance > 60 ml/min).
- Performance status 0 or 1 (see Appendix I).
- The interval between RT and randomization is not greater than 3 weeks.
- Patients must have signed informed consent to participate this study.
Exclusion Criteria:
- Age > 70 or < 35
- Medical or psychological condition that would preclude treatment.
- Previous chemotherapy or pelvic RT.
- Small cell carcinoma, adenocarcinoma or adenosquamous carcinoma.
- Patient unreliable for treatment completion and follow-up.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
Patient survival, including overall survival and progression-free survival.
Outcome Time Frame:
2012,
Safety Issue:
Yes
Principal Investigator
Chun Chieh Wang, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Chang Gung Memorial Hospital
Authority:
Taiwan: Department of Health
Study ID:
97-1165A3
NCT ID:
NCT00842660
Start Date:
February 2009
Completion Date:
January 2013
Related Keywords:
- Cervical Cancer
- Cervical cancer
- concurrent chemoradiotherapy
- gemcitabine
- Uterine Cervical Neoplasms
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