An International Multi Center Phase III Study of Chemoradiotherapy Versus Chemoradiotherapy Plus Hyperthermia for Locally Advanced Cervical Cancer
- Compare local control, failure-free survival, and overall survival of patients with
locally advanced carcinoma of the cervix treated with cisplatin and radiotherapy with
vs without hyperthermia .
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
participating center, disease stage (IIB or IIIA vs IIIB or IVA) and age (< 60 years vs ≥ 60
years). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive cisplatin IV and concurrently undergo hyperthermia over 60-90
minutes on day 1. Patients also undergo external beam radiotherapy once daily on days
1-5. Treatment repeats weekly for 5-6 weeks in the absence of disease progression or
unacceptable toxicity. After completion of chemoradiotherapy and hyperthermia, patients
undergo brachytherapy to the cervix for 2-3 days.
- Arm II: Patients receive cisplatin and undergo radiotherapy (including brachytherapy)
as in arm I.
Patients are followed at 4-6 weeks, every 3 months for 2 years, every 6 months for 5 years,
and then annually thereafter.
PROJECTED ACCRUAL: A total of 400 patients (200 per treatment arm) will be accrued for this
study within 5 years.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
r Primary tumor response rate at 4-6 weeks post treatment
3 months from start of therapy
Ellen L. Jones, MD, PhD
Duke Cancer Institute
United States: Food and Drug Administration
|Duke Comprehensive Cancer Center||Durham, North Carolina 27710|
|Robert H. Lurie Comprehensive Cancer Center at Northwestern University||Chicago, Illinois 60611|