Cisplatin Based Chemoradiation v.s Radiotherapy for Cervical Cancer and With Clinically Defined Good Prognosis
Status:
Unknown status
Trial end date:
2013-01-01
Target enrollment:
Participant gender:
Summary
This phase III study is designed to examine if low-risk, as defined by clinical and
radiological parameters, stage IB-IIB cervical cancer patients treated by cisplatin-based
chemoradiation, which is a recommended method by today's standard, have greater toxicities
but similar survival rate as those treated by radiotherapy (RT) alone. Patients will be
primarily treated with radiotherapy with same protocol, but without concurrent chemotherapy
in the control arm, and with weekly cisplatin (40 mg/M2) for 6 courses in the study arm. This
study will be conducted at all branches of Chang Gung Memorial Hospital except Chia-I.
Patients will be randomized to either arm after stratification of risk factors. Each arm will
recruit 104 patients who have no LN and systemic metastasis as defined by CT/MRI and FDG-PET.
The primary end point is grade 3-5 late toxicities, and secondary end points are 1)
recurrence free survival; 2) acute toxicity of treatments; 3) sites of recurrence; 4) quality
of life; 5) total treatment time. It is expected to take 5 years to recruit enough case
number.