A Phase II Randomized Study of Prophylactic Irradiation of the Para-Aortic Lymph Nodes by 3-D Conformal Radiotherapy Technique With Concurrent Chemotherapy Based on the Hypoxic Status of Locally Advanced Uterine Cervical Cancer
Patients with primary, untreated, histologically confirmed carcinoma of the uterine cervix
are included in this study. Absence of metastatic para-aortic lymphadenopathy is the
prerequisite of the enrollment, and this is confirmed by imaging studies such as MRI
covering the abdomen and pelvis, and PET/CT scan. The sample size is based on the previous
studies (1-3). Considering that the disease-free survival of the experimental arm (patients
who are treated with prophylactic para-aortic LN irradiation) and those who are not treated
is 82% vs 72% (preliminary analysis), with the alpha error of 5% and statistical power of
90% (one-sided), a total of 140 patients in each treatment arm is needed. With 10% of
follow-up loss taken into account, the total number of patients will be 312. Above figures
were calculated on the basis of 80% statistical power and 5% type I error rate. PAN is
treated prophylactically in the experimental arm with 45Gy/25F/5week fractionation schedule.
Pelvis is treated according to the individual institute's practice guideline. Boost
treatment for any enlarged pelvic lymph node or residual cervical/ parametrial disease with
conformal radiation technique are allowed. Intracavitary radiation is given via
low-dose-rate or high-dose-rate brachytherapy technique. Weekly cisplatin is given to all
patients, however, when the patient's physical condition does not allow cisplatin
administration, it can be omitted. This should be taken into account in the final analysis.
The stage and the presence of pelvic lymphadenopathy are two stratification factors.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
To evaluate the efficacy of the Extended-Field Irradiation on the recurrence rate in para-aortic lymph nodes and the disease-free survival rate of the patients with locally advanced uterine cervical cancer
Korea: Institutional Review Board