To compare 5-year overall survival between patients who undergo radical hysterectomy followed by tailored adjuvant therapy and patients who receive primary chemoradiation therapy in FIGO stage IB2 and IIA2 cervical cancer
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
409
Piver-Rutledge type III hysterectomy New classification type C2 hysterectomy Open, vaginal, laparoscopic assisted, laparoscopic, robotic radical hysterectomy are all allowed
After radical hysterectomy, intermediate risk group according to GOG protocol 92 criteria will receive adjuvant radiation therapy. High risk group will receive adjuvant chemoradiation therapy with weekly cisplatin (40mg/m2, IV for 6 cycles). Extended filed radiation therapy is allowed in case of common iliac lymph node or para-aortic lymph node metastasis. Intracavitary brachytherapy and nodal or parametrial boost is not allowed.
Patient will receive primary radiation therapy including external pelvic irradiation, intracavitary brachytherapy, and parametrial or nodal boost. Extended filed radiation therapy is allowed in case of common iliac lymph node enlargement. Patients will receive concurrent weekly cisplatin (cisplatin 40mg/m2 for 6 cycles) during external radiation therapy.
Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center
Seoul, South Korea
RECRUITING5-year overall survival
Time frame: 5 year after treatment
5-year progression-free survival
Time frame: 5 years after treatment
Pattern of disease recurrence
Time frame: within 5 years afer treatment
Treatment-related toxicity
Treatment related toxicity will be evaluated using CTCAE v3.0.
Time frame: within 5 years after treatment
Quality of life
Time frame: within 1 year after treatment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.