Uterine cervix cancer can be treated definitively with concurrent chemoradiation (external beam radiotherapy and chemotherapy) followed by high dose rate brachytherapy. Treatment duration can be shortened by increasing the dose per fraction of treatment which can reduce costs and patient exposure. The aim of our study is to determine the non-inferiority of hypofractionated radiotherapy compared with conventional treatment.
Pathology of squamous cell carcinoma (SCC), adenocarcinoma, adenosquamous carcinoma of uterine cervix- International Federation of Gynecology and Obstetrics (FIGO) stage IB, IIA, IIB, IIIA, IIIB (due to hydronephrosis without creatinine clearance compromise), IIIC1 (if less than 3 lymph nodes with size less than 3cm, and without involvement of common iliac chain)- Patient eligible for definitive chemoradiotherapy followed by brachytherapy
Creatinine clearance less than 30ml/min, any histology other than the above, requirement of paraaortic lymph node irradiation, inflammatory bowel disease, connective tissue disorders, previous pelvic radiotherapy, FIGO stage IA or IV, Eastern Cooperative Oncology Group (ECOG) performance status greater than 2, History of previous hysterectomy
Parallel
Hypofractionated EBRT
RadiationEBRT dose of 40Gy in 15 fractions over 3 weeks plus 3 weekly infusions of cisplatin 40mg/m2
Standard EBRT
RadiationEBRT dose of 45Gy in 25 fractions over 5 weeks plus 5 weekly infusions of cisplatin 40mg/m2
Early toxicity
Early treatment-related toxicity within 3 months after completion of treatment as defined by CTCAE 5.0.
Early response
Early response to treatment at 3 months after treatment completion based on dynamic contrast-enhanced pelvic MRI findings
Late toxicity
Late treatment-related toxicity within 1 and 3 years after completion of treatment as defined by CTCAE 5.0.
Progression-free survival
Time from randomization to progression(based on MRI and physical examination), death, or last follow up; whichever that occurs first
Disease-specific survival
Time from randomization to death from cervical cancer or last follow-up; whichever that occurs first.
Overall survival
Time from randomization to death from any reason or last follow-up; whichever that occurs first.
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