Reis Fihlo 2018.

Study name	The final results will be available in 2023 (personal communication with the authors).
Methods	Abstract only RCT Not possible to define if single or multicentre trial.
Participants	Disease characteristics: women aged ≥ 18 years with invasive squamous cell carcinoma of the cervix; FIGO Stage IB2, IIA or IIB; ECOG Performance Status 0–1 and adequate organ function are required.
Interventions	244 women will be randomly assigned to 1 of 2 arms. CCRT Standard chemoradiotherapy (cisplatin 40 mg/m2 intravenously: days 1, 8, 15, 29 and 36 concurrent with external radiotherapy 50.4 Gy fractionated in 28 sessions of 1.8 Gy followed by brachytherapy in 4 insertions of 7 Gy). NACT and radical hysterectomy Intravenous NACT (cisplatin 75 mg/m2 day 1 + paclitaxel 80 mg/m2) day 1, 8 and 15 of each 21 days for 3 cycles. After each cycle, the participant will be evaluated to verify toxicity and tumour response. After the third cycle, the participants with a complete clinical response or substantial tumour reduction (tumour restricted to cervix 4 cm), confirmed by pelvic MRI will undergo Piver‐Rutledge class III abdominal hysterectomy and pelvic lymphadenectomy 3–6 weeks after the last cycle. Participants with tumour progression or severe toxicity after any cycle of NACT or with inoperable tumour after the third cycle of NACT will be treated with definitive standard chemoradiotherapy.
Outcomes	Primary endpoint 5‐year overall survival Secondary endpoints Disease‐free survival Rate of operability (in the NACT + radical hysterectomy arm) Complete pathological response (in the NACT + radical hysterectomy arm)
Starting date
Contact information
Notes	No results to date. Clinical Trial Identification UTN: U1111‐1213‐5169