162 Neoadjuvant chemotherapy followed by radical surgery versus chemoradiation for stage IB2, IIA2 and IIB cervical cancer: an open-label, phase III, randomized controlled trial

Objectives Chemoradiation (CHR) is the standard treatment for inoperable cervical cancer (CC). Neoadjuvant chemotherapy (NCT) plus radical surgery might be advantageous according to previous trials. The aims of this RCT are to access efficacy and tolerability of this experimental treatment. Primary end point is 5y OS. Secondary endpoints include: disease free survival, operability rate and complete pathological response rate. Methods Women diagnosed with invasive CC stages IB2, IIA or IIB will be randomized to: Experimental arm: NCT (cisplatin 75 mg/m2 (D1) plus paclitaxel 80 mg/m2 (D1, D8 and D15), each 21 days, 3 cycles) or Control ARM: CHR (cisplatin 40 mg/m2 (D1, D8, D15, D21 and D28) in concomitancy with external radiation 50.4Gy (28 x 1,8Gy) followed by brachytherapy (4 x 7Gy). The patients who reach Complete clinical response or substantial tumour reduction after NCT ( restricted to cervix ≤4 cm) are going to be submitted to Piver-Rutledge class III abdominal hysterectomy and pelvic lymphadenectomy, 3–6 weeks after the last cycle. Progressive Disease, severe toxicity or inoperable tumour after NCT will be conducted to Definitive standard CHR. Results Eleven patients have been recruited. The Median age of the patients was 39.5 years. NCT plus radical surgery was completed in four patients and alterations in chemotherapy schedule were not necessary. All patients in the NCT arm became operable. Two patients in the CHR arm had the treatment delayed. Conclusions NCT is well tolerated with signs of high activity in cervical cancer. The CHR schedule seems more prone to suffer delays.