A Phase III trial of adjuvant chemotherapy following chemo-radiation as primary treatment for locally advanced cervical cancer compared to chemo-radiation alone: The OUTBACK Trial

Study Design: An international, prospective, multi-centre, randomised, phase III GCIG trial led by ANZGOG, in collaboration with the GOG, RTOG and India. Patient population: Patients with stage IB1 & positive nodes, IB2, II, IIIB or IVA cervical cancer suitable for primary treatment with chemo-radiation with curative intent. Intervention: Radiotherapy regimen: All patients (Arm A and B) will receive 45 – 50.4 Gy external beam radiation therapy (EBRT) delivered in fractions of 1.8 Gy to the pelvis, followed by brachytherapy. Chemotherapy regimen: Cisplatin will be given during the radiation at a dose of 40mg/m2 weekly for 5 doses to all patients (Arm A and B). Within 4 weeks of completion of all radiation treatment, and following recovery from toxicities, patients in Arm B will be treated with an additional 4 cycles of 3 weekly adjuvant chemotherapy using carboplatin AUC 5 and paclitaxel 155 mg/m2. Primary Objective: To determine if the addition of adjuvant chemotherapy to standard cisplatinbased chemo-radiation improves overall survival. Secondary objectives: To determine: progression-free survival rates, acute and long-term toxicities, patterns of disease recurrence, the association between radiation protocol compliance and outcomes and patient quality of life, including psycho-sexual health.