GOG 274: A PHASE III TRIAL OF ADJUVANT CHEMOTHERAPY AS PRIMARY TREATMENT FOR LOCALLY ADVANCED CERVICAL CANCER COMPARED TO CHEMORADIATION ALONE: THE OUTBACK TRIAL (ANZGOG 0902/GOG-0274/RTOG 1174)
The study design is an international, prospective, multi-centre, randomised, phase III GCIG trial led by Australia New Zealand Gynecologica Oncology Group (ANZGOG), in collaboration with the GOG, RTOG, NCIC CTG, NSGO, GEICO, Romania, India and Brazil.multi-centre randomised phase III trial.
Arm A: Standard chemoradiation
Arm B: Standard chemoradiation followed by 4 cycles of carboplatin and paclitaxel
Patients in both arms will be treated with standard external beam radiation treatment to the pelvis and
brachytherapy. Cisplatin will be given during the radiation at a dose of 40mg/m2 weekly for 5 doses.
Within 4 weeks of completion of all radiation treatment, including the brachytherapy component, and
following recovery from toxicities, patients in Arm B will be treated with 4 cycles of 3 weekly adjuvant
chemotherapy using carboplatin AUC 5 and paclitaxel 155 mg/m2.
Eligible patients will have locally advanced cervical cancer suitable for primary treatment with chemoradiation
with curative intent, in addition to:
*FIGO 2008 stage IB1 & node positive, IB2, II, IIIB or IVA disease.
*Age 18 years or older
* ECOG performance status 0 - 2
* Histological diagnosis of squamous cell carcinoma, adenocarcinoma or adenosquamous cell
carcinoma of the cervix
* WBC ≥ 3.0 x 109/L and ANC ≥ 1.5 x 109/L
* Platelets ≥ 100 x 109/L
* Bilirubin ≤ 1.5 x ULN
* AST/ALT ≤ 2.5 x ULN
* Adequate renal function: creatinine ≤ ULN (CTC Grade 0) or calculated creatinine clearance
(Cockcroft-Gault Formula) ≥ 60ml/min or ≥ 50 ml/min by EDTA creatinine clearance
* Written informed consent