Clinical Research Directory

Inclusion Criteria: * Histologically confirmed FIGO stage Ib2-IVa squamous, adeno or adenosquamous carcinoma of the cervix (except FIGO IIIA). Patients with histologically confirmed FIGO stage IB1 and positive lymph nodes are also eligible * Deemed suitable and fit for radical chemoradiation * Medically fit to receive carboplatin and paclitaxel * ECOG performance status 0 - 1 * No evidence of active TB * Aged 18 and over * Adequate renal function, defined as a GFR ≥ 60 ml/min calculated using the Wright equation (or ≥ 50 ml/min for radioisotope GFR assessment) * Adequate liver function, as defined by ALT or AST \< 2.5 ULN and bilirubin \< 1.25 ULN * Adequate bone marrow function as defined by ANC ≥1.5 x 109/L, platelets ≥ 100 x 109/L * Using adequate contraception precautions if relevant * A documented negative HIV test (patients recruited from high risk countries or who have moved within the past 10 years from high risk countries) * A documented negative pregnancy test (if applicable) * Capable of providing written or witnessed informed consent Patients with positive (pelvic/para-aortic/both) nodes (either histologically/PET positive ≥15 mm on CT/MRI) at or below the level of the aortic bifurcation may be included in the study provided none of the exclusion criteria apply. Exclusion Criteria: * Previous pelvic malignancy (regardless of interval since diagnosis) * Previous malignancy not affecting the pelvis (except basal cell carcinoma of the skin) where disease free interval is less than 10 years * Positive lymph nodes (imaging or histological) above the aortic bifurcation\* * Hydronephrosis which has not undergone ureteric stenting or nephrostomy except where the affected kidney is non-functioning * Evidence of distant metastasis i.e. any non-nodal metastasis beyond the pelvis * Previous pelvic radiotherapy * Prior diagnosis of Crohn's disease or Ulcerative colitis * Uncontrolled cardiac disease (defined as cardiac function which would preclude hydration during cisplatin administration and any contraindication to paclitaxel) * Pregnant or lactating \* i.e. PET any size, CT/MRI ≥ 15mm