A Phase III Multicentre Trial of Weekly Induction Chemotherapy Followed by Standard Chemoradiation Versus Standard Chemoradiation Alone in Patients With Locally Advanced Cervical Cancer
Inclusion Criteria:
- Histologically confirmed FIGO stage Ib2-IVa squamous, adeno or adenosquamous
carcinoma of the cervix (except FIGO IIIA)
- 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)
- Capable of providing written or witnessed informed consent
Patients with positive 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*
- Involvement of lower 1/3 vagina (FIGO IIIA disease)
- 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
- Documented positive HIV antibody test or HIV viral load (patients recruited from high
risk countries or who have moved within the past 10 years from high risk countries)
- Active TB
- 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