Locally advanced cervical cancer MedDRA version: 21.1 Level: LLT Classification code 10008233 Term: Cervical cancer stage I System Organ Class: 100000004864 MedDRA version: 21.1 Level: LLT Classification code 10008234 Term: Cervical cancer stage II System Organ Class: 100000004864 MedDRA version: 21.1 L
Conditions
Interventions
Product Name: carboplatin
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: carboplatin
CAS Number: 41575-94-4
Concentrati
Sponsors
University College London
Eligibility
Sex/Gender
All
Inclusion criteria
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 chemoradition - 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 /=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/MR) at or below the level of the aortic bifurcation may be included in the study provided none of the exclusion criteria apply Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 435 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 65
Exclusion criteria
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 - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: In women with locally advanced cervical cancer, does the addition of weekly chemotherapy prior to chemoradiation alone improve overall survival compared with chemoradiation alone?; Secondary Objective: - In women with locally advanced cervical cancer, does the addition of weekly chemotherapy prior to chemoradiation alone improve disease free survival compared with chemoradiation alone? - What is the toxicity associated with the additional weekly chemotherapy treatment? - What are the effects on quality of life compared with the standard chemoradiation treatment? - Does the addition of weekly chemotherapy affect the pattern of relapse in this disease? ;Primary end point(s): The primary outcome measure is overall survival.;Timepoint(s) of evaluation of this end point: Overall survival will be measured from the date of randomisation until the date of death from any cause. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Progression free survival Adverse events Quality of life Patterns of relapse ; Timepoint(s) of evaluation of this end point: Progression free survival will be measured from the date of randomisation until the date of first progression or death, whichever occurs first. Adverse events will be collected weekly during treatment, 4 weeks post treatment, 3 monthly for 2 years and 6 monthly for 3 years. Quality of life will be collected during treatment and at follow-up visits as outlined above. Patterns of relapse (local and/or systemic) will be assessed during follow-up from the date of randomisation until the date of first relapse. | — |
Countries
Brazil, India, Italy, Mexico, United Kingdom
Contacts
Public ContactIoannis Nikolaou
Cancer Research UK & UCL Cancer Trials Centre
Outcome results
None listed