Phase
Condition
Cervical Cancer
Vaginal Cancer
Pelvic Cancer
Treatment
Radiotherapy
Cisplatin
Paclitaxel
Clinical Study ID
Ages > 18 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Histologically confirmed FIGO stage Ib2-IVa squamous, adeno or adenosquamouscarcinoma of the cervix (except FIGO IIIA). Patients with histologically confirmedFIGO 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 Wrightequation (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 whohave 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
Exclusion Criteria:
Previous pelvic malignancy (regardless of interval since diagnosis)
Previous malignancy not affecting the pelvis (except basal cell carcinoma of theskin) 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 wherethe 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 precludehydration during cisplatin administration and any contraindication to paclitaxel)
Pregnant or lactating * i.e. PET any size, CT/MRI ≥ 15mm
Study Design
Connect with a study center
Instituto do Câncer do Estado de São Paulo
São Paulo, 01246-000
BrazilSite Not Available
Chittaranjan National Cancer Institute (CNCI)
Kolkata,
IndiaSite Not Available
Saroj Gupta Cancer Centre and Research Institute
Kolkata,
IndiaSite Not Available
Istituto Europeo di Oncologia
Milan, Lombardy 20141
ItalySite Not Available
Instituto Nacional de Cancerologia (INCAN)
Mexico City,
MexicoSite Not Available
North Devon District Hospital
Barnstaple, Devon EX31 4JB
United KingdomSite Not Available
University College London Hospital
London, Greater London NW1 2BU
United KingdomSite Not Available
Weston Park Hospital
Sheffield, South Yorkshire S10 2SJ
United KingdomSite Not Available
Belfast City Hospital
Belfast,
United KingdomSite Not Available
Pilgrim Hospital
Boston,
United KingdomSite Not Available
Royal Sussex County Hospital
Brighton,
United KingdomSite Not Available
Velindre Cancer Centre
Cardiff,
United KingdomSite Not Available
Cheltenham General Hospital
Cheltenham,
United KingdomSite Not Available
Royal Derby Hospital
Derby,
United KingdomSite Not Available
Royal Devon and Exeter NHS Foundation Trust
Exeter, EX2 5DY
United KingdomSite Not Available
Beatson WOSCC
Glasgow,
United KingdomSite Not Available
Gloucester Royal Hospital
Gloucester,
United KingdomSite Not Available
Grantham and District Hospital
Grantham,
United KingdomSite Not Available
Castle Hill Hospital
Hull,
United KingdomSite Not Available
St James University Hospital
Leeds, LS9 7TF
United KingdomSite Not Available
Leicester Royal Infirmary
Leicester,
United KingdomSite Not Available
Lincoln County Hospital
Lincoln,
United KingdomSite Not Available
Guy's and St Thomas' NHS Foundation Trust
London,
United KingdomSite Not Available
Imperial College Healthcare NHS Trust
London,
United KingdomSite Not Available
St Bart's Hospital
London,
United KingdomSite Not Available
The Christie NHS Foundation Trust
Manchester, M20 4BX
United KingdomSite Not Available
James Cook University Hospital
Middlesborough, TS4 3BW
United KingdomSite Not Available
James Cook University Hospital
Middlesbrough,
United KingdomSite Not Available
Milton Keynes Hospital NHS Foundation Trust
Milton Keynes, MK6 5LD
United KingdomSite Not Available
Freeman Hospital
Newcastle,
United KingdomSite Not Available
Norfolk and Norwich University Hospital
Norfolk,
United KingdomSite Not Available
Northampton General Hospital
Northampton,
United KingdomSite Not Available
Norfolk and Norwich University Hospital
Norwich,
United KingdomSite Not Available
Nottingham University Hospitals NHS Trust
Nottingham, NG5 1PB
United KingdomSite Not Available
Derriford Hospital
Plymouth,
United KingdomSite Not Available
Poole Hospital NHS Foundation Trust
Poole, BH15 2JB
United KingdomSite Not Available
Queens Hospital
Romford, RM7 0AG
United KingdomSite Not Available
Royal Shrewsbury Hospital
Shrewsbury,
United KingdomSite Not Available
Southampton General Hospital
Southampton,
United KingdomSite Not Available
Royal Stoke University Hospital
Stoke-On-Trent,
United KingdomSite Not Available
Great Western Hospitals NHS Foundation Trust
Swindon, SN3 6BB
United KingdomSite Not Available
Torbay Hospital
Torquay,
United KingdomSite Not Available
Royal Cornwall Hospital
Truro,
United KingdomSite Not Available
The Clatterbridge Cancer Centre
Wirral,
United KingdomSite Not Available
New Cross Hospital
Wolverhampton,
United KingdomSite Not Available
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