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NCT01566240Active, not recruitingPhase 3

Induction Chemotherapy Plus Chemoradiation as First Line Treatment for Locally Advanced Cervical Cancer

A Phase III Multicentre Trial of Weekly Induction Chemotherapy Followed by Standard Chemoradiation Versus Standard Chemoradiation Alone in Patients With Locally Advanced Cervical Cancer

Source: ClinicalTrials.gov · Last updated 5 Dec 2024

Brief summary (registry, in English)

Chemoradiation has been the standard treatment for advanced cervical cancer for a decade, but one third of women still die from a failure to control systemic disease. In a recent multicentre phase II trial of 46 women the investigators found that, 68% of women had tumours that responded to weekly induction chemotherapy prior to chemoradiation. The induction chemotherapy had acceptable toxicity and did not compromise the standard chemoradiation treatment. In addition, the overall survival and progression free survival at 3 years was 66% (95% CI 4779). These results, together with acceptable toxicity, provide justification for evaluating induction chemotherapy prior to chemoradiation in a randomised phase III trial. The investigators aim to investigate in a randomised trial whether additional induction chemotherapy given on a weekly schedule immediately before standard chemoradiation leads to an improvement in overall survival. The investigators plan to recruit 770 women with locally advanced cervical cancer who are eligible for standard chemoradiation, they will be randomised to weekly carboplatin and paclitaxel chemotherapy for 6 weeks followed by chemoradiation or to chemoradiation alone. The trial will recruit for 4 years with 5 years of follow up period.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
500 (actual)
First submitted
27 Mar 2012
Start date
8 Nov 2012
Primary completion date
Feb 2026
Lead sponsor
University College, London
NCT number
NCT01566240
EudraCT number
2011-001300-35

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 500
  • From 8 Nov 2012 to the primary completion date, Feb 2026
  • 35 sites in 5 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous pelvic malignancy (regardless of interval since diagnosis)
  • Previous pelvic radiotherapy
  • Prior diagnosis of Crohn's disease or Ulcerative colitis

Other illness

  • Previous malignancy not affecting the pelvis (except basal cell carcinoma of the skin) where disease free interval is less than 10 years
  • Uncontrolled cardiac disease (defined as cardiac function which would preclude hydration during cisplatin administration and any contraindication to paclitaxel)

Other

  • 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
  • Pregnant or lactating \* i.e. PET any size, CT/MRI ≥ 15mm

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (35)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Instituto do Câncer do Estado de São Paulo
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São PauloBrazilUnknown status
North Devon District Hospital
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BarnstapleUnited KingdomUnknown status
Belfast City Hospital
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BelfastUnited KingdomUnknown status
Pilgrim Hospital
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BostonUnited KingdomUnknown status
Royal Sussex County Hospital
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BrightonUnited KingdomUnknown status
Velindre Cancer Centre
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CardiffUnited KingdomUnknown status
Cheltenham General Hospital
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CheltenhamUnited KingdomUnknown status
Royal Derby Hospital
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DerbyUnited KingdomUnknown status
Royal Devon and Exeter NHS Foundation Trust
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ExeterUnited KingdomUnknown status
Beatson WOSCC
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GlasgowUnited KingdomUnknown status
Gloucester Royal Hospital
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GloucesterUnited KingdomUnknown status
Grantham and District Hospital
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GranthamUnited KingdomUnknown status
Castle Hill Hospital
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HullUnited KingdomUnknown status
Leicester Royal Infirmary
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LeicesterUnited KingdomUnknown status
Lincoln County Hospital
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LincolnUnited KingdomUnknown status
Imperial College Healthcare NHS Trust
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LondonUnited KingdomUnknown status
University College London Hospital
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LondonUnited KingdomUnknown status
Guy's and St Thomas' NHS Foundation Trust
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LondonUnited KingdomUnknown status
St Bart's Hospital
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LondonUnited KingdomUnknown status
The Christie NHS Foundation Trust
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ManchesterUnited KingdomUnknown status
The Clatterbridge Cancer Centre
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Metropolitan Borough of WirralUnited KingdomUnknown status
James Cook University Hospital
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MiddlesbroughUnited KingdomUnknown status
Northampton General Hospital
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NorthamptonUnited KingdomUnknown status
Norfolk and Norwich University Hospital
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NorwichUnited KingdomUnknown status
Nottingham University Hospitals NHS Trust
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NottinghamUnited KingdomUnknown status
Derriford Hospital
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PlymouthUnited KingdomUnknown status
Weston Park Hospital
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SheffieldUnited KingdomUnknown status
Southampton General Hospital
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SouthamptonUnited KingdomUnknown status
Royal Stoke University Hospital
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Stoke-on-TrentUnited KingdomUnknown status
Royal Cornwall Hospital
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TruroUnited KingdomUnknown status
New Cross Hospital
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WolverhamptonUnited KingdomUnknown status
Chittaranjan National Cancer Institute (CNCI)
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KolkataIndiaUnknown status
Saroj Gupta Cancer Centre and Research Institute
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KolkataIndiaUnknown status
Istituto Europeo di Oncologia
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MilanItalyUnknown status
Instituto Nacional de Cancerología (INCan)
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Mexico CityMexicoUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.