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

Last updated: December 4, 2024
Sponsor: University College, London
Overall Status: Active - Not Recruiting

Phase

3

Condition

Cervical Cancer

Vaginal Cancer

Pelvic Cancer

Treatment

Radiotherapy

Cisplatin

Paclitaxel

Clinical Study ID

NCT01566240
UCL 11/0034
C37815/A12832
2011-001300-35
  • Ages > 18
  • Female

Study Summary

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.

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

Total Participants: 500
Treatment Group(s): 4
Primary Treatment: Radiotherapy
Phase: 3
Study Start date:
November 08, 2012
Estimated Completion Date:
December 31, 2026

Connect with a study center

  • Instituto do Câncer do Estado de São Paulo

    São Paulo, 01246-000
    Brazil

    Site Not Available

  • Chittaranjan National Cancer Institute (CNCI)

    Kolkata,
    India

    Site Not Available

  • Saroj Gupta Cancer Centre and Research Institute

    Kolkata,
    India

    Site Not Available

  • Istituto Europeo di Oncologia

    Milan, Lombardy 20141
    Italy

    Site Not Available

  • Instituto Nacional de Cancerologia (INCAN)

    Mexico City,
    Mexico

    Site Not Available

  • North Devon District Hospital

    Barnstaple, Devon EX31 4JB
    United Kingdom

    Site Not Available

  • University College London Hospital

    London, Greater London NW1 2BU
    United Kingdom

    Site Not Available

  • Weston Park Hospital

    Sheffield, South Yorkshire S10 2SJ
    United Kingdom

    Site Not Available

  • Belfast City Hospital

    Belfast,
    United Kingdom

    Site Not Available

  • Pilgrim Hospital

    Boston,
    United Kingdom

    Site Not Available

  • Royal Sussex County Hospital

    Brighton,
    United Kingdom

    Site Not Available

  • Velindre Cancer Centre

    Cardiff,
    United Kingdom

    Site Not Available

  • Cheltenham General Hospital

    Cheltenham,
    United Kingdom

    Site Not Available

  • Royal Derby Hospital

    Derby,
    United Kingdom

    Site Not Available

  • Royal Devon and Exeter NHS Foundation Trust

    Exeter, EX2 5DY
    United Kingdom

    Site Not Available

  • Beatson WOSCC

    Glasgow,
    United Kingdom

    Site Not Available

  • Gloucester Royal Hospital

    Gloucester,
    United Kingdom

    Site Not Available

  • Grantham and District Hospital

    Grantham,
    United Kingdom

    Site Not Available

  • Castle Hill Hospital

    Hull,
    United Kingdom

    Site Not Available

  • St James University Hospital

    Leeds, LS9 7TF
    United Kingdom

    Site Not Available

  • Leicester Royal Infirmary

    Leicester,
    United Kingdom

    Site Not Available

  • Lincoln County Hospital

    Lincoln,
    United Kingdom

    Site Not Available

  • Guy's and St Thomas' NHS Foundation Trust

    London,
    United Kingdom

    Site Not Available

  • Imperial College Healthcare NHS Trust

    London,
    United Kingdom

    Site Not Available

  • St Bart's Hospital

    London,
    United Kingdom

    Site Not Available

  • The Christie NHS Foundation Trust

    Manchester, M20 4BX
    United Kingdom

    Site Not Available

  • James Cook University Hospital

    Middlesborough, TS4 3BW
    United Kingdom

    Site Not Available

  • James Cook University Hospital

    Middlesbrough,
    United Kingdom

    Site Not Available

  • Milton Keynes Hospital NHS Foundation Trust

    Milton Keynes, MK6 5LD
    United Kingdom

    Site Not Available

  • Freeman Hospital

    Newcastle,
    United Kingdom

    Site Not Available

  • Norfolk and Norwich University Hospital

    Norfolk,
    United Kingdom

    Site Not Available

  • Northampton General Hospital

    Northampton,
    United Kingdom

    Site Not Available

  • Norfolk and Norwich University Hospital

    Norwich,
    United Kingdom

    Site Not Available

  • Nottingham University Hospitals NHS Trust

    Nottingham, NG5 1PB
    United Kingdom

    Site Not Available

  • Derriford Hospital

    Plymouth,
    United Kingdom

    Site Not Available

  • Poole Hospital NHS Foundation Trust

    Poole, BH15 2JB
    United Kingdom

    Site Not Available

  • Queens Hospital

    Romford, RM7 0AG
    United Kingdom

    Site Not Available

  • Royal Shrewsbury Hospital

    Shrewsbury,
    United Kingdom

    Site Not Available

  • Southampton General Hospital

    Southampton,
    United Kingdom

    Site Not Available

  • Royal Stoke University Hospital

    Stoke-On-Trent,
    United Kingdom

    Site Not Available

  • Great Western Hospitals NHS Foundation Trust

    Swindon, SN3 6BB
    United Kingdom

    Site Not Available

  • Torbay Hospital

    Torquay,
    United Kingdom

    Site Not Available

  • Royal Cornwall Hospital

    Truro,
    United Kingdom

    Site Not Available

  • The Clatterbridge Cancer Centre

    Wirral,
    United Kingdom

    Site Not Available

  • New Cross Hospital

    Wolverhampton,
    United Kingdom

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.