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Cervical CancerPhase 3INTERLACENCT01566240

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

A Phase 3 study testing Paclitaxel, Carboplatin and Radiotherapy in people with Cervical Cancer, run by University College, London at 35 sites in 5 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Cervical Cancer
What is being tested?
Paclitaxel, Carboplatin and Radiotherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
500 participants
Where
35 sitesin 5 countries
Study dates
8 Nov 2012to Dec 2026
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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
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  • Prior diagnosis of Crohn's disease or Ulcerative colitis
  • 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

Trial locations and contacts

35 sites in 5 countries.

35 sites in 5 countries

United Kingdom30 sites

  • North Devon District Hospital

    Barnstaple, Devon, EX31 4JB

  • Belfast City Hospital

    Belfast

  • Pilgrim Hospital

    Boston

  • Royal Sussex County Hospital

    Brighton

  • Velindre Cancer Centre

    Cardiff

  • Cheltenham General Hospital

    Cheltenham

  • Royal Derby Hospital

    Derby

  • Royal Devon and Exeter NHS Foundation Trust

    Exeter, EX2 5DY

  • Beatson WOSCC

    Glasgow

  • Gloucester Royal Hospital

    Gloucester

  • Grantham and District Hospital

    Grantham

  • Castle Hill Hospital

    Hull

  • Leicester Royal Infirmary

    Leicester

  • Lincoln County Hospital

    Lincoln

  • University College London Hospital

    London, Greater London, NW1 2BU

  • Guy's and St Thomas' NHS Foundation Trust

    London

  • Imperial College Healthcare NHS Trust

    London

  • St Bart's Hospital

    London

  • The Christie NHS Foundation Trust

    Manchester, M20 4BX

  • The Clatterbridge Cancer Centre

    Metropolitan Borough of Wirral

  • James Cook University Hospital

    Middlesbrough

  • Northampton General Hospital

    Northampton

  • Norfolk and Norwich University Hospital

    Norwich

  • Nottingham University Hospitals NHS Trust

    Nottingham, NG5 1PB

  • Derriford Hospital

    Plymouth

  • Weston Park Hospital

    Sheffield, South Yorkshire, S10 2SJ

  • Southampton General Hospital

    Southampton

  • Royal Stoke University Hospital

    Stoke-on-Trent

  • Royal Cornwall Hospital

    Truro

  • New Cross Hospital

    Wolverhampton

Other trials in United Kingdom

India2 sites

  • Chittaranjan National Cancer Institute (CNCI)

    Kolkata

  • Saroj Gupta Cancer Centre and Research Institute

    Kolkata

Other trials in India

Brazil1 site

  • Instituto do Câncer do Estado de São Paulo

    São Paulo, 01246-000

Other trials in Brazil

Italy1 site

  • Istituto Europeo di Oncologia

    Milan, Lombardy, 20141

Other trials in Italy

Mexico1 site

  • Instituto Nacional de Cancerologia (INCAN)

    Mexico City

Other trials in Mexico

About this study

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

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.

Conditions
Cervical Cancer
Being tested
Paclitaxel, Carboplatin, Radiotherapy, Cisplatin
Keywords
Cervical Cancer, Chemotherapy, Paclitaxel, Carboplatin, Cisplatin, Radiotherapy, Chemoradiation, Brachytherapy, Stage IB2 Cervical Cancer, Stage IIA Cervical Cancer, Stage IIB Cervical Cancer, Stage IIIB Cervical Cancer, Stage IVA Cervical Cancer
Medical subject headings
Uterine Cervical Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PaclitaxelDrug

    Paclitaxel 80 mg/m2 (capped at 162mg maximum total dose) weekly for 6 weeks i.e. on days 1, 8, 15, 22, 29 \& 36.

  • CarboplatinDrug

    Carboplatin AUC 2 (capped at 270mg maximum total dose) weekly for 6 weeks i.e. on day 1, 8, 15, 22, 29, \& 36.

  • RadiotherapyRadiation

    Radiotherapy comprising external beam 40-50.4Gy in 20-28 fractions plus intracavity brachytherapy to achieve a minimum total EQD2 dose of 78-86Gy.

  • CisplatinDrug

    Cisplatin 40 mg/m2 (capped at 70mg total dose) weekly for five weeks maximum, commencing in the first week of radiotherapy or as soon as blood counts have recovered from induction chemotherapy.

Study groups in NCT01566240
Study groupRoleWhat they receive
ChemoradiationActive comparatorRadiotherapy (external beam and brachytherapy) plus concurrent Cisplatin weekly for 5 weeks
Receives: Radiation: Radiotherapy; Drug: Cisplatin
Induction Chemotherapy + ChemoradiationExperimental6 cycles of weekly Paclitaxel and Carboplatin followed by Chemoradiation as per Active Comparator
Receives: Drug: Paclitaxel; Drug: Carboplatin; Radiation: Radiotherapy; Drug: Cisplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival

    Measured: 5 years

Secondary outcomes (4)

  1. Progression free survival

    Measured: 12 weeks post treatment and then as required

  2. Adverse events (AE) as assessed by the Common Terminology Criteria for Adverse Events v4.03

    Measured: To be assessed at every timepoint i.e. baseline; at every chemotherapy cycle, at all follow up visits.

  3. Quality of Life (UK and Ireland only) as assessed by EORTC QLQ-C30, QLQ-CX24 and EQ-5D

    Measured: Baseline, during induction chemotherapy (Week 4), day 1 of chemoradiation, during chemoradiation (Weeks 3), 4 weeks post end of treatment, and as part of follow up (3 monthly for 2 years; 6 monthly for 3 years until 5 years post randomisation)

  4. Patterns of first relapse (local and/or systemic)

    Measured: 12 weeks post treatment and as required

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Mar 2012 (estimated)
  2. Study start8 Nov 2012
  3. Primary completionFeb 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
500 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01566240
Sponsor's protocol ID
UCL 11/0034
Other IDs
2011-001300-35, C37815/A12832
Acronym
INTERLACE
Status last verified
Dec 2024
First submitted
27 Mar 2012
Last updated
5 Dec 2024
Results posted
No
Data monitoring committee
No

Publications

  • McCormack M, Eminowicz G, Gallardo D, Diez P, Farrelly L, Kent C, Hudson E, Panades M, Mathew T, Anand A, Persic M, Forrest J, Bhana R, Reed N, Drake A, Adusumalli M, Mukhopadhyay A, King M, Whitmarsh K, McGrane J, Colombo N, Mak C, Mandal R, Chowdhury RR, Alamilla-Garcia G, Chavez-Blanco A, Stobart H, Feeney A, Vaja S, Hacker AM, Hackshaw A, Ledermann JA; INTERLACE investigators. Induction chemotherapy followed by standard chemoradiotherapy versus standard chemoradiotherapy alone in patients with locally advanced cervical cancer (GCIG INTERLACE): an international, multicentre, randomised phase 3 trial. Lancet. 2024 Oct 19;404(10462):1525-1535. doi: 10.1016/S0140-6736(24)01438-7. Epub 2024 Oct 14.

    PubMed 39419054

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Paclitaxel, Carboplatin and Radiotherapy in people with Cervical Cancer, run by University College, London at 35 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 5 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 sites in United Kingdom, India, Brazil, Italy, Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01566240, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2024.

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