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

NCT ID: NCT01566240

Last Updated: 2024-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-08

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cervical Cancer

Keywords

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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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Chemoradiation

Radiotherapy (external beam and brachytherapy) plus concurrent Cisplatin weekly for 5 weeks

Group Type ACTIVE_COMPARATOR

Radiotherapy

Intervention Type RADIATION

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

Cisplatin

Intervention Type DRUG

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.

Induction Chemotherapy + Chemoradiation

6 cycles of weekly Paclitaxel and Carboplatin followed by Chemoradiation as per Active Comparator

Group Type EXPERIMENTAL

Paclitaxel

Intervention Type DRUG

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

Carboplatin

Intervention Type DRUG

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

Radiotherapy

Intervention Type RADIATION

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

Cisplatin

Intervention Type DRUG

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.

Interventions

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Paclitaxel

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

Intervention Type DRUG

Carboplatin

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

Intervention Type DRUG

Radiotherapy

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

Intervention Type RADIATION

Cisplatin

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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

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
* 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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Cancer Research UK

OTHER

Sponsor Role collaborator

University College, London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mary Dr McCormack, MBBS, FRCR

Role: PRINCIPAL_INVESTIGATOR

University College London Hospitals

Locations

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Instituto do Câncer do Estado de São Paulo

São Paulo, , Brazil

Site Status

Chittaranjan National Cancer Institute (CNCI)

Kolkata, , India

Site Status

Saroj Gupta Cancer Centre and Research Institute

Kolkata, , India

Site Status

Istituto Europeo di Oncologia

Milan, Lombardy, Italy

Site Status

Instituto Nacional de Cancerologia (INCAN)

Mexico City, , Mexico

Site Status

North Devon District Hospital

Barnstaple, Devon, United Kingdom

Site Status

University College London Hospital

London, Greater London, United Kingdom

Site Status

Weston Park Hospital

Sheffield, South Yorkshire, United Kingdom

Site Status

Belfast City Hospital

Belfast, , United Kingdom

Site Status

Pilgrim Hospital

Boston, , United Kingdom

Site Status

Royal Sussex County Hospital

Brighton, , United Kingdom

Site Status

Velindre Cancer Centre

Cardiff, , United Kingdom

Site Status

Cheltenham General Hospital

Cheltenham, , United Kingdom

Site Status

Royal Derby Hospital

Derby, , United Kingdom

Site Status

Royal Devon and Exeter NHS Foundation Trust

Exeter, , United Kingdom

Site Status

Beatson WOSCC

Glasgow, , United Kingdom

Site Status

Gloucester Royal Hospital

Gloucester, , United Kingdom

Site Status

Grantham and District Hospital

Grantham, , United Kingdom

Site Status

Castle Hill Hospital

Hull, , United Kingdom

Site Status

Leicester Royal Infirmary

Leicester, , United Kingdom

Site Status

Lincoln County Hospital

Lincoln, , United Kingdom

Site Status

Guy's and St Thomas' NHS Foundation Trust

London, , United Kingdom

Site Status

Imperial College Healthcare NHS Trust

London, , United Kingdom

Site Status

St Bart's Hospital

London, , United Kingdom

Site Status

The Christie NHS Foundation Trust

Manchester, , United Kingdom

Site Status

The Clatterbridge Cancer Centre

Metropolitan Borough of Wirral, , United Kingdom

Site Status

James Cook University Hospital

Middlesbrough, , United Kingdom

Site Status

Northampton General Hospital

Northampton, , United Kingdom

Site Status

Norfolk and Norwich University Hospital

Norwich, , United Kingdom

Site Status

Nottingham University Hospitals NHS Trust

Nottingham, , United Kingdom

Site Status

Derriford Hospital

Plymouth, , United Kingdom

Site Status

Southampton General Hospital

Southampton, , United Kingdom

Site Status

Royal Stoke University Hospital

Stoke-on-Trent, , United Kingdom

Site Status

Royal Cornwall Hospital

Truro, , United Kingdom

Site Status

New Cross Hospital

Wolverhampton, , United Kingdom

Site Status

Countries

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Brazil India Italy Mexico United Kingdom

References

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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.

Reference Type DERIVED
PMID: 39419054 (View on PubMed)

Other Identifiers

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2011-001300-35

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

C37815/A12832

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

UCL 11/0034

Identifier Type: -

Identifier Source: org_study_id