Induction Chemotherapy Plus Chemoradiation as First Line Treatment for Loca... | Recruiting
Induction Chemotherapy Plus Chemora... | Recruiting
Induction Chemotherapy Plus Chemoradiation as First Line Treatment for Locally Advanced Cervical Cancer
INTERLACE

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Medical Conditions
  • Cervical Cancer
Primary Contact Details
Nicola McGowan
+44 207 679 9866
See all trial contact details
Recruitment Status
Recruiting
Trial source and source ID number
NCT01566240
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
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.
Research Details
    Sorry, this information is not available
Phase
Phase 3
Study Design
Sorry, this information is not available
Study Type
Interventional
Intervention
Drug : Paclitaxel, Drug : Carboplatin, Radiation : Radiotherapy, Drug : Cisplatin

Study Arm Groups : Induction Chemotherapy + Chemoradiation, Induction Chemotherapy + Chemoradiation, Chemoradiation, Induction Chemotherapy + Chemoradiation, Chemoradiation, Induction Chemotherapy + Chemoradiation

Intervention Type
See Interventions above
Primary Outcome Measures
    Overall Survival; 5 years
Secondary Outcome Measures
    Progression free survival; 12 weeks post treatment and then as required; Adverse events (AE) as assessed by the Common Terminology Criteria for Adverse Events v4.03; To be assessed at every timepoint i.e. baseline; at every chemotherapy cycle, at all follow up visits.; Quality of Life (UK and Ireland only) as assessed by EORTC QLQ-C30, QLQ-CX24 and EQ-5D; 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); Patterns of first relapse (local and/or systemic); 12 weeks post treatment and as required
Publication(s)
Sorry, this information is not available
Result Reports
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
Female
Age Range
18 Years - N/A
Who Can Participate
Patients
Number of Participants
770
Participant Inclusion Criteria
    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

    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 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
Participant Exclusion Criteria
This is in the inclusion criteria above
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
Manchester
M20 4BX
Local Institution
Glasgow
Central
Local Institution
Plymouth
Devon
Local Institution
London
Greater London
Belfast
Nottingham
Nottinghamshire
NG5 1PB
Cardiff
Royal Free Hospital
London
NW1 2BU
Brook Lane Surgery
Southampton
Uni Hospital Leicester
Leicester
Uni Hospital North Staffordshire
Stoke-on-Trent
Derby
Brighton
Sheffield
S10 2SJ
Research Site
Wirral
Cheltenham General Hospital and Gloucestershire Royal Infirmary
Cheltenham
Castle Hill Hospital
Hull
Lincoln County Hospital, Pilgrim Hospital, Grantham and District Hospital
Lincoln
The James Cook University Hospital
Middlesbrough
Northampton General Hospital
Northampton
Boston
Grantham
Site Reference ID/Investigator# 125689
Barnstaple
EX31 4JB
Research Site
Wolverhampton
Gloucestershire Royal Hospital
Gloucester
Norfolk & Norwich University Hospital
Norfolk
Royal Devon and Exeter NHS Foundation Trust
Exeter
EX2 5DY
Trial Contact(s)
Primary Trial Contact
Nicola McGowan
+44 207 679 9866
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
Mexico, United Kingdom
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific 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
EudraCT Number
Not available for this trial
Funder(s)
  • Cancer Research UK
Other Study ID Numbers
UCL 11/0034
Sponsor(s)
University College, London
Key Dates

Recruitment Start Date

Sep 2012

Recruitment End Date

Dec 2017

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date added to source

27 Mar 2012

Date updated in source

17 May 2017