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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01566240
Recruitment Status : Recruiting
First Posted : March 29, 2012
Last Update Posted : September 27, 2019
Cancer Research UK
Information provided by (Responsible Party):
University College, London

Brief 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.

Condition or disease Intervention/treatment Phase
Cervical Cancer Drug: Paclitaxel Drug: Carboplatin Radiation: Radiotherapy Drug: Cisplatin Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 770 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : September 2012
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

Arm Intervention/treatment
Active Comparator: Chemoradiation
Radiotherapy (external beam and brachytherapy) plus concurrent Cisplatin weekly for 5 weeks
Radiation: 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.

Drug: 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.

Experimental: Induction Chemotherapy + Chemoradiation
6 cycles of weekly Paclitaxel and Carboplatin followed by Chemoradiation as per Active Comparator
Drug: Paclitaxel
Paclitaxel 80 mg/m2 (capped at 160mg maximum total dose) weekly for 6 weeks i.e. on days 1, 8, 15, 22, 29 & 36.

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.

Radiation: 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.

Drug: 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.

Primary Outcome Measures :
  1. Overall Survival [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Progression free survival [ Time Frame: 12 weeks post treatment and then as required ]
  2. Adverse events (AE) as assessed by the Common Terminology Criteria for Adverse Events v4.03 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 12 weeks post treatment and as required ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01566240

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Contact: Josie Bourner +44 207 679 9866

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Instituto Nacional de Cancerologia (INCAN) Recruiting
Mexico City, Mexico
Principal Investigator: Dolores Dr Gallardo         
United Kingdom
North Devon District Hospital Recruiting
Barnstaple, Devon, United Kingdom, EX31 4JB
Principal Investigator: Jennifer Forrest         
University College London Hospital Recruiting
London, Greater London, United Kingdom, NW1 2BU
Principal Investigator: Mary McCormack         
Weston Park Hospital Recruiting
Sheffield, South Yorkshire, United Kingdom, S10 2SJ
Principal Investigator: Simon Pledge         
Belfast City Hospital Recruiting
Belfast, United Kingdom
Principal Investigator: Ursula Dr McGiven         
Pilgrim Hospital Recruiting
Boston, United Kingdom
Principal Investigator: Miguel Dr Panades         
Royal Sussex County Hospital Recruiting
Brighton, United Kingdom
Principal Investigator: Kate Dr Lankester         
Velindre Cancer Centre Recruiting
Cardiff, United Kingdom
Principal Investigator: Louise Dr Hanna         
Cheltenham General Hospital Recruiting
Cheltenham, United Kingdom
Principal Investigator: Audrey Dr Cook         
Royal Derby Hospital Recruiting
Derby, United Kingdom
Principal Investigator: Mojca Dr Persic         
Royal Devon and Exeter NHS Foundation Trust Recruiting
Exeter, United Kingdom, EX2 5DY
Principal Investigator: Jennifer Forrest         
Beatson WOSCC Recruiting
Glasgow, United Kingdom
Principal Investigator: Nick Dr Reed         
Gloucester Royal Hospital Recruiting
Gloucester, United Kingdom
Principal Investigator: Audrey Dr Cook         
Grantham and District Hospital Recruiting
Grantham, United Kingdom
Principal Investigator: Miguel Dr Panades         
Castle Hill Hospital Recruiting
Hull, United Kingdom
Principal Investigator: Faheem Dr Bashir         
Leicester Royal Infirmary Recruiting
Leicester, United Kingdom
Principal Investigator: David Dr Peel         
Lincoln County Hospital Recruiting
Lincoln, United Kingdom
Principal Investigator: Miguel Dr Panades         
Guy's and St Thomas' NHS Foundation Trust Recruiting
London, United Kingdom
Principal Investigator: Vinod Dr Mullassery         
Imperial College Healthcare NHS Trust Recruiting
London, United Kingdom
Contact: Sophie Kathirgamanathan         
Principal Investigator: Gemma EMinowicz         
St Bart's Hospital Recruiting
London, United Kingdom
Principal Investigator: Melanie Dr Powell         
The Christie NHS Foundation Trust Recruiting
Manchester, United Kingdom, M20 4BX
Principal Investigator: Susan Davidson         
James Cook University Hospital Recruiting
Middlesbrough, United Kingdom
Principal Investigator: Madhavi Dr Adusumalli         
Northampton General Hospital Recruiting
Northampton, United Kingdom
Principal Investigator: Anupama Dr Gore         
Norfolk and Norwich University Hospital Recruiting
Norwich, United Kingdom
Principal Investigator: Robert Dr Wade         
Nottingham University Hospitals NHS Trust Recruiting
Nottingham, United Kingdom, NG5 1PB
Principal Investigator: Anjana Anand         
Derriford Hospital Recruiting
Plymouth, United Kingdom
Contact: Irene Harvey         
Principal Investigator: Sidharth Dubey         
Southampton General Hospital Recruiting
Southampton, United Kingdom
Principal Investigator: Victoria Dr Lankaster         
Royal Stoke University Hospital Recruiting
Stoke-On-Trent, United Kingdom
Principal Investigator: Rajanee Dr Bhana         
The Clatterbridge Cancer Centre Recruiting
Wirral, United Kingdom
Principal Investigator: Karen Dr Whitmarsh         
New Cross Hospital Recruiting
Wolverhampton, United Kingdom
Principal Investigator: Rozenne Dr Allerton         
Sponsors and Collaborators
University College, London
Cancer Research UK
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Principal Investigator: Mary Dr McCormack, MBBS, FRCR University College London Hospitals NHS Foundation Trust

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Responsible Party: University College, London Identifier: NCT01566240     History of Changes
Other Study ID Numbers: UCL 11/0034
2011-001300-35 ( EudraCT Number )
C37815/A12832 ( Other Grant/Funding Number: CRUK )
First Posted: March 29, 2012    Key Record Dates
Last Update Posted: September 27, 2019
Last Verified: September 2019
Keywords provided by University College, London:
cervical cancer
Stage IB2 Cervical Cancer
Stage IIA Cervical Cancer
Stage IIB Cervical Cancer
Stage IIIB Cervical Cancer
Stage IVA Cervical Cancer
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action