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

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ClinicalTrials.gov Identifier: NCT01566240
Recruitment Status : Recruiting
First Posted : March 29, 2012
Last Update Posted : June 21, 2022
Sponsor:
Collaborator:
Cancer Research UK
Information provided by (Responsible Party):
University College, London

Tracking Information
First Submitted Date  ICMJE March 27, 2012
First Posted Date  ICMJE March 29, 2012
Last Update Posted Date June 21, 2022
Study Start Date  ICMJE September 2012
Estimated Primary Completion Date August 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 12, 2013)
Overall Survival [ Time Frame: 5 years ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 28, 2012)
Overall Survival
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 12, 2013)
  • Progression free survival [ Time Frame: 12 weeks post treatment and then as required ]
  • 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. ]
  • 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) ]
  • Patterns of first relapse (local and/or systemic) [ Time Frame: 12 weeks post treatment and as required ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 28, 2012)
  • Progression free survival
  • 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. ]
  • Quality of Life (UK and Ireland only) as assessed by EORTC QLQ-C30, QLQ-CX24 and EQ-5D [ Time Frame: Patients will fill in the questionnaires at the following timepoints: Baseline, before CRT, During CRT, Post CRT, 3 monthly for 2 years; 6 monthly for 3 years ]
  • Patterns of first relapse (local and/or systemic)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Induction Chemotherapy Plus Chemoradiation as First Line Treatment for Locally Advanced Cervical Cancer
Official Title  ICMJE A Phase III Multicentre Trial of Weekly Induction Chemotherapy Followed by Standard Chemoradiation Versus Standard Chemoradiation Alone in Patients With Locally Advanced Cervical Cancer
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cervical Cancer
Intervention  ICMJE
  • Drug: 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.
  • 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.
Study Arms  ICMJE
  • Active Comparator: Chemoradiation
    Radiotherapy (external beam and brachytherapy) plus concurrent Cisplatin weekly for 5 weeks
    Interventions:
    • Radiation: Radiotherapy
    • Drug: Cisplatin
  • Experimental: Induction Chemotherapy + Chemoradiation
    6 cycles of weekly Paclitaxel and Carboplatin followed by Chemoradiation as per Active Comparator
    Interventions:
    • Drug: Paclitaxel
    • Drug: Carboplatin
    • Radiation: Radiotherapy
    • Drug: Cisplatin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 13, 2019)
500
Original Estimated Enrollment  ICMJE
 (submitted: March 28, 2012)
770
Estimated Study Completion Date  ICMJE May 2026
Estimated Primary Completion Date August 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Anne-Marie Mullin +44 207 679 9010 ctc.interlace@ucl.ac.uk
Listed Location Countries  ICMJE Brazil,   India,   Italy,   Mexico,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01566240
Other Study ID Numbers  ICMJE UCL 11/0034
2011-001300-35 ( EudraCT Number )
C37815/A12832 ( Other Grant/Funding Number: CRUK )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party University College, London
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University College, London
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Cancer Research UK
Investigators  ICMJE
Principal Investigator: Mary Dr McCormack, MBBS, FRCR University College London Hospitals
PRS Account University College, London
Verification Date June 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP