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

Study acronym: INTERLACE
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated December 5, 2024 (before its estimated February 2026 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Minor Re-verified, no change to tracked fieldsv13
  2. Notable Primary completion date: Aug 2022 to Feb 2026v12 Show 4 more changesShow less
    • Start date: Sep 2012 to Nov 8, 2012
    • Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 36 to 35
    • Study completion date: May 2026 to Dec 2026
  3. Minor Study sites: 35 to 36v11
  4. Notable Primary completion date: Feb 2021 to Aug 2022
    • Study sites: 32 to 35
    • Study completion date: Dec 2024 to May 2026
    v10
  5. Notable Enrollment target: 770 to 500
    • Study sites: 30 to 32
    • Primary completion date: Dec 2020 to Feb 2021
    • Study completion date: Sep 2021 to Dec 2024
    v9
Show 7 earlier versionsHide 7 earlier versions
  1. Notable Primary completion date: Sep 2018 to Dec 2020
    • Site details revised at 1 of 30 sites
    v8
  2. Notable Primary completion date: Dec 2017 to Sep 2018v7
  3. Notable Primary completion date: Sep 2016 to Dec 2017
    • Study sites: 28 to 30
    v6
  4. Minor Study sites: 26 to 28
    • Eligibility criteria expanded, about 14 words
    v5
  5. Minor Study sites: 6 to 26
    • Eligibility criteria shortened, about 8 words
    v4
  6. Minor Re-verified, no change to tracked fieldsv3
  7. Notable Trial status: Not Yet Recruiting to Recruitingv2 Show 7 more changesShow less
    • Study sites: 18 to 6
    • Primary completion date: Jun 2016 to Sep 2016
    • Study completion date: Jun 2021 to Sep 2021
    • Start date: Sep 2012
    • Eligibility criteria shortened, about 22 words
    • Secondary endpoints: details revised at 3 of 4 entries
    • Study title shortened, about 16 words
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT01566240
Lead Sponsor University College, London
Collaborators: Cancer Research UK
Conditions
(from sponsor)
Cervical Cancer
Related terms Uterine Cervical Neoplasms
Enrollment 500 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov