INTERLACE

• Research type

  Research Study

• Full 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

• IRAS ID

  73866

• Contact name

  Mary McCormack

• Sponsor organisation

  University College London

• Eudract number

  2011-001300-35

• ISRCTN Number

  na

• Research 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 we 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 47-79). These results, together with acceptable toxicity, provide justification for evaluating induction chemotherapy prior to chemoradiation in a randomised phase III trial. We 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. We 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 3 additional years of follow up.

• REC name

  South Central - Oxford B Research Ethics Committee

• REC reference

  11/SC/0528

• Date of REC Opinion

  31 Jan 2012

• REC opinion

  Further Information Favourable Opinion