ORCA

• Research type

  Research Study

• Full title

  A phase I/II study of olaparib in addition to cisplatin-based concurrent chemoradiotherapy for patients with high risk locally advanced squamous cell carcinoma of the head and neck (HNSCC)

• IRAS ID

  67332

• Contact name

  Martin Forster

• Sponsor organisation

  University College London

• Eudract number

  2010-023599-24

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  ResearHead and neck squamous cell carcinoma (HNSCC) is the 6th most common cancer in the world, accounting for >7500 of recorded cases in the UK (2006 data). Currently the standard treatment for high risk locally advanced HNSCC is cisplatin chemotherapy alongside high dose radiotherapy, however local recurrence rates are high at approximately 80%. This means there is a real need to look at improving local disease control in this group of patients. The purpose of this Phase I trial is to assess how olaparib, a PARP inhibitor is tolerated when added to standard chemoradiotherapy (CRT) treatment. This is a dose escalation trial which aims to find out the recommended dose and the best dosing schedule for olaparib in combination with cisplatin based CRT. Patients will be recruited from sites in the UK and the total number recruited will depend on the outcome of the dose escalation (expected to be around 40). This study is funded by Cancer Research UK and Astra Zeneca. A placebo controlled, randomised Phase II trial will follow once the recommended dose of olaparib has been established.

• REC name

  London - City & East Research Ethics Committee

• REC reference

  11/LO/1618

• Date of REC Opinion

  12 Dec 2011

• REC opinion

  Further Information Favourable Opinion