ORCA-2
Research type
Research Study
Full title
A phase I 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
163223
Contact name
Rubina Begum
Contact email
Sponsor organisation
University College London
Eudract number
2014-002525-35
Duration of Study in the UK
4 years, 0 months, 0 days
Research summary
Squamous cell carcinoma of the head and neck (HNSCC) is the 6th most common cancer in the world, accounting for more than 9000 cases in the UK (2011 data). Currently the standard treatment for high risk locally advanced HNSCC is surgery or chemoradiotherapy, however local recurrence rates are high (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 cisplatin-based chemoradiotherapy (C-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. One or two of the cohorts from the escalation phase will be selected for expansion. During the expansion phase patients will receive induction chemotherapy before starting olaparib + C-CRT.
Patients will be recruited from sites in the UK and the total number recruited will depend on the outcome of the dose escalation and expansion of cohorts (expected to be up to 70).
This study is funded by Cancer Research UK and AstraZeneca.
REC name
London - London Bridge Research Ethics Committee
REC reference
14/LO/2153
Date of REC Opinion
19 Feb 2015
REC opinion
Further Information Favourable Opinion