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Trial Details
Trial status:
In follow-up (non-recruiting)
Recruitment start date:
28/09/2015
Funder:
Cancer Research UK
Sponsor:
UCL
Chief Investigator:
Dr Martin Forster
Recruitment target:
50
EudraCT number:
2014-002525-35
Contact details:
ctc.orca2@ucl.ac.uk
Lay summary:
ORCA-2
ORCA-2: 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 (NHSCC).
Description
Design: ORCA-2 is 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). The trial will use a two dimensional dose escalation design increasing the dose and weekly duration of dosing of olaparib until the maximum tolerated dose (MTD) and schedule is found. An expansion cohort will recruit additional patients at the MTD in order to define the recommended phase II dose and schedule. 
Treatment: All patients will receive olaparib and cisplatin-based chemoradiotherapy. Radiotherapy will be delivered at a fixed dose of 70Gy, given in 2 Gy fractions alongside weekly cisplatin at dose of 35mg/m2 over a 7 week period. Alongside this olaparib will be taken orally twice daily on a weekly dosing schedule determined by the patient’s cohort for a total of 8 weeks. 
Key inclusion/exclusion criteria: Patients must have histologically confirmed high risk locally advanced head and neck squamous cell carcinoma (HNSCC). Nasopharyngeal and paranasal sinus tumours are excluded as well as oral squamous cell carcinomas and any patients with low risk HPV+ positive oropharyngeal tumours. Patients must also not have had any previous chemotherapy or radiotherapy for the treatment of HNSCC or have any confirmed metastatic disease.
Duration of recruitment: Anticipated recruitment for the escalation phase of the trial will take approximately 29 months and the expansion phase approximately 15 months.
Aim
The overall aim of the trial is to assess the safety profile and determine the recommended phase II dose and schedule of olaparib in combination with weekly cisplatin-based chemoradiotherapy and to also to assess preliminary evidence of anti-tumour activity.
Trial protocols
Trial protocols must not be applied to patients treated outside trials. UCL CTC can only ensure that approved trial investigators are provided with amendments to protocols.
No protocols have been currently made available for download
Trial documents
No documents have been currently made available for download
Contact Us
Cancer Research UK & UCL Cancer Trials Centre
University College London
90 Tottenham Court Road
London
W1T 4TJ

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Email:
ctc.enquiries@ucl.ac.uk
Telephone:
+44 (0)20 7679 9898 (General CTC Enquiries)
Fax:
020 7679 9899
University College London, Gower Street, London, WC1E 6BT +44 (0)20 7679 2000

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