Warwick Clinical Trials Unit: Cancer Research www.warwick.ac.uk/go/ctu Experience Overview Future Aims The cancer team at Warwick CTU was established in January 2006 under the leadership of Professor Janet Dunn. It provides support and expertise in the design, conduct, analyses and reporting of national, multicentre, cancer clinical trials. The team has an excellent track record of conducting trials in early breast, GI, colorectal, melanoma and multiple myeloma with an impressive publication record in high impact journals e.g. NEJM, JCO, Blood, Lancet, BMJ. Warwick Clinical Trials Unit is an academic unit undertaking clinical trials addressing real issues of local, national and international importance. It gained UKCRC full CTU registration status in 2007 which demonstrates the quality and national reputation of the CTU. Establish Warwick as a National Cancer Research Institute (NCRI) accredited cancer clinical trials unit and continue to deliver high impact clinical trials within the national portfolio of cancer trials. Expand the Warwick programme of head and neck cancer research. The Warwick CTU cancer team are conducting national trials in early breast, ovarian and head and neck cancers, as well as providing the randomisation, programming and statistical support for national trials of melanoma, stomach cancer and myeloma. The team specialises in the application of complex statistical methods needed for large scale cancer trials e.g. survival analysis, evaluation of prognostic and predictive indices, handling of missing data and analysis of potential biomarkers. Continue to work closely with the Arden Cancer Network under the leadership of Professor Bob Grieve, providing support to local Chief Investigators. Establish the early phase clinical trials unit at UHCW under the leadership of Professor Chris Poole. Total grant income of £6 million has been awarded to the Warwick CTU cancer trials over the last 3 years, supporting the following trials: Persephone PET-Neck NEO-ESCAPE ARTemis A phase III rial comparing 6 months Trastuzamab treatment with 12 months in women with early stage breast cancer A phase III trial comparing PET-CT guided watch and wait policy versus planned neck dissection for the management of advanced (N2/N3) nodal metastases in patients with head and neck squamous cancer A phase II feasibility trial of neoadjuvant sequential chemotherapy with adjuvant post operative treatment for epithelial non-mucinous advanced inoperable peritoneal malignancy A phase III Avastin Randomised Trial with neo-adjuvant chemotherapy for patients with early breast cancer Chief Investigator: Dr Helena Earl, Addenbroke’s Hospital Chief Investigator: Mr Hisham Mehanna, UHCW Chief Investigator: Dr Chris Poole, UHCW Chief Investigator: Dr Helena Earl, Adenbrookes Hospital Primary Objective: Disease free survival non-inferiority (equivalence) of 6 months vs 12 months Trastuzamab. Primary Objective: Non-inferiority of PET-CT surveillance compared with planned neck dissection. Primary Objective: chemotherapy. Recruitment target: Recruitment to date: Recruitment target: Recruitment to date: Recruitment target: Recruitment to date: 4,000 patients 133 patients Contact Jas Sandhu j.sandhu@warwick.ac.uk (024) 761 50492 POSTER TEMPL ATE BY: www.PosterPresentations.com 560 patients 32 patients Contact Claire Balmer c.balmer@warwick.ac.uk (024) 761 50478 Completion of Contact Primary Objective: Complete pathological response rates (no residual invasive carcinoma and no evidence of metastatic disease within lymph nodes) Recruitment target: 800 patients Recruitment to date: to start April 2009 Contact Julie Fletcher j.fletcher@warwick.ac.uk (024) 769 68620 Claire Daffern artemis@warwick.ac.uk (024) 761 50605 88 patients 13 patients 12 cycles of