1. Wrexham Maelor Lung Clinical Trials Overview February 2008

2.  The Wales Cancer Trials Network (WCTN) supports cancer clinical research in Wales.  WCTN is funded by Cancer Research UK and the Wales Assembly Government  The Network supports prospective trials of cancer treatments and other well-designed studies endorsed by government research councils, academic research groups and cancer charities, with the ultimate effect of delivering benefits to patients more quickly.  The Network provides direct support to 14 hospitals across Wales. Support includes funding for research staff and equipment, training, information and co-ordination.

3. The WCTN works to:  Make research a more routine and acceptable part of high quality NHS care  Improve equity of access to trials of new treatments  Meet the Wales Cancer Standards (2005) for research by increasing involvement and recruitment into clinical trials across Wales.

4.  Clinical Research Collaboration Cymru (CRC Cymru) was developed as part of the strategic work programme of the Wales Office of Research and Development (WORD) to provide a research infrastructure for health and social care in Wales.  CRC Cymru comprises ten research networks, six research infrastructure and technical support groups, three trials units and a co-ordinating centre.

5. Research Staff  1 Research Nurse, 0.8wte who works on Breast, Colorectal, Upper GI, Gynaecology, Urology & Lung Portfolio at Wrexham Maelor Hospital.  Links with research team in NWCTC in the setting-up, screening, recruitment and co-ordination of clinical trials.  Administration support via NWCTC.

6. Role of the Research Staff  Patient advocate and support  Information and informed consent  Trial management and data collection  Follow up and assessment  Resource for other staff

7. Collaborative working  Communication / liaison with MDT.  Streamlining patient journey.  Reducing duplication.  Resource for each other.  Providing patient information.

8. Aims / Purpose of Trials.  Answer clinical questions / extend knowledge.  Test effectiveness of new treatments.  Improve on current treatments.  Assess Quality of Life (QOL).  Provide the foundation for clinical practice.

9. Clinical Trials Phases: I Test dose safety. II Test efficacy/response III Standard vs trial treatment IV Post-marketing surveillance

10. Cancer Trials Pathway  Detailed Costing of trial  Wrexham Haemat-Oncology Trials Review Committee (meets every two months)  IRMER application  Local Research Ethics Committee.  North East Wales Research & Development Committee.  Risk assessment.  Approval process can take up to three months.

11. Trial NameTrial StatusPrincipal Investigator RecruitmentIn Follow upTotal FRAGMATICOPENDR.GARCIA00 BTOG-2IN SET UPDR.GARCIA QUARTZIN SET UPDR.GARCIA MALCSIN SET UPDR.GARCIA TACTICIN SET UPDR.GARCIA LUNG PORTFOLIO

12. TRIAL SYNOPSIS FRAGMATIC: Phase III trial investigating the effect of FRAGMin Added to standard Therapy In patients with lung Cancer. QUARTZ: Trial to assess whether optimal supportive care alone (including dexamethasone) is as effective as optimal supportive care (including dexamethasone) plus whole brain radiotherapy for patients with inoperable brain metastases from non-small cell lung cancer (5# radiotherapy) BTOG-2: Phase III randomised trial of gemcitabine plus cisplatin at 80mg/m2 vs gemcitabine plus cisplatin at 50mg/m2 vs gemcitabine plus carboplatin AUC6 in stage IIIB/IV non-small cell lung cancer

13. TRIAL SYNOPSIS MALCS: A population based control study of mesothelioma and lung cancer in relation to occupation among British men and women TACTIC: A randomised phase II double blind placebo controlled trial of whole brain radiotherapy (WBRT) and Tarceva OSI-774, erlotinib in patients with advanced non-small cell lung cancer and multiple brain metastases

14. USEFUL LINKS National Cancer Research Network (NCRN) www.ncrn.org.uk Wales Cancer trials Network (WCTN) www.wctn.org.uk CRC Cymru www.wales.nhs.uk National Cancer Research Institute (NCRI) www.ncri.org.uk

15. Contact details CERI GRIFFITHS ONCOLOGY RESEARCH NURSE WREXHAM MAELOR HOSPITAL TELEPHONE: 01978 726063 FAX: 01978 726062 E-MAIL: CERI.GRIFFITHS@new-tr.wales.nhs.ukCERI.GRIFFITHS@new-tr.wales.nhs.uk