N. Ireland Cancer Trials Centre/ N. Ireland Cancer Trials Network Trials Open to Recruitment June 2013

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1 N. Ireland Cancer Trials Centre/ N. Ireland Cancer Trials Network Trials Open to Recruitment June 2013 Bladder HABIO Haematuria Biomarker Study Bowel Cancer NSCCG National Study Of Colorectal Cancer Genetics (also available in Altnagelvin, Antrim, Craigavon and Ulster Hospital) SCOT Short Course Oncology Therapy (also available in Altnagelvin Antrim and Craigavon Hospitals) CREST The role of endoluminal stenting in the acute management of obstructing colorectal cancer (only available in Ulster Hospital) Low Rectal Low Rectal Cancer Study (only available in Ulster Hospital) PULMICC A randomized trial of pulmonary metasectomy in colorectal cancer FOXFIRE An open-label randomised phase III trial of 5-Flourouracil, Oxaliplatin and Folinic acid +/- Interventional RadioEmbolisation as first line treatment for patients with unresectable liver-only or liver-predominant metastatic colorectal cancer ARISTOTLE A phase III trial comparing standard versus novel CRT as preoperative treatment for MRI defined locally advanced rectal cancer Brain Tumours NBT National brain tumour study 1

2 Breast Cancer POETIC Trial of Perioperative Endocrine Therapy - Individualising Care FH02 Mammographic surveillance in women aged at enhanced familial risk of breast cancer (also available at Craigavon and Ulster Hospitals) BOCS Breast and Ovarian Cancer Susceptibility EPHOS B Effect of Perioperative AntiHER-2 therapy on Early Breast Cancer Study - Biological Phase Children s Cancer Clinical Trials (see list below) Haematological Clinical Trials (see list below) Lung Cancer CONVERT Concurrent Once-Daily Versus Twice-Daily Radiotherapy: A 2-arm randomized, Controlled Trial of Concurrent Chemo-radiotherapy Comparing Twice-daily and Once-daily Radiotherapy Schedules in Patients with Limited Stage Small Cell Lung Cancer (SCLC) and Good Performance Status (information also available at Craigavon Hospital) QUARTZ A Phase III Multi-Centre Randomised Controlled Trial To Assess Whether Optimal Supportive Care Alone (including Dexamethasone) Is As Effective As Optimal Supportive Care (including Dexamethasone) Plus Whole Brain Radiotherapy In The Treatment Of Patients With Inoperable Brain Metastases From Non-Small Cell Lung Cancer (information also available at Craigavon Hospital) APRIL Active Palliative Rehabilitation in Lung Cancer (APRIL) study PIT A Phase III Randomised Trial of Prophylactic Irradiation of Tracts in Patients with Malignant Pleural Mesothelioma Following Invasive Chest Wall Intervention (information also available at Craigavon Hospital) 2

3 Pancreatic Cancer ViP A prospective, phase II, double blinded, multicentre, randomised clinical trial comparing combination gemcitabine and Vandetanib therapy with gemcitabine therapy alone in locally advanced or metastatic pancreatic carcinoma Prostate Cancer Stampede Systemic Therapy in Advancing or Metastatic Prostate cancer - Evaluation of Drug Efficacy (available for information at Antrim Hospital) UKGPC UK Genetics Prostate Cancer Study (also available in Altnagelvin, Craigavon and Ulster Hospital) Radicals Radiotherapy and Androgen Deprivation in Combination after Local Surgery. A Randomised Controlled Trial in Prostate Cancer Rapper Radiogenomics: Assessment of Polymorphisms for Predicting the Effects of Radiotherapy (only available for patients who have participated in RADICALS or CHHIP study or radical radiotherapy in the STAMPEDE study) Tripocare LT A prospective observational study cohort to assess the rate of castration resistance, disease progression and overall survival over a 3-year period post-androgen deprivation therapy induction in patients with advanced prostate cancer who have previously participated in the tripocare study (only available in the Ulster Hospital) DNA Biomarker Study A study examining the change in serum biomarkers of DNA damage and tissue damage in patients undergoing radical radiotherapy for prostate cancer BUStin A randomised trial comparing 2 bladder filling instruction sheets in achieving bladder volume consistency using an ultrasound bladder scan device and biomarker analysis during intensity modulated prostate radiotherapy BAY Radium-223 Chloride (Alpharadin) in Castration- Resistant (Hormone-Refractory) Prostate Cancer Patients with Bone Metastasis 3

4 New!! COMET 2 A Phase 3, randomized, double-blind, controlled trial of cabozantinib (XL184) vs. mitoxantrone plus prednisone in men with previously treated symptomatic castration-resistant prostate cancer Sarcoma GeDDiS A prospective randomized controlled phase III trial of gemcitabine and docetaxel compared with doxorubicin as first line treatment in previously untreated advanced unresectable or metastatic soft tissue sarcomas Stomach Cancer STO3 A Randomised Phase II/III Trial of Peri-Operative Chemotherapy with or without Bevacizumab in Operable Adenocarcinoma of the Stomach and Gastro- oesophageal Junction Testicular Cancer UK TGCT Genetics Study Identification of testicular germ cell tumour susceptibility genes the UK genetics of testicular cancer study Studies not specific to a particular type of cancer ICBP NI M4 Root causes of diagnosis and treatment delay (International benchmarking Partnership Module 4) (also available at Antrim, Craigavon and Ulster Hospitals) Early Phase Trial A A Parallel Arms Phase 1 Safety, Pharmacokinetic And Pharmacodynamic Study Of The Intravenous Poly(ADP-RIBOSE) Polymerase (PARP) Inhibitor PF (AG ) In Combination with Several Chemotherapeutic Regimens In Adult Patients With Advanced Solid Tumours SHIONOGI Phase 1 Open label, dose escalation study of S in patients with Solid Tumours 4

5 WILEX A Phase I/II, open-label, dose-escalation study to investigate the safety, pharmacokinetics, pharmacodynamics and clinical activity of the MEK inhibitor WX-554 in patients with solid tumours Translational Study HER Shedding A pilot study investigating the predictive role of chemotherapy-induced changes in serum Human Epidermal Receptor (HER) ligand levels in patients with solid tumours Haematological Clinical Trials Leukaemia AML 17 A programme of development for the treatment of younger patients with acute myeloid leukaemia and high risk myelodysplastic syndrome UKALL 14 A randomised trial for adults with newly diagnosed acute lymphoblastic leukaemia Genomic and epigenetic analysis of AML and MDS APL Understanding and Managing the Coagulopathy Of Acute Promyelocytic Leukaemia in the Acute Stage Pilot Study LI-1 A Programme Of Development For Older Patients With Acute Myeloid Leukaemia And High Risk Myelodysplastic Syndrome RIAltO - A Randomised Investigation of Alternative Ofatumumab containing regimens in less fit patients with CLL Lymphoma PACIFICO Purine-Alkylator Combination In Follicular lymphoma Immuno-Chemotherapy for Older patients: a phase III comparison of first-line R-CVP versus R-FC (also available in Altnagelvin) 5

6 REMoDL-B A Randomised Evaluation of Molecular Guided Therapy for Diffuse large B-Cell Lymphoma with Bortezomib (also available at Antrim, Craigavon and Ulster Hospital) NSHLG National Study of Hodgkin's Lymphoma Genetics (also available at Antrim, Craigavon and Ulster Hospital) Multiple Myeloma PADIMAC Phase II Study Of Bortezomib, Adriamycin and Dexamethasone (PAD) Therapy For Previously Untreated Patients With Multiple Myeloma: Impact Of Minimal Residual Disease (MRD) In Patients With Deferred ASCT Other Haematological Expanded PNH Registry Paroxysmal Nocturnal Haemoglobinuria (PNH) Registry MOSAICC Myeloproliferative Neoplasms: An In-Depth Case-Control Study (Pilot Study) Early Phase Trial INCA 2201 A Phase Ib, Open-Label, Dose-Finding Study Of The JAK- Inhibitor INC424 Tablets Administered Orally To Patients With Primary Myelofibrosis (PMF), Post-Polycythaemia Vera-Myelofibrosis (PPV-MF) Or Post-Essential Thrombocythemia-Myelofibrosis (PET-MF) And Baseline Platelet Counts > 50 X 10 9 /L And <100 X 10 9 /L Clonal Blood Cell Disorder The causes of clonal blood disorders Genomic and epigenetic analysis of AML and MDS ARDS A Randomised Phase II, Open-Label study of the Efficacy and Safety of Orally Administered SAR in patients with polycythaemia vera (PV) or essential thrombocythaemia (ET) who are resistant or intolerant to hydroxyurea MAJIC A RandoMised study of best Available therapy versus JAK Inhibition in patients with high risk Polycythaemia Vera or Essential 6

7 Thrombocythaemia who are resistant or intolerant to HydroxyCarbamide Children s Cancers (Royal Belfast Hospital for Sick Children) EURO EWING 99 (ET ) European Ewing Tumour Working Initiatives of National Groups: Ewing Tumours Studies 1999 High Risk Neuroblastoma (NB ) High Risk Neuroblastoma Non Metastatic Rhabomyosarcoma (RMS 2005/STS ) Non metastatic Rhabomyosarcoma Relapsed ALL (ALLR3) Relapsed ALL UKALL 2011 United Kingdom National Randomised Trial for Children and Young Adults with Acute Lymphoblastic Leukaemia and Lymphoma