Northern Ireland Cancer Trials Centre/ Northern Ireland Cancer Trials Network Trials Open to Recruitment March 2014

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1 Northern Ireland Cancer Trials Centre/ Northern Ireland Cancer Trials Network Trials Open to Recruitment March 2014 Bladder HABIO Haematuria Biomarker Study Bowel Cancer NSCCG National Study Of Colorectal Cancer Genetics (also available in Altnagelvin, Antrim, Craigavon and Ulster Hospital) 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 liverpredominant metastatic colorectal cancer ARISTOTLE A phase III trial comparing standard versus novel CRT as pre-operative treatment for MRI defined locally advanced rectal cancer Vitamin D in Colorectal Cancer A Randomised Double Blind Placebo- Controlled Clinical Trial of a Single Oral Cholecalciferol Treatment Against Surrogate End Point Biomarkers (SEBs) in Colon Cancer (CRC) Patients ASyMS III Evaluation of the impact of Advanced Symptom Management System (ASyMS ) on the care and delivered to people with breast and colorectal cancer receiving adjuvant chemotherapy (also available in the Ulster Hospital) 1

2 Brain Tumours NBT National brain tumour study Breast Cancer BOCS Breast and Ovarian Cancer Susceptibility EPHOS B Effect of Perioperative AntiHER-2 therapy on Early Breast Cancer Study - Biological Phase 6MP Phase II Clinical Trial Of 6-Mercaptopurine (6MP) And Low-Dose Methotrexate in Patients with known BRCA Defective Tumours ASyMS III Evaluation of the impact of Advanced Symptom Management System (ASyMS ) on the care and delivered to people with breast and colorectal cancer receiving adjuvant chemotherapy (also available in the Ulster Hospital) FAST FORWARD A Randomised Clinical Trial Testing a 1-week Course Of Curative Whole Breast Radiotherapy Against A Standard 3 Week Schedule In Terms Of Local Cancer Control And Late Adverse Effects In Women With Early Breast Cancer BIG 3-07 A randomised phase III study of radiation doses and fractionation schedules in non-low risk ductal carcinoma in-situ (DCIS) of the breast DDRD In Breast Cancer: A Biomarker Phase Study In Patients Receiving Neoadjuvant Chemotherapy Lung Cancer 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 Altnagelvin and Craigavon Hospitals) APRIL Active Palliative Rehabilitation in Lung Cancer (APRIL) study 2

3 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 Altnagelvin Craigavon and Ulster Hospitals) Ovarian Cancer 6MP Phase II Clinical Trial Of 6-Mercaptopurine (6MP) And Low-Dose Methotrexate in Patients with known BRCA Defective Tumours BriTROC-1 Sample collection study to investigate the role of Homologous Recombination Deficiency in platinum sensitivity in recurrent high grade serous ovarian cancer ICON 8 An international phase III randomised trial of dosefractionated chemotherapy compared to standard three-weekly chemotherapy, following immediate primary surgery or as part of delayed primary surgery, for women with newly diagnosed epithelial ovarian, fallopian tube or primary peritoneal cancer Prostate Cancer Stampede Systemic Therapy in Advancing or Metastatic Prostate cancer - Evaluation of Drug Efficacy (information also available at Antrim Hospital) UKGPC UK Genetics Prostate Cancer Study (also available in Altnagelvin, Antrim, 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 at the Ulster Hospital) 3

4 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 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 Renal Cancer STAR A Randomised Multi-Stage Phase II/III Trial of Standard firstline therapy (sunitinib or pazopanib) Comparing Temporary Cessation with Allowing Continuation, at the Time of Maximal Radiological Response, in the treatment of locally advanced and/or metastatic Renal Cancer Stomach/Gastro-oesophageal junction 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 (information also available at Altnagelvin) RTL An analysis of Relative Telomere Length (RTL) during perioperative chemotherapy in patients with operable gastric or gastrooesophageal junction adenocarcinoma DEBIOC A Phase I dose-escalating and safety study of AZD8931 in combination with Oxaliplatin and Capecitabine chemotherapy in patients with Oesophago-gastric adenocarcinoma (information available at Altnagelvin Hospital) Testicular Cancer UK TGCT Genetics Study Identification of testicular germ cell tumour susceptibility genes the UK genetics of testicular cancer study 4

5 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 Altnagelvin, Antrim, Craigavon and Ulster Hospitals) Early Phase Trial AZD0424 A Cancer Research UK Phase I study to determine the maximum tolerated dose of the oral Src/ABL inhibitor AZD0424, and to identify tolerable and effective AZD0424 combination regimens for the treatment of advanced 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 RAvVA - Phase I/II Randomised Trial of 5-Azacitidine versus 5- Azacitidine in combination with Vorinostat in patients withrelapsed Acute Myeloid Leukaemia Ineligible for Intensive 5

6 Chemotherapy 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 REMoDL-B A Randomised Evaluation of Molecular Guided Therapy for Diffuse large B-Cell Lymphoma with Bortezomib (also available at Antrim, Craigavon and Ulster Hospitals) PDX-017 A multi-centre, randomized, phase 3 study of sequential pralatrexate versus observation in patients with previously undiagnosed peripheral t-cell lymphoma who have achieved an objective response following initial treatment with CHOP based chemotherapy (also available at Antrim Hospital) Multiple Myeloma TEAMM: Tackling early morbidity and mortality in myeloma (available at Altnagelvin, Craigavon and Ulster hospitals only) STRATUS A Multicenter, Single-arm, Open-label Study with Pomalidomide in Combination with Low Dose Dexamethasone in Subjects with Refractory or Relapsed and Refractory Multiple Myeloma 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) 6

7 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 MAJIC A RandoMised study of best Available therapy versus JAK Inhibition in patients with high risk Polycythaemia Vera or Essential Thrombocythaemia who are resistant or intolerant to HydroxyCarbamide Children s Cancers (Royal Belfast Hospital for Sick Children) High Risk Neuroblastoma (NB ) High Risk Neuroblastoma Non Metastatic Rhabomyosarcoma (RMS 2005/STS ) Non metastatic Rhabomyosarcoma UKALL 2011 United Kingdom National Randomised Trial for Children and Young Adults with Acute Lymphoblastic Leukaemia and Lymphoma

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