Portfolio – Open Trials – Northern Ireland Cancer Trials Network

Northern Ireland Cancer Trials Network

Belfast Experimental Cancer Medicine Centre

TRIALS OPEN TO RECRUITMENT – June 2019

Please note that while we aim to update the NICTN clinical trials list on a monthly basis, the availability of clinical trials changes over this period. For the latest information we advise patients to discuss clinical trial availability with their own doctor.

THE NICTN OPEN CLINICAL TRIALS LIST

Bladder Cancer

RAIDER A Randomised phase II trial of Adaptive Image guided standard or Dose Escalated tumour boost Radiotherapy in the treatment of transitional cell carcinoma of the bladder

Bowel Cancer

NSCCG National Study Of Colorectal Cancer Genetics [ON HOLD ANTRIM]

BALLAD UK A trial to evaluate the potential benefit of adjuvant chemotherapy for small bowel adenocarcinoma

CReST 2 Colorectal Stenting Trial 2 – Uncovered and Covered Endoluminal Stenting in the acute management of obstructing colorectal cancer in the palliative setting

ADD ASPIRIN A Phase III, Double-Blind, Placebo-Controlled Randomised Trial Assessing the Effects of Aspirin on Disease Recurrence and Survival after Primary Therapy in Common Non-Metastatic Solid Tumours

CHALLENGE A phase III study of the impact of a physical activity programme on disease-free survival in patients with high risk stage II or stage III colon cancer: A randomised controlled trial

Brain Tumours

ROAM Radiation Versus Observation Following Surgical Resection Of Atypical Meningioma: A Randomised Controlled Trial

Breast Cancer

POSNOC POsitive Sentinel NOde: adjuvant therapy alone versus adjuvant therapy plus Clearance or axillary radiotherapy. A randomised controlled trial of axillary treatment in women with early stage breast cancer who have metastases in one or two sentinel nodes

Olympia A randomised, double-blind, parallel group, placebo-controlled multi-centre Phase III study to assess the efficacy and safety of olaparib versus placebo as adjuvant treatment in patients with germline BRCA1/2 mutations and high risk HER2 negative primary breast cancer who have completed definitive local treatment and neoadjuvant or adjuvant chemotherapy

LORIS A Phase III Trial of Surgery versus Active Monitoring for Low Risk Ductal Carcinoma in Situ (DCIS)

OPTIMA Optimal Personalised Treatment of early breast cancer using Multi-parameter Analysis

PIONEER Randomised Phase II clinical trial PIONEER- A Pre-operative wIndOw study of Letrozole plus PR agonist (Megestrol Acetate) versus Letrozole aloNE in post-menopausal patients with ER-positive breast cancer

ARCS-Multi Phase 1b multi-indication study of anetumab ravtansine (BAY 94-9343) in patients with mesothelin expressing advanced or recurrent malignancies (including triple negative breast cancer)

SELF- MANAGEMENT ONLINE SHOULDER EXERCISES AFTER BREAST CANCER SURGERY Designing, developing and testing a web-based tailored intervention for self-management exercising to enable optimal shoulder and arm outcomes after surgery for breast cancer (Also available in Craigavon and the Ulster Hospital)

PRIMETIME Post-operative avoidance of radiotherapy in minimal risk women: patient selection using biomarkers

Cervical Cancer

INTERLACE A phase III multicentre trial of weekly induction chemotherapy followed by standard chemoradiation versus standard chemoradiation alone in patients with locally advanced cervical cancer

Children’s Cancers (Royal Belfast Hospital for Sick Children)

UKALL 2011 United Kingdom National Randomised Trial for Children and Young Adults with Acute Lymphoblastic Leukaemia and Lymphoma 2011

IMPORT A SIOP Renal Tumours Study Group Prospective Clinical Study. Improving Population Outcomes for Renal Tumours of Childhood

EURO Ewing 2012 International Randomised Controlled Trial for the Treatment of Newly Diagnosed Ewing’s Sarcoma Family of Tumours

rEECur International Randomised Controlled Trial of Chemotherapy for the Treatment of Recurrent and Primary Refractory Ewing Sarcoma

Ewings PK 2013 Study Pilot study to investigate the early prediction of toxicity following induction chemotherapy in Ewing’s sarcoma by blood-borne biomarkers and correlation with age-dependent pharmacokinetic variation

Myechild01 International Randomised Phase III Clinical Trial in Children with Acute Myeloid Leukaemia – Incorporating an Embedded Dose Finding Study for Gemtuzumab Ozogamicin in Combination with Induction Chemotherapy

SIOP Ependymoma II An International clinical program for the diagnosis and treatment of children, adolescents and young adults with ependymoma

Relapse in UK Neuroblastoma Clinical and Biological factors associated with relapse and length of survival following relapse in UK neuroblastomas

LCH-IV International Collaborative Treatment Protocol for Children and Adolescents with Langerhans Cell Histiocytosis

PHITT Paediatric Hepatic International Tumour Trial

Head and Neck Cancer

iNATT The interNational Anaplastic Thyroid Cancer Tissue Bank and Database Project

Ion Is ablative radioiodine necessary for low risk differentiated thyroid cancer

NIMRAD A randomised placebo-controlled trial of synchronous nimorazole versus radiotherapy alone in patients with locally advanced head and neck squamous cell carcinoma not suitable for synchronous chemotherapy or cetuximab

Haematological Cancers (see below)

Lung Cancer

Stratified Medicine Programme 2 Cancer Research UK Stratified Medicine Programme 2

National Lung Matrix Trial National Lung Matrix Trial: Multi-drug, genetic marker-directed, non-comparative, multi-centre, multi-arm phase II trial in non-small cell lung cancer

CORE A Randomised Trial Of Conventional Care Versus Radioablation (Stereotactic Body Radiotherapy) For Extracranial Oligometastases

SYSTEMS-2 A Randomised Phase II Trial of Standard Versus Dose Escalated Radiotherapy in the Treatment of Pain in Malignant Pleural Mesothelioma

SARON Stereotactic ablative radiotherapy for oligometastatic non-small cell lung cancer. A randomized phase III trial.

KEYNOTE-598 A Phase 3, Randomized, Double-Blind Study of Pembrolizumab plu sIpilimunab plus Placebo in Previously Untreated, Stage IV, Metastatic Non-small Cell lung Cancer Subjects Whose Tumors are PD-L1 Postive (TPS ≥ 50%)

CONFIRM (Checkpoint Blockade For Inhibition Of Relapsed Mesothelioma) A Phase III Double-Blind, Placebo Controlled Trial To Evaluate The Efficacy Of Nivolumab In Relapsed Mesothelioma

HALT Lung cancer “Targeted therapy with or without dose intensified radiotherapy for oligo-progressive disease in oncogene-addicted lung tumours”

FAK-PD1 A Phase I/IIA Study to Assess Safety, Tolerability and Preliminary Activity of FAK (defactinib) and PD-1 (Pembrolizumab) Inhibition in Patients with Advanced Solid Malignancies (including non-small cell lung cancer)

PROFILES bnP for pRediction of Outcome FollowIng Lung rEsection Surgery [NEW]

Melanoma

INTERIM A randomised phase II feasibility study of INTERmittent versus continuous dosing or oral targeted combination therapy In patients with BRAFV600 mutant stage 3 unresectable or metastatic Melanoma

DANTE A randomised phase III trial to evaluate the Duration of ANti-PD1 monoclonal antibody Treatment in patients with metastatic mElanoma

Oesophageal Cancer

OCCAMS Multicentre Study to determine Predictive and Prognostic Biomarkers and Therapeutic Targets for Oesophageal and Junctional Adenocarcinoma including whole genome sequencing

Neo-AEGIS (NEOadjuvant trial in Adenocarcinoma of the oEsophagus and oesophagoGastric junction International Study): Randomised Clinical Trial of neoadjuvant and adjuvant chemotherapy (Modified MAGIC regimen) vs. neoadjuvant chemoradiation (CROSS protocol) in adenocarcinoma of the oesophagus and oesophago-gastric junction

SCOPE 2 A randomised Phase II/III trial to study radiotherapy dose escalation in patients with oesophageal cancer treated with definitive chemo-radiation with an embedded Phase II trial for patients with a poor early response using positron emission tomography (PET)

PLATFORM PLAnning Treatment For Oesophago-Gastric Cancer: a Randomised Maintenance Therapy Trial

Ovarian Cancer

ROCkeTS Refining Ovarian Cancer Test Accuracy Scores: A test accuracy study to validate new risk scores in women with symptoms of suspected ovarian cancer protocol

NICCC A Randomised Phase II Study Of Nintedanib (BIBF1120) Compared To Chemotherapy In Patients With Recurrent Clear Cell Carcinoma Of The Ovary Or Endometrium

OCTOVA Randomised Phase II Trial of olaparib, chemotherapy or olaparib and cediranib in patients with BRCA mutated platinum–resistant ovarian cancer

Pancreatic Cancer

PIONEER A Phase I Study of Olaparib in combination with Chemo-radiation in Locally Advanced Pancreatic Cancer [ON HOLD]

Prostate Cancer

Stampede Systemic Therapy in Advancing or Metastatic Prostate cancer – Evaluation of Drug Efficacy

UKGPC UK Genetics Prostate Cancer Study

SPORT High-Risk Trial A Randomised Feasibility Study Evaluating Stereotactic Prostate Radio Therapy In High-Risk Localised Prostate Cancer With Or Without Elective Nodal Irradiation [ON HOLD]

Immune gene expression and tumour microenvironment in prostate cancer How does radiotherapy affect immune gene expression and the tumour microenvironment in men with localised prostate cancer?

RE-AKT A Randomised Phase II Study Of Enzalutamide (MDV3100) In Combination With AZD5363 In Patients With Metastatic Castration-Resistant Prostate Cancer

ACE Proof of concept Phase I/II trial of the CXCR2 antagonist AZD5069, administered in combination with enzalutamide, in patients with metastatic castration resistant prostate cancer

TrueNTH Global Registry Prostate Cancer Outcomes

INTERVAL (GAP 4) Intense Exercise For Survival Among Men with Metastatic Castrate-Resistant Prostate Cancer (Interval-MCRPC): A Multicentre, Randomised, Controlled III Study

Sarcoma

EURO Ewing 2012 International Randomised Controlled Trial for the Treatment of Newly Diagnosed Ewing’s Sarcoma Family of Tumours

Stomach/Gastro-oesophageal junction Cancer

PLATFORM PLAnning Treatment For Oesophago-Gastric Cancer: a Randomised Maintenance Therapy Trial

Studies not specific to one particular type of cancer

CaPP3 A randomised double blind dose non-inferiority trial of a daily dose of 600mg versus 300mg versus 100mg of enteric coated aspirin as a cancer preventive in carriers of a germline pathological mismatch repair gene defect, Lynch Syndrome. Project 3 in the Cancer Prevention Programme

EASI-SWITCH Early Switch to Oral Antibiotic Therapy in Patients with Low Risk Neutropenic Sepsis

CIBRAC Chemoprevention in BRCA1 Mutation Carriers – a Proof of Concept Study

A Phase I trial of LY3143921 hydrate in solid tumours A Cancer Research UK phase I trial of LY3143921 hydrate (a CDC7 inhibitor) given orally once daily in adult patients with advanced solid tumours

CORE A Randomised Trial Of Conventional Care Versus Radioablation (Stereotactic Body Radiotherapy) For Extracranial Oligometastases

NuTide:301 A two-part, phase I open label, dose escalation and expansion study to assess safety, pharmacokinetics and clinical activity of NUC- 3373, A nucleotide analoguw, in participants with advanced Solid Tumours

CellCentric CCS1477-01 An open-label Phase I/IIa study to evaluate the safety and efficacy of CCS1477 as monotherapy and in combination in patients with advanced solid/metastatic tumours

Haematological Clinical Trials

Leukaemia

LI-1 A Programme Of Development For Older Patients With Acute Myeloid Leukaemia And High Risk Myelodysplastic Syndrome

UKALL 14 A randomised trial for adults with newly diagnosed acute lymphoblastic leukaemia

FLAIR Front-Line therapy in CLL: Assessment of Ibrutinib + Rituximab [ON HOLD CRAIGAVON]

AML19 Adults with Acute Leukaemia or High Risk Myelodysplastic Syndrome

UKALL 2011 United Kingdom National Randomised Trial for Children and Young Adults with Acute Lymphoblastic Leukaemia and Lymphoma 2011

AML 18 A Trial For Older Patients With Acute Myeloid Leukaemia And High Risk Myelodysplastic Syndrome

Lymphoma

MaPLe Molecular Profiling for Lymphoma Study (also available in the Ulster Hospital)

UKALL 2011 United Kingdom National Randomised Trial for Children and Young Adults with Acute Lymphoblastic Leukaemia and Lymphoma 2011

Multiple Myeloma

C16021 A Phase 3, Randomized, Placebo-Controlled, Double-Blind Study of Oral Ixazomib Maintenance Therapy After Initial Therapy in Patients With Newly Diagnosed Multiple Myeloma Not Treated With Stem Cell Transplantation (available at Ulster Hospital only) [ON HOLD ULSTER]

CEPHEUS A Phase 3 Study Comparing Daratumumab, VELCADE (bortezomib), Lenalidomide, and Dexamethasone (D-VRd) with VELCADE, Lenalidomide, and Dexamethasone (VRd) in Subjects with Untreated Multiple Myeloma and for Whom Hematopoietic Stem Cell Transplant is Not Planned as Initial Therapy

Other Haematological

Expanded PNH Registry Paroxysmal Nocturnal Haemoglobinuria (PNH) Registry [ON HOLD]

TREATT Trial To Evaluate Tranexamic Acid Therapy In Thrombocytopenia. A Double Blind, Randomised Controlled Trial Evaluating The Safety And Efficacy Of Tranexamic Acid In Patients With Haematological Malignancies With Severe Thrombocytopeni

TAMARIN Effects of TAMoxifen on the Mutant Allele Burden And Disease Course In Patients With Myeloproliferative Neoplasms [ON HOLD]

AML 18 A Trial For Older Patients With Acute Myeloid Leukaemia And High Risk Myelodysplastic Syndrome

Idopathic Cytopenia Improving diagnosis in idiopathic cytopenia using gene sequencing

ENABLE-NGS Enabling diagnosis in chronic B-cell lymphoproliferative disorders using Next-Generation Sequencing

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