Portfolio – Open Trials

Northern Ireland Cancer Trials Network

Belfast Experimental Cancer Medicine Centre

 TRIALS OPEN TO RECRUITMENT – May 2018

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

MERCURY 2 Low Rectal Cancer Study

ARISTOTLE A phase III trial comparing standard versus novel CRT as pre-operative treatment for MRI defined locally advanced rectal cancer

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

MErCuRIC1  A Phase I study of MEK1/2 inhibitor PD-0325901 with cMET inhibitor PF-02341066 in RASMT and RASWT (with aberrant c-MET) Colorectal Cancer Patients

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

MAMMO-50 Mammographic surveillance in breast cancer patients aged 50 years or older (available in Antrim and Craigavon hospitals)

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

FAST-Forward Lymphatic RT Sub-Study FAST-Forward 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 patients with early breast cancer (Note recruitment on hold 06.12.17)

HORIZONS A cohort study to explore recovery of health and well-being in adults diagnosed with cancer

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

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

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

FAST-Forward Lymphatic RT Sub-Study FAST-Forward 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 patients with early breast cancer

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 

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

HORIZONS A cohort study to explore recovery of health and well-being in adults diagnosed with 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

CNS GCT II Prospective Trial For The Diagnosis And Treatment Of Children, Adolescents and Young Adults With Intracranial Germ Cell Tumours

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

EuroNet PHL-LP1 First international Inter-Group Study for nodular lymphocyte-predominant Hodgkin’s Lymphoma in Children and Adolescents

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

FACT Factors Associated with Childhood Tumours Study

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

Endometrial (womb) Cancer

HORIZONS A cohort study to explore recovery of health and well-being in adults diagnosed with cancer

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

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

Oesophageal Cancer

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

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

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

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

ORZORA An Open-Label, Single-Arm, Multicentre Study To Assess The Clinical Effectiveness And Safety Of Lynparza (Olaparib) Capsules Maintenance Monotherapy In Platinum Sensitive Relapsed BRCA Mutated Ovarian Cancer Patients Who Are In Complete Or Partial Response Following Platinum Based Chemotherapy

HORIZONS A cohort study to explore recovery of health and well-being in adults diagnosed with cancer

Pancreatic Cancer

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

Prostate Cancer

UKGPC UK Genetics Prostate Cancer Study

TOPARP Phase II Trial of Olaparib in Patients with Advanced Castration Resistant Prostate Cancer

ADRRAD Neo-adjuvant Androgen Deprivation Therapy, Pelvic Radiotherapy and RADium-223 for new presentation T1-4 N0/1 M1B adenocarcinoma of prostate

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

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

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

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

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

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

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

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

SINCERE A single-centre, assessor blind, randomised pilot study to evaluate the safety, tolerability and acceptability of RB Lotion compared to standard-of-care for Radiation Induced Skin Reactions (RISR), in subjects undergoing palliative external beam Radiotherapy (RT)

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

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

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

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

HORIZONS A cohort study to explore recovery of health and well-being in adults diagnosed with cancer

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

IcICLLe Assessment of the Mechanism of Action of Ibrutinib (PCI-32765) in B-cell Receptor Pathway Inhibition in Chronic Lymphocytic Leukaemia (CLL)

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

CALiBRe Assessment of the Mechanism of Action of idelalisib (CAL101) in B-cell Receptor Pathway Inhibition in CLL

Genomic and epigenetic analysis of AML and MDS

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

Lymphoma

MaPLe Molecular Profiling for Lymphoma Study

ARROVEN Post-Authorisation Safety Study (PASS) MA25101: An Observational Cohort Study of the Safety of Brentuximab Vedotin in the Treatment of Relapsed or Refractory CD30+ Hodgkin Lymphoma and Relapsed or Refractory Systemic Anaplastic Large Cell Lymphoma

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

HORIZONS A cohort study to explore recovery of health and well-being in adults diagnosed with cancer

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

Other Haematological

Expanded PNH Registry Paroxysmal Nocturnal Haemoglobinuria (PNH) Registry

MEASURES The Myeloproliferative Neoplasms Quality of Life (MPN-QOL) International Study Group

ELASTIC  A phase Ib study of Eltrombopag and Azacitidine in patients with high risk myelodysplastic syndomes and related disorders

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

Genomic and epigenetic analysis of AML and MDS

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