Portfolio – Open Trials

Northern Ireland Cancer Trials Network

 Belfast Experimental Cancer Medicine Centre

 Trials Open to Recruitment – April 2023

Anyone considering participation in a clinical trial should discuss this with their own treating doctor.


Biliary Tract Cancer

PORCUPINE 2 STUDY A Modular, Phase II, Open-Label, Multicentre Study to Assess the Preliminary Efficacy and Safety of RXC004, in Patients with Advanced Solid Tumours that have Progressed following Therapy with Current Standard of Care

Bladder Cancer

Bowel Cancer

DRAGON 1 Training, Accreditation, Implementation And Safety Evaluation Of Portal and Hepatic Vein Embolization (PVE/HVE) To Accelerate Future Liver Remnant (FLR) Hypertrophy

 Brain Tumours

Breast Cancer

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

ROSCO Response To Optimal Selection Of Neo-Adjuvant Chemotherapy In Operable Breast Cancer

PEARL A window of opportunity study to assess the biological effects of progesterone in premenopausal ER-positive, PgR-positive early breast cancer [ON HOLD]

SMALL A Phase III, randomised, multi-centre trial addressing overtreatment of small screen-detected breast cancer by comparing standard surgery versus minimally invasive vacuum-assisted excision   

NOSTRA A prospective, non-randomised, multi-centre feasibility study to assess if patients residual cancer following dual-targeted neoadjuvant chemotherapy treatment for HER2-positive, ER-negative early breast cancer can be identified by multiple ultrasound-guided tumour bed core biopsies

ASTEFANIA A phase III, randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of adjuvant atezolizumab or placebo and trastuzumab emtansine for her2-positive breast cancer at high risk of recurrence following preoperative therapy

RESTORE-C19 Exploring the experiences and outcomes of patients not offered immediate breast REconstruction after maSTectOmy for bREast cancer during the COVID-19 pandemic

KEYNOTE-B49 A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Pembrolizumab Plus Chemotherapy Versus Placebo Plus Chemotherapy for the Treatment of Chemotherapy-Candidate Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative (HR+/HER2-) Metastatic Breast Cancer

The NERLYFE Study Multicenter, multi-country, prospective, observational, postauthorisation safety study to describe the incidence of discontinuation due to diarrhoea within the first 3 months of treatment with neratinib, in adult breast cancer patients treated in extended adjuvant in a real world setting: the NERLYFE study. Ancillary study: A Nerlyfe ancillary study to describe recurrence in breast cancer patients treated with neratinib in a real-world setting

POETIC-A Pre-Operative Endocrine Therapy for Individualised Care with Abemaciclib

IMPARTER:4 IMproving PAtient undeRstanding of GEP TEst Results: Phase 4

MARECA National study of management of breast cancer locoregional recurrence and oncologic outcome

Cervical Cancer

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

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

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

Ewing’s 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 (PK 2013 01)

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

SMP Paeds Stratified Medicine Paediatrics: Genomic Characterisation Of Relapsed Paediatric Cancers For Diagnostics And Stratified Therapy

Childhood Cancer Diagnosis The Childhood Cancer Diagnosis Study: understanding the pathway to diagnosis

ENHANCE Experience of end of life care—Workstream 2 of End of life Care for Infants, Children and Young People: a mixed methods evaluation of current practice in the UK

Germ Cell Tumours

UK P3BEP A randomized phase 3 trial of accelerated versus standard BEP chemotherapy for patients with intermediate and poor-risk metastatic germ cell tumours

Gynaecological Cancers (rare)

RaNGO Rare Neoplasms of Gynaecological Origin

Head and Neck Cancer

iNATT The interNational Anaplastic Thyroid Cancer Tissue Bank and Database Project

COMPARE Phase III randomised controlled trial Comparing Alternative Regimens for escalating treatment of intermediate and high-risk oropharyngeal cancer

Haematological Cancers (see below)

Kidney Cancer

Liver Cancer

Lung Cancer

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

CONCORDE A platform study of DNA damage response inhibitors in combination with conventional radiotherapy in non-small cell lung cancer

PACIFIC-9 A Phase III, double-blind, placebo-controlled, Randomized, Multicentre, International Study of Durvalumab Plus Oleclumab and Durvalumab Plus Monalizumab in Patients with Locally Advanced (Stage III), Unresectable, Non-small Cell Lung Cancer (NSCLC) Who Have Not Progressed Following Definitive , Platinum-Based Concurrent Chemoradiation Therapy


Oesophageal Cancer

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

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

SCOPE2  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

ICHOR Investigation of Circulating Haematological Biomarkers in Cancer

 Ovarian Cancer

PROTECTOR Preventing Ovarian Cancer through Early Excision of Tubes and late Ovarian Removal

MONITOR-UK Multi-Centre Observational study of Maintenance Niraparib in Treatment of Ovarian CanceR: UK routine clinical practice experience

Pancreatic Cancer

Precision-Panc Master Protocol Personalising Treatment For Pancreatic Cancer

PRIMUS-001 An adaptive phase II study of FOLFOX-A (FOLFOX and nab-paclitaxel) versus AG (nab-paclitaxel and gemcitabine) in patients with metastatic pancreatic cancer, with integrated biomarker evaluation

PORCUPINE 2 STUDY A Modular, Phase II, Open-Label, Multicentre Study to Assess the Preliminary Efficacy and Safety of RXC004, in Patients with Advanced Solid Tumours that have Progressed following Therapy with Current Standard of Care

Prostate Cancer

UKGPC UK Genetics Prostate Cancer Study

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? [ON HOLD]

Lantern Pharma Biomarker analysis using fresh biopsy tissue (only available in Altnagelvin Hospital) [ON HOLD]

Pivotal Boost A Phase III Randomised Controlled Trial of Prostate and Pelvis Versus Prostate Alone Radiotherapy With Or Without Prostate Boost

DASL-HiCaP Darolutamide Augments Standard Therapy for Localised Very High-Risk Cancer of the Prostate (ANZUP1801). A randomised phase 3 double-blind, placebo-controlled trial of adding darolutamide to androgen deprivation therapy and definitive or salvage radiation in very high risk, clinically localised prostate cancer

PSMAddition An International Prospective Open-Label, Randomised, Phase 3 Study Comparing 177Lu-PSMA-617 In Combination With Standard of Care, Versus Standard Of Care Alone, In Adult Male Patients With Metastatic Hormone Sensitive Prostate Cancer

PACE-NODES A phase III randomized trial of 5 fraction prostate SBRT versus 5 fraction prostate and pelvic nodal SBRT

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

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

Urothelial Cancer

RE-ARM A Randomised phase II trial of Enhancement of efficacy of Atezolizumab by Radiotherapy in Metastatic urothelial carcinoma

Studies not specific to a particular type of cancer

CellCentric 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  

TARGET National Tumour Characterization to Guide Experiential Targeted Therapy –National

TOASTIE Tolerance Of Anti-cancer Systemic Therapy In the Elderly


Haematological Clinical Trials


PACE Patients with AML and COVID-19 Epidemiology [ON HOLD]

VICTOR Venetoclax or Intensive Chemotherapy For Treatment of Favourable Risk Acute Myeloid Leukaemia:  A Molecularly Guided Phase 2 Study

M19-708 / VIALE-M Randomized, Open-Label, 2-Arm, Multicenter, Phase 3 Study Of Venetoclax and Azacitidine Versus Best Supportive Care As Maintenance Therapy For Patients With Acute Myeloid Leukemia In First Remission After Conventional Chemotherapy


FLAIR Front-Line therapy in CLL: Assessment of Ibrutinib containing Regimes) [ON HOLD]

STELLAR A phase II, randomiSed study of CHOP-R in combination with acalabruTinib comparEd to CHOP-R in patients with newLy diagnosed Richter’s Syndrome and a pLAtfoRm for initial investigations into activity of novel treatments in relapsed/refractory and newly diagnosed Richter’s Syndrome

Pola-R-ICE An open-label, prospective Phase III clinical study to compare polatuzumab vedotin plus rituximab, ifosfamide, carboplatin and

etoposide (Pola-R-ICE) with rituximab, ifosfamide, carboplatin and etoposide (R-ICE) alone as salvage therapy in patients with primary refractory or relapsed diffuse large B-cell lymphoma (DLBCL)


Multiple Myeloma

Other Haematological

Manifest A Phase 1/2 Study of CPI-0610, a Small Molecule Inhibitor of BET

Proteins: Phase 1 (Dose Escalation of CPI-0610 in Patients with Haematological Malignancies) and Phase 2 (Dose Expansion of CPI-0610 with and without Ruxolitinib in Patients with Myelofibrosis)

Promise Investigation Into The Combination Of PLX2853 With Ruxolitinib In Patients With Intermediate-2 Or High Risk Myelofibrosis Not Receiving An Adequate Response With Ruxolitinib Alone

FEDORA A Phase II Study To Evaluate The Tolerability, Safety And Activity Of Fedratinib Combined With Ropeginterferon Alfa-2b In Patients With Myelofibrosis

MOSAICC MyeloprOliferative NeoplasmS An In-Depth Case-Control Study:  A Case-Control Study Of Patients With Myeloproliferative Neoplasms And Non-Blood Relative/Friend Controls