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.
THE NICTN OPEN CLINICAL TRIALS LIST
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
Melanoma
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
Leukaemia
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
Lymphoma
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
