Portfolio – Open Trials

Northern Ireland Cancer Trials Network

Belfast Experimental Cancer Medicine Centre

 TRIALS OPEN TO RECRUITMENT – 

September 2022

Anyone who wishes to consider participation in a cancer clinical trial should discuss this with their own treating doctor.

COVID-19 update: NICTN is currently working to re-activate recruitment to studies, where this is feasible and safe.  

THE NICTN OPEN CLINICAL TRIALS LIST

Bilary Tract Cancer

PORCUPINE-2 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

IMvigor011 Phase Iii, Double-Blind, Multicenter, Randomized Study Of Atezolizumab (Anti-Pd-L1 Antibody) Versus Placebo As Adjuvant Therapy In Patients With High-Risk Muscle-Invasive Bladder Cancer Who Are ctDNA Positive Following Cystectomy

Bowel Cancer

PROMETCO A real world prospective cohort study in the management of metastatic colorectal cancer: a clinical and patient perspective

ARC-9 A Phase 1b/2, Open-Label, Randomized Platform Study Evaluating the Efficacy and Safety of AB928-Based Treatment Combinations in Patients with Metastatic Colorectal 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

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 

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

ANTHEM Trial The ANTHEM Feasibility Study, Is A Novel THErapeutic mammaplasty procedure a safe and effective alternative to Mastectomy for treatment of breast cancer?

KEYNOTE-B49 A Randomised, 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, post authorisation 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

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

RANGO Rare Neoplasms of Gynaecological Origin

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

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

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

Endometrial (Womb) Cancer

RANGO Rare Neoplasms of Gynaecological Origin

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

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”

SARON Stereotactic ablative radiotherapy for oligometastatic non-small cell lung cancer. A randomised phase III trial [ON HOLD]

Melanoma

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

Oesophageal 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

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

ICHOR Investigation of Circulating Haematological Biomarkers in Cancer [ON HOLD]

Ovarian Cancer

RANGO Rare Neoplasms of Gynaecological Origin

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 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

Stampede Systemic Therapy in Advancing or Metastatic Prostate cancer – Evaluation of Drug Efficacy [ON HOLD]

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

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]

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

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

Lantern Pharma Biomarker analysis using fresh biopsy tissue [ON HOLD]

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

AMPLITUDE A Phase 3 Randomized, Placebo-controlled, Double-blind Study of Niraparib in Combination with Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for the Treatment of Participants with Deleterious Germline or Somatic Homologous Recombination Repair (HRR) Gene-Mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC)

TRAP Targeted Radiotherapy in Androgen-suppressed Prostate cancer patients

Sarcoma

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

Vulval Cancer

RANGO Rare Neoplasms of Gynaecological Origin

Studies not specific to one particular type of 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

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

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

DIAdIC Protocol for an International Randomized Controlled Trial to evaluate the effectiveness of a nurse-delivered (FOCUS+) and a web-based (iFOCUS) psychoeducational intervention for people with Advanced cancer and their family caregivers

TARGET National Tumour Characterization to Guide Experiential Targeted Therapy – National (Paused)

TOASTIE Tolerance Of Anti-cancer Systemic Therapy In the Elderly

E-StOIC  An Observational Study of Diagnostic Criteria, Clinical Features and Management of Opioid-Induced Constipation (OIC) in Patients with Cancer Pain

Haematological Clinical Trials

Leukaemia

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

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 + Rituximab

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

Multiple Myeloma

Other Haematological

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

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

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