Northern Ireland Cancer Trials Network
Belfast Experimental Cancer Medicine Centre
TRIALS OPEN TO RECRUITMENT –
June 2020
COVID-19 update: NICTN is currently working to re-activate recruitment to studies, where this is feasible and safe. Anyone who wishes to consider participation in a cancer clinical trial should discuss this 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 [ON HOLD]
Bowel Cancer
NSCCG National Study Of Colorectal Cancer Genetics [ON HOLD]
BALLAD UK A trial to evaluate the potential benefit of adjuvant chemotherapy for small bowel adenocarcinoma [ON HOLD]
CReST 2 Colorectal Stenting Trial 2 – Uncovered and Covered Endoluminal Stenting in the acute management of obstructing colorectal cancer in the palliative setting [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 [ON HOLD]
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 [ON HOLD]
FOCUS 4 Molecular Selection Of Therapy In Colorectal Cancer: A Molecularly-Stratified Randomised Controlled Trials Programme [ON HOLD]
ALLEGRO A placebo controlled randomised trial of intravenous lidocaine in accelerating gastrointestinal recovery after colorectal surgery [ON HOLD]
Brain Tumours
ROAM Radiation Versus Observation Following Surgical Resection Of Atypical Meningioma: A Randomised Controlled Trial [ON HOLD]
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
LORIS A Phase III Trial of Surgery versus Active Monitoring for Low Risk Ductal Carcinoma in Situ (DCIS) [ON HOLD]
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 [ON HOLD]
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 [ON HOLD]
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) [ON HOLD]
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 [ON HOLD]
PRIMETIME Post-operative avoidance of radiotherapy in minimal risk women: patient selection using biomarkers
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 [ON HOLD]
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 [ON HOLD]
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
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
IMAT Neuroblastoma A randomised phase I/II study of Intensity Modulated Arc Therapy techniques in abdominal neuroblastoma
LCH-IV International Collaborative Treatment Protocol for Children and Adolescents with Langerhans Cell Histiocytosis
PHITT Paediatric Hepatic International Tumour Trial
BEACON A Randomised Phase IIb Trial Of Bevacizumab Added to Temozolomide + Irinotecan For Children With Refractory / Relapsed Neuroblastoma
SMP Paeds: Stratified Medicine Paediatrics: Genomic Characterisation Of Relapsed Paediatric Cancers For Diagnostics And Stratified Therapy [ON HOLD]
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 [ON HOLD]
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 [ON HOLD]
COMPARE Phase III randomised controlled trial Comparing Alternative Regimens for escalating treatment of intermediate and high-risk oropharyngeal cancer
Haematological Cancers (see below)
Liver Cancer
COSMIC 312 A Randomized, Controlled Phase 3 Study of Cabozantinib (XL184) in Combination with Atezolizumab versus Sorafenib in Subjects with Advanced Hepatocellular Carcinoma Who Have Not Received Previous Systemic Anticancer Therapy [ON HOLD]
Lung Cancer
Stratified Medicine Programme 2 Cancer Research UK Stratified Medicine Programme 2 [ON HOLD]
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 [ON HOLD]
SYSTEMS-2 A Randomised Phase II Trial of Standard Versus Dose Escalated Radiotherapy in the Treatment of Pain in Malignant Pleural Mesothelioma [ON HOLD]
SARON Stereotactic ablative radiotherapy for oligometastatic non-small cell lung cancer. A randomized phase III trial. [ON HOLD]
KEYNOTE-598 A Phase 3, Randomized, Double-Blind Study of Pembrolizumab plus Ipilimunab plus Placebo in Previously Untreated, Stage IV, Metastatic Non-small Cell lung Cancer Subjects Whose Tumors are PD-L1 Postive (TPS ≥ 50%) [ON HOLD]
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 [ON HOLD]
HALT Lung cancer “Targeted therapy with or without dose intensified radiotherapy for oligo-progressive disease in oncogene-addicted lung tumours” [ON HOLD]
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) [ON HOLD]
PROFILES bnP for pRediction of Outcome FollowIng Lung rEsection Surgery [ON HOLD]
ADSCAN A Randomised Phase II study of Accelerated, Dose escalated, Sequential Chemo-radiotherapy in Non-Small Cell Lung Cancer [ON HOLD]
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 [ON HOLD]
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 [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 [ON HOLD]
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 [ON HOLD]
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) [ON HOLD]
PLATFORM PLAnning Treatment For Oesophago-Gastric Cancer: a Randomised Maintenance Therapy Trial [ON HOLD]
ICHOR Investigation of Circulating Haematological Biomarkers in Cancer [ON HOLD]
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 [ON HOLD]
Pancreatic Cancer
PIONEER A Phase I Study of Olaparib in combination with Chemo-radiation in Locally Advanced Pancreatic Cancer [ON HOLD]
SCALOP 2 A multi-centre randomised study of induction chemotherapy followed by capecitabine (+/-nelfinavir) with high or standard dose radiotherapy for locally advanced non-metastatic pancreatic cancer [ON HOLD]
Precision-Panc Master Protocol Personalising Treatment For Pancreatic Cancer [ON HOLD]
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 [ON HOLD]
Prostate Cancer
Stampede Systemic Therapy in Advancing or Metastatic Prostate cancer – Evaluation of Drug Efficacy [ON HOLD]
UKGPC UK Genetics Prostate Cancer Study [ON HOLD]
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? [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 [ON HOLD]
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
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 [ON HOLD]
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 [ON HOLD]
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 [ON HOLD]
PLATFORM PLAnning Treatment For Oesophago-Gastric Cancer: a Randomised Maintenance Therapy Trial [ON HOLD]
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
CIBRAC Chemoprevention in BRCA1 Mutation Carriers – a Proof of Concept Study [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 [ON HOLD]
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 [ON HOLD]
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 [ON HOLD]
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 [ON HOLD]
UK P3BEP A randomized phase 3 trial of accelerated versus standard BEP chemotherapy for patients with intermediate and poor-risk metastatic germ cell tumours [ON HOLD]
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 [ON HOLD]
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 [ON HOLD]
UKALL 2011 United Kingdom National Randomised Trial for Children and Young Adults with Acute Lymphoblastic Leukaemia and Lymphoma 2011
ENRICH A randomised, open label study of rituximab + ibrutinib (IR) vs rituximab + chemotherapy (R-Chemo) in older patients with untreated mantle cell lymphoma. Primary objective is to assess whether IR is superior to R-Chemo in terms of progression-free survival (PFS)
ME-401 A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Two-Arm, Phase 2 Study of ME-401 in Subjects with Follicular Lymphoma After Failure of Two or More Prior Systemic Therapies [ON HOLD]
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 [ON HOLD]
Other Haematological
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 Thrombocytopenia
AML 18 A Trial For Older Patients With Acute Myeloid Leukaemia And High Risk Myelodysplastic Syndrome
Idiopathic Cytopenia Improving diagnosis in idiopathic cytopenia using gene sequencing [ON HOLD]
ENABLE-NGS Enabling diagnosis in chronic B-cell lymphoproliferative disorders using Next-Generation Sequencing [ON HOLD]
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)
