Cancer trials

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The CRCTU has been designing and delivering cancer trials for over 40 years. Working in both paediatric and adult settings, the Unit collaborates with a large number of investigators both at a national and international level.

The CRCTU have developed a number of national initiatives over the years including the TAP and IMPACT networks and it is Cancer Research UK's dedicated clinical trials unit for children's cancers. The Unit has a strong track record of delivering breast, haematological and paediatric cancer trials. Other strategic disease sites include lung, head and neck, and brain cancers.

Brain and central nervous cancer

  • BPA: A Cancer Research UK pharmacokenetic study of p-boronophenylalanine (BPA) in patients with high glioma of optimise uptake paramaters for clinical trials of boron neutron capture therapy
  • BSG: A phase II multi-centre study of concomitant and prolonged adjuvant temozolomide with radiotherapy in diffuse pontine gliomas
  • CPT: CPT-SIOP-2009: Intercontinental Multidisciplinary Registry and Treatment Optimization Study for Patients with Choroid Plexus Tumors
  • HART: Hyperfractionated Accelerated Radiotherapy (hart) with chemotherapy (cisplatin, ccnu, vincristine)
    for metastatic (m1-3) medulloblastoma (CNS 2001 06)
  • Infant Brain: Management of children aged less than 3 years with a brain tumour (CNS 9204)
  • INTREPID: A phase I dose escalation study of intrathecal Etoposide as a continuous infusion investigating duration and rate of infusion in patients with leptomeningeal metastatic brain cancer
  • LGG2: Cooperative multicenter Study for Children and Adolescents with Low Grade Glioma SIOP-LGG 2004
  • LowGrade Glioma: Low Grade Glioma (CNS 1997 02)
  • PNET 4: A prospective randomised controlled trial of hyperfractionated versus conventionally fractionated radiotherapy in standard risk medulloblastoma
  • Tessa Jowell Brain Matrix: The Tessa Jowell BRAIN MATRIX is a first-of-its-kind clinical trial platform that will enable researchers to collect a rich genomic, pathological and imaging dataset to provide patients and clinicians with a fully integrated diagnosis of their disease. The end goal of this platform is to accelerate the development and delivery of brain tumour clinical trials and provide greater access to novel targeted treatments and improved outcomes for patients, both in terms of survival and quality of life.

Breast cancer

  • ABC: Adjuvant Breast Cancer trial: UKCCCR randomised trial of adjuvant endrocrine therapy and chemotherapy in women with early breast cancer.
  • aTTom: Adjuvant Tamoxifen Treatment Offer More: - to assess the reliably balance of benefits and risk of prolonging adjuvant tamoxifen treatment by 5 years for women with breast cancer.
  • AZURE: Does Adjuvant Zoledronic acid redUce REcurrence in patients with high-risk, localised breast cancer?
  • BR3002: Adjuvant radiotherapy and tamoxifen in conservative management of early breast cancer.
  • Cambridge Breast Cancer Trial: Investigations of radiotherapy dose inhomogeneity and cosmetic outcome in pateints with early breast cancer: a randomised controlled trial.
  • LORIS: A Phase III trial of surgery versus active monitoring for low risk Ductal Carcinoma in Situ (DCIS).
  • NEAT: National breast cancer study of epirubicin plus CMF versus classical CMF aduvant therapy.
  • NEAT-A: A multicentre Phase II feasibility study of accelerated chemotherapy - sequential epirubicin followed by IV CMF - using pegfilgrastim for women with early stage breast cancer.
  • NEO-EXCEL: Neoadjuvant trial of pre-operative exemestane or letrozole +/- celecoxib in the treatment of ER positive postmenopausal early breast cancer.
  • Neo-tAnGo: A neoadjuvant study of sequential epirubicin + cyclophosphamide and paclitaxel ± gemcitabine in the treatment of high risk early breast cancer with molecular profiling and candidate gene analysis
  • PG-SNPs: The pharmacogenetics of early breast cancer chemotherapy
  • PHAB-PILOT: Physical activity and breast cancer - pilot research protocol
  • PHATE: The level of physical activity in women attending breast cancer follow up clinic
  • ROSCO: Response to Optimal Selection of neo-adjuvant Chemotherapy in Operable breast cancer
  • SECRAB: Sequencing of Chemotherapy and Radiotherapy in Adjuvant Breast cancer
  • TACT2: Trial of Accelerated adjuvant ChemoTherapy with capecitabine in early breast cancer
  • tAnGo: A randomised phase III trial of gemcitabine in paclitaxel-containing epirubicin based adjuvant chemotherapy for women with early stage breast cancer
  • TEAM: An open label randomised multicentre comparative trial of 5 years adjuvant exemestane treatment versus adjuvant tamoxifen followed by exemestane in postmenopausal women with early stage breast cancer

Colorectal cancer

ANICCA-ClassII: A Phase II trial assessing nivolumab in stron class II expressing microsatellite stable colorectal cancer

Haemotology

  • ALCL 99: International protocol for the treatment of Childhood Anaplastic Large Cell Lymphoma (ALCL 99)
  • ALCL Relapse: Treatment protocol for relapsed anaplastic large cell lymphoma of childhood of childhood and adolescence (NHL 2006 01)
  • AZTEC: A phase II study of the use of azacitidine for the treatment of patients with chronic graft-versus-host-disease who have failed therapy with corticosteroids
  • BaP: Single arm phase II trial assessing the safety, compliance with and activity of Bezafibrate and medroxyProgesterone acetate (BaP) therapy against myeloid and lymphoid cancers
  • BREVITY: A phase II study of brentuximab vedotin (SGN-35) using a responce adapted design in patients with Hodgkin lymphoma unsuitable for chemotherapy due to age, frailty or co-morbidity
  • Bubble: Phase 1B Study of buparlisib with Bortezomib in Defined Genetic Subgroups of Patients with Relapsed or Refractory Multiple Myeloma
  • CALiBRe: Assessment of the mechanism of action of CAL-101 in B-cell receptor pathway inhibition in CLL
  • CLARITY: Assessment of Venetoclax (ABT-199) in combination with Ibrutinib in relapsed/refractory Chronic Lymphocytic Leukaemia
  • CLL pathogenesis: Study of the pathogenesis of Chronic Lymphocytic Leukaemia
  • CTAg: Study of the immune response to haematological malignancies
  • CyCLLe: An phase II trial of Cyclosporin A in early adverse risk CLL
  • De-Iron: A phase 2 study of the efficacy and safety of Deferasirox administered at early iron loading in patients with transfusion-dependent Myelodysplastic Syndromes
  • ELASTIC: A phase Ib study of Eltrombopag and Azacitidine in patients with high risk myelodysplastic syndromes and related disorders
  • Euro LB 02: Treatment Protocol for T-Cell and B-Precursor Cell Lymphoblastic Lymphoma of the European inter-group Co-operation on Childhood Non-Hodgkin-Lymphoma (EICNHL)
  • FIGARO: A Randomised Trial of the FLAMSA-BU Conditioning Regimen in Patients with Acute Myeloid Leukaemia and Myelodysplasia Undergoing Allogeneic Stem Cell Transplantation
  • HA-1: A phase I clinical trial of the vaccination of healthy human volunteers against the minor histocompatibility antigen (mHAg) HA-1 using a DNA and MVA ‘prime/boost’ regimen
  • HD-3: United Kingdom Children’s Cancer Study Group (UKCCSG) protocol for the treatment of children and adolescents with Hodgkin’s disease
  • HLH 2004: Treatment protocol of the second international HLH study 2004 (LCH 2006 02)
  • IciCLLe: Assessment of the mechanism of action of PCI-32765 in B-cell receptor pathway inhibition in CLL
  • Immune reconst: A Study of Immune Reconstitution Following Stem Cell Transplant
  • Interfant 99: Intrenational collaborative treatment protocol for infants under one year with acute lymphoblastic leukaemia (LK 1999 05)
  • LCH 3: Treatment protocol of the third international study for Langerhans Cell Histiocytosis
  • LenaRIC: Phase II study of the adjunctive use of lenalidomide in patients undergoing reduced intensity conditioning allogeneic transplantation for multiple myeloma
  • MAJIC: A randomised study of best available therapy versus JAK inhibition in patients with high risk polycythaemia vera or essential thrombocythaemia who are resistant or intolerant to hydroxycarbamide
  • Matchpoint: MAnagement of Transformed CHronic myeloid leukaemia: POnatinib and INTensive chemotherapy: a feasibility study
  • MiniAlloGlivec: A phase I/II study of the use of glivec in patients undergoing reduced intensity allografting for chronic myeloid leukaemia
  • Myechild 01: 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
  • NECTAR: A Phase I trial of NECTAR (Nelarabine, Etoposide and cyclophosphamide in T-ALL relapse): A joint study of TACL and POETIC.
  • PICLLe: Phase I/II clinical trial to assess the efficacy and safety of olaparib, a PARP-inhibitor, in relapsed and refractory chronic lymphocytic leukaemia patients with an 11q deletion or ATM mutation and relapsed/refractory patients with T-prolymphocytic leukaemia and mantle cell lymphoma
  • PHAZAR: A phase Ib study to assess the safety and tolerability of oral Ruxolitinib in combination with 5-azacitidine in patients with advanced phase myeloproliferative neoplasms (MPN), including myelodysplastic syndromes (MDS) or acute myeloid leukaemia (AML) arising from MPN.
  • RAvVA: Phase II randomised trial of 5-azacitidine versus vorinostat in vombination with 5-azacitidine in patients with Acute Myeloid Leukaemia or High Risk Myelodysplastic Syndromes for intensive chemotherapy
  • RICAZA: Phase II study of the tolerability of adjunctive Azacitidine in patients undergoing reduced intensity allogeneic stem cell transplantation for Acute Myeloid Leukaemia
  • ROMAZA: Phase I trial of Romidepsin plus Azacitidine combination therapy in patients with newly diagnosed, relapsed or refractory Acute Myeloid Leukaemia ineligible forconventional chemotherapy
  • RomiCar: Phase I/II study to determine the maximum tolerated dose and activity of the combination of romidepsin and carfilzomib in relapsed or refractory peripheral T-cell lymphoma
  • SeluDex: International phase I/II expansion trial of the MEK inhibitor selumetinib in combination with dexamethasone for the treatment of relapsed/refractory RAS-pathway mutated paediatric and adult Acute Lymphoblastic Leukaemia
  • TIER: A Phase I/II Study of Thiotepa, Ifosphamide, Etoposide and Rituximab for the treatment of relapsed and refractory primary central nervous system lymphoma
  • TORCH: A phase II study to determine the safety and efficacy of the dual mTORC inhibitor AZD2014 and to investigate additional toxicities in combination with rituximab in relapsed/refractory Diffuse Large B cell Lymphoma (DLBCL)
  • TRICE: Phase I/II study of the adjunctive use of Nilotinib in patients undergoing reduced intensity allogeneic transplantation for Imatinib resistant or intolerant Chronic Myeloid Leukaemia
  • TYKI: An investigation into the immunomodulatory effects of tyrosine kinase inhibitors (imatinib, dasatinib and nilotinib) on patients with chronic myeloid leukaemia
  • val/aza: Phase II study of the tolerability and efficacy of the histone deacetylase inhibitor sodium valproate administered in conjunction with 5-azacitidine, Theophylline and ATRA (all trans retinoic acid) in patients with Acute Myeloid Leukaemia and High Risk Myelodysplasia
  • Valproate: Phase II study of the tolerability and efficacy of the histone deacetylase inhibitor Sodium Valproate in conjunction with ATRA (all trans retinoic acid) in patients with Acute Myeloid Leukaemia
  • VIOLA: A phase 1 trial of combined azacitidine and lenalidomide salvage therapy in patients with AML who relapse after allogeneic stem cell transplantation

Head and neck cancer

  • ArChIMEDEs: Accelerated Hypofractionation, Chemotherapy, Intensity Modulation and Evaluation of Dose Escalation in Oropharyngeal Cancer
  • CompARE: Phase III randomised controlled trial Comparing Alternative Regimens for escalating treatment of intermediate and high-risk oropharyngeal cancer
  • Oromouth: HPV prevalence in the mouth and oropharynx of the tonsillectomy population
  • PACIFIC: Phase Ib trial of Atu027 in Combination with Cisplatin, 5-FU and Cetuximab in Patients with Head and Neck Cancer
  • Wisteria: A Phase I trial of WEE1 inhibition with Chemotherapy and Radiotherapy as adjuvant treatment, and a Window of Opportunity trial with Cisplatin in Patients with Head and Neck Cancer

Lung cancer

  • BTOG2: A British Thoracic Oncology Group, multi-centre, phase III trial of Gemcitabine plus Cisplatin at 80mg/m versus Gemcitabine plus Cisplatin at 50mg/m versus Gemcitabine plus Carboplatin AUC 6 in stage IIIB/IV non-small cell lung cancer.
  • National Lung Matrix Trial: Multi-drug, genetic marker directed, non-comparative multicentre, multi-arm Phase II trial in Non-Small Cell Lung Cancer
  • NOURISH P2: Improving the management of cachexia in patients with advanced lung cancer: Does the introduction of  beta-hydroxy-beta-methylbutyrate supplementation improve nutritional status and quality of life?
  • PePS2: A phase II trial of pembrolizumab in patients with non-small cell lung cancer and a performance status of 2
  • SPECIAL: Does early referral of patients with metastatic non-small cell lung cancer to UK specialist palliative care
    services make a difference in their quality of life or survival?
  • STOMP: Small cell lung cancer trial of Olaparib (AZD2281) as maintenance programme: a randomised, double blind, multicentre phase II trial

Paediatric cancer

  • AGCT 1513: A phase 3 study of active surveillance for low risk and a randomized trial of carboplatin vs. cisplatin for standard risk pediatric and adult patients with germ cell tumors
  • BEACON: A randomized phase IIb trial of BEvACizumab added to Temozolomide ± IrinOtecan for children with refractory/relapsed Neuroblastoma - BEACON-Neuroblastoma Trial
  • Biomede: Biological medicine for Diffuse Intrinsic Pontine Glioma (DIPG) eradication
  • CLOUD: Phase I dose escalation study of Clofarabine and Liposomal Daunorubicin in childhood and adolescent AML
  • CRISP: A phase 1B of crizotinib either in combination or as single agent in pediatric patients with ALK, ROS1 or MET positive malignancies Study ITCC 053
  • EE2012: Euro Ewing 2012 - International randomised controlled trial for the treatment of newly diagnosed Ewing's sarcoma family of tumours
  • Ependymoma II: An International Multi Centre Clinical Program for the diagnosis and treatment of children, adolescents and young adults with  Ependymoma
  • ESMART: European proof-of-concept therapeutic stratification trial of molecular anomalies in relapsed or refrctory tumours
  • EuroNet PHL-C1: First International Inter-Group Study for Classical Hodgkin’s Lymphoma in Children and Adolescents
  • EuroNet PHL-LP1: First International Inter-Group Study for Nodular Lymphocyte Predominant Hodgkin’s Lymphoma in Children and Adolescents
  • FaR-RMS is an over-arching study for children and adults with newly diagnosed and relapsed rhabdomyosarcoma (RMS). It is a multi-arm, multi-stage trial, involving several different questions.
  • GD2: A Phase I/II dose schedule finding study of ch14.18/CHO continuous infusion combined with subcutaneous aldesleukin (IL-2) in patients with primary refractory or relapsed neuroblastoma
  • Gotham: Phase II trial to assess the activity of Gemtuzumab Ozogamicin Therapy in HAemophagocytic lymphohistiocytosis (HLH) or Macrophage activation syndrome (MAS) or relapsed/refractory solid tumours
  • HRNBL
  • IMAT
  • Inter B NHL2010: Intergroup trial for children or adolescents with B-Cell NHL or B-AL: evaluation of rituximab in high risk patients
  • Interfant 06: International collaborative treatment protocol for infants under one year with acute lymphoblastic or biphenotypic leukaemia
  • LCHIV
  • LUDO: A phase IIa study of 177 Lutetium dotateate in children with primary refractory or relapsed high risk neuroblastoma
  • NivoALCL: Phase II trial of nivolumab for pediatric and adult relapsing/refractory ALK+ anaplastic large cell lymphoma, for evaluation of responde in patients with progressive disease (Cohort 1) or as consolidative immunotherapy in patients in complete remission after relapse (Cohort 2)
  • PARC: A Phase I/II study evaluating the safety and activity of Pegylated recombinant human Arginase (BCT-100) in Relapsed/refractory Cancers of Children and young adults
  • PNET5: An international prospective study on clinically standard-risk medulloblastoma in children with low-risk biological profile (PNET5 MB-LR) or average-risk biological profile (PNET5 MB-SR)
  • RMS 2005: A protocol for non metastatic rhabdomyosarcoma
  • SIOP CNS GCT ll
  • SIOP HRMB: An international prospective study on clinically high-risk medulloblastoma in children older than 3 to 5 years
  • StratMedPaediatrics: Stratified Medicine Paediatrics: Genomic Characterisation  of Relapsed Paediatric Cancers for Diagnostics and Stratified Therapy
  • UKALL2011: United Kingdom national randomised trial for children and young adults with Acute Lymphoblastic Leukaemia and Lymphoma 2011
  • Veritas: An international multicenter phase II randomised trial evaluating and comparing two intensification treatment strategies for metastatic neuroblastoma patients with a poor response to induction chemotherapy. A SIOPEN Study
  • Vinilo: Phase I-II study of Vinblastine in combination with Nilotinib in children, adolescents, and young adults with refractory or recurrent Low-Grade Glioma
  • VIT0910: International Randomised Phase II Trial of the Combination of Vincristine and Irinotecan with or without Temozolomide (VI or VIT) in Patients with Refractory or Relapsed Rhabdomyosarcoma

Urological cancer

  • ADIUVO: Efficacy of adjuvant mitotane treatment in prolonging recurrence-free survival in patients with adrenocortical carcinoma at low-intermediate risk of recurrence
  • AdUP: A phase 1 clinical trial of a replication defective adenovirus (type 5) vector expressing nitroreductase and GMCSF (AdNRGM) given via brachytherapy, followed by CB1954, in patients with locally relapsed hormone-refractory prostate cancer
  • ADVICE: A feasibility study of molecular markers in patients with muscle invasive transitional cell carcinoma of the bladder entered into neo-adjuvant chemotherapy trial
  • AMRCC: A study of angiogenesis markers in patients with Renal Cell Carcinoma therapy with sunitinib: correlations with tumour response and prognosis
  • BC2001: A randomised phase III study of radiotherapy with or without synchronous chemotherapy in muscle invasive bladder cancer
  • BCPP/SELENIB: Bladder cancer prognosis programme and phase III trial of vitamin E and selenium
  • BladderPath: Image Directed Redesign of BladderCancer Treatment Pathways
  • CANTATA: A multicentre phase II randomised controlled trial evaluating docetaxel re-challenge versus cabazitaxel for the treatment of metastatic castrate refractory prostate cancer, previously treated with docetaxel at inception of primary hormone therapy
  • HYMN: A randomised controlled Phase III trial comparing hyperthermia plus mitomycin to a second course of bacillus Calmette-Guérin or standard therapy in patients with recurrence of non-muscle invasive bladder cancer following induction or maintenance bacillus Calmette-Guérin therapy
  • PAZ02: A study of pazopanib efficacy and safety in patients with advanced clear-cell renal cell carcinoma and Performance Status 2 (ECOG)
  • Relapsed Wilms: Protocol for the treatment of relapsed and refractory Wilms tumour and clear cell sarcoma of the Kidney (CCSK) UKW-R  (WT 2001 02)
  • SIOP WILMS: SIOP nephroblastoma (wilms tumour) clinical trial and study
  • Trapeze: A randomised phase II/III  study of docetaxel plus prednisolone vs docetaxel plus prednisolone plus zoledronic acid vs docetaxel plus prednisolone plus strontium-89 vs docetaxel plus prednisolone plus zoledronic acid plus strontium-89 in hormone refractory prostate  cancer metastatic to bone
  • TUBA: A study of biomarkers in muscle invasive bladder cancer
  • TUXEDO: Phase I/II feasibility study of cetuximab with  5-FU and mitomycin c or cisplatin with concurrent radiotherapy in muscle invasive bladder cancer
  • WT3: WT-3 (WT 1991 01): Trial of preoperative chemotherapy in biopsy proven Wilms' tumour versus immediate nephrectomy

Sarcoma

  • Axi-STS: A clinicopathological phase II study of axitinib in patients with advanced angiosarcoma and other soft tissue sarcomas
  • EE99: EUROpean Ewing tumour working initiative of national groups - Ewing tumour studies 1999Patie
  • MMT 98 PK: MMT 98 PK (PK 2000 05)
  • rEECur: An International Randomised Controlled Trial of Chemotherapy for the treatment of reccurent and primary refractory Ewing sarcoma
  • SCART: Phase I/II study of oral MEK inhibitor Selumetinib (AZD6244 Hyd-Sulphate) in Combination with Highly Active Anti-Retroviral Therapy (HAART) in AIDS-associated Kaposi’s sarcoma (KS)
  • SIOP MMT 95: SIOP MMT 95 (STS 1995 07): For Rhabdomyosarcoma and other malignant soft tissue tumours of childhood
  • Vortex: Randomised trial of dose and volume of post-operative radiotherapy given to adult patients with extremity soft tissue sarcoma