Cancer Research Clinical Trials Unit (CRCTU)

 The Cancer Research UK Clinical Trials Unit (CRCTU) is a specialist research unit with the remit to design, conduct, analyse and publish investigator-led and initiated clinical trials. It is one of two clinical trials units within University of Birmingham and is one of the largest United Kingdom Clinical Research Collaboration (UKCRC) registered clinical trials units.

CRUK-Logo-2013

The Unit aims to translate cutting edge science into improved patient care, both rapidly and safely, through the design and conduct of large multi-centre, international randomised trials as well as smaller phase I trials of novel therapies.

 

Find out more at the Cancer Research Clinical Trials Unit website

Why work with us

The CRCTU specialises in cancer trials but also has a portfolio of early phase non-cancer trials (delivered via the D3B team based in the Institute of Translational Medicine). The Unit runs trials for both adults and children, being the National Children’s Cancer Trials Unit. The CRCTU also hosts several national cancer programmes including: the Trial Acceleration Program (TAP) funded by Bloodwise; the IMPACT programme funded by Anthony Nolan, Leuka and NHS Blood and Transplant; and is the clinical trials unit for the Birmingham Experimental Cancer Centre (ECMC). The Unit also plays a key role in the delivery of trials for the Birmingham NIHR Biomedical Research Centre (BRC), Midlands & Wales Advanced Therapy Treatment Centre (MW-ATTC), and Arthritis Trials Acceleration Programme (A-TAP).

CRCTU works in partnership with the Birmingham Clinical Trials Unit (BCTU) to deliver the Birmingham Surgical Trials Consortium (BiSTC).

The CRCTU has over 40 years experience of collaborating with clinicians in designing efficient and innovative clinical trials, supporting successful funding applications and delivering regulatory compliant academic investigator-initiated and led clinical trials to a high standard of Good Clinical Practice (GCP). The Unit undertakes all tasks required to deliver a clinical trial from conception to completion (see Resources and Services).

The Unit has experience of running trials of:

  • Investigational medicinal products (CTIMPS)
  • Advanced therapy medicinal products (ATIMPs)
  • Immunotherapy
  • Radiotherapy
  • Surgery
  • Devices

The CRCTU is able to harness what is a key asset of Birmingham its single Biomedical Campus which encompasses: the CRUK Birmingham Cancer Centre; the Birmingham Experimental Cancer Medicine Centre; the Birmingham Health Partners Institute of Translational Medicine; the Human Biomaterials Research Centre; the West Midlands Regional Genetics Laboratory; the adult and paediatric NIHR Welcome Trust Clinical Research Facilities; University Hospitals NHS Foundation Trust; and Birmingham Women and Children’s Hospital.

Who do we work with

The CRCTU works with clinical researchers from a large number of academic institutions and hospitals around the world. Key facts and figures include:

  • 65% of our Chief Investigators are external to Birmingham.
  • We deliver international trials in collaboration with 21 countries.
  • We work with 347 sites around the world.
  • In the last 5-years we have worked collaboratively with more than 12 different industry partners ranging from big pharma to small biotech companies.

Resources and services

The CRCTU is an academic department which works in collaboration with investigators to undertake all tasks involved in the design, conduct and publication of a clinical trial in compliance with GCP, including:

  • Trial design
  • Systematic review
  • Protocol writing
  • Grant submissions
  • Ethics and regulatory submissions
  • Case report form design
  • Database development and maintenance
  • Site selection and set-up
  • Quality assurance and monitoring
  • Oversight committee management and reporting
  • Statistical analysis and methodological expertise
  • Publication and reporting
  • Site closure and archiving

Current research

Analysing The Results

 

 

 

The CRCTU key strategic research areas include:

Cancer disease sites

  • Breast cancer
  • Childhood and teenage and young adult cancers (including sarcomas)
  • Colorectal cancer
  • Haematological cancer
  • Hepatobiliary cancer
  • Lung cancer
  • Urological cancer

Non-cancer diseases

  • Inflammatory conditions
  • Liver disease
  • Rare diseases
  • Trauma

Cross cutting themes

  • Implementation of efficient trial designs
  • Biomarker-driven treatment stratification
  • Integration of biological studies and sample collections
  • Integrating Surgical Questions (cancer only)
  • Industry collaborations

Recent publications

BREAST CANCERS

  1. Earl, H.M., Vallier, A., Hiller, L., Fenwick, N., Young, J., Iddawela, M., Abraham, J., Hughes-Davies, L., Gounaris, I., McAdam K., Houston S., Hickish T., Skene A., Chan S., Dean S., Ritchie D., Laing R., Harries M., Gallagher C., Wishart G., Dunn J., Provenzano E., Caldas C.; Neo-tAnGo Investigators. 2014. Effects of the addition of gemcitabine, and paclitaxel-first sequencing, in neoadjuvant sequential epirubicin, cyclophosphamide, and paclitaxel for women with high-risk early breast cancer (Neo-tAnGo): an open-label, 2×2 factorial randomised phase 3 trial. The Lancet Oncology 15:201-12. (TRIAL RESULT)
  2. Bartlett, J.M., Christiansen, J., Gustavson, M., Rimm, D., Piper, T., de Velde, C.J., Hasenburg, A., Kieback, D., Putter, H., Markopoulos C.J., Dirix L.Y., Seynaeve C., Rea D.W., 2015. Validation of the IHC4 Breast Cancer Prognostic Algorithm Using Multiple Approaches on the Multinational TEAM Clinical Trial. Arch Pathol Lab Med 140:66-74. (TRIAL ASSOCIATED TRANSLATION RESEARCH)
  3. Bartlett, J.M.S., McConkey, C.C., Munro, A.F., Desmedt, C., Dunn, J.A., Larsimont, D.P., O'Malley, F.P., Cameron, D.A., Earl, H.M., Poole C.J., Shepherd L.E., Cardoso F., Jensen M.B., Caldas C., Twelves C.J., Rea D.W., Ejlertsen B., Di Leo A., Pritchard K.I., 2015. Predicting Anthracycline Benefit: TOP2A and CEP17—Not Only but Also. Journal of Clinical Oncology 33:1680-87 (TRIAL ASSOCIATED TRANSLATION RESEARCH)
  4. Stephen, J., Murray, G., Cameron, D.A., Thomas, J., Kunkler, I.H., Jack, W., Kerr, G.R., Piper, T., Brookes, C.L., Rea D.W., van de Velde C.J.H., Hasenburg A., Markopoulos C., Dirix L., Seynaeve C., Bartlett J.MS., 2014. Time dependence of biomarkers: non-proportional effects of immunohistochemical panels predicting relapse risk in early breast cancer. Br J Cancer 111:2242-7. (TRIAL ASSOCIATED TRANSLATION RESEARCH)
  5. Abraham, J.E., Hiller, L., Dorling, L., Vallier, A.L., Dunn, J., Bowden, S., Ingle, S., Jones, L., Hardy, R., et al., 2015. A nested cohort study of 6,248 early breast cancer patients treated in neoadjuvant and adjuvant chemotherapy trials investigating the prognostic value of chemotherapy-related toxicities. BMC medicine 13:306. (TRIAL ASSOCIATED TRANSLATION RESEARCH)

UROLOGICAL CANCERS

  1. Andronis, L., Goranitis, I., Pirrie, S., Pope, A., Barton, D., Collins, S., Daunton, A., McLaren, D., O'Sullivan, J., Parker C., Porfiri E., Staffurth J., Stanley A., Wylie J., Beesley S., Birtle A., Brown J.E., Chakraborti P., Hussain S.A., Russell J.M., Billingham L., James N.D., 2016. Cost-effectiveness of zoledronic acid and strontium-89 as bone protecting treatments in addition to chemotherapy in patients with metastatic castrate-refractory prostate cancer: results from the TRAPEZE trial (ISRCTN 12808747). BJU International. (TRIAL RESULT)
  2. James, N.D., Pirrie, S.J., Pope, A.M., Barton, D., Andronis, L., Goranitis, I., Collins, S., Daunton, A., McLaren, D.,  O'Sullivan J., Parker C., Porfiri E., Staffurth J., Stanley A., Wylie J., Beesley S., Birtle A., Brown J., Chakraborti P., Hussain S., Russell M., Billingham L., 2016. Clinical outcomes and survival following treatment of metastatic castrate-refractory prostate cancer with docetaxel alone or with strontium-89, zoledronic acid, or both: the TRAPEZE randomised clinical trial. JAMA Oncology 2:493-99 (TRIAL RESULT)

LUNG CANCER

  1. Ferry D, Billingham L, Jarrett H, Dunlop D, Woll PJ, Nicolson M, Shah R, Thompson J, Spicer J, Kumar M, Skailes G, Leonard P, Chetiyawardana AD, Wells P, Lewanski C, Crosse B, Hill M, Gaunt P, O’Byrne K; 2017 Carboplatin versus two doses of cisplatin in combination with gemcitabine in the treatment of advanced non-small-cell lung cancer: results from a British Thoracic Oncology Group randomised phase III trial. European Journal of Cancer (in press) (TRIAL RESULT)

PRECISION MEDICINE/EARLY PHASE TRIALS IN ADULT CANCERS

  1. Middleton, G., Crack, L.R., Popat, S., Swanton, C., Hollingsworth, S.J., Buller, R., Walker, I., Carr, T.H., Wherton, D., et al., 2015. The National Lung Matrix Trial: translating the biology of stratification in advanced non-small-cell lung cancer. Ann Oncol 26:2464-9 (TRIAL METHODOLOGY)
  2. Taylor, G.S., Jia, H., Harrington, K., Lee, L.W., Turner, J., Ladell, K., Price, D.A., Tanday, M., Matthews, J., Billingham L.J., 2014. A Recombinant Modified Vaccinia Ankara Vaccine Encoding Epstein-Barr Virus (EBV) Target Antigens: A Phase I Trial in UK Patients with EBV-Positive Cancer. Clin Cancer Res 20:5009-22. (TRIAL RESULT)

ADULT HAEMATOLOGICAL CANCERS

  1. Craddock, C., Jilani, N., Siddique, S., Yap, C., Khan, J., Nagra, S., Ward, J., Ferguson, P., Hazlewood, P.,  Buka R., Vyas P., Goodyear O., Tholouli E., Crawley C., Russell N., Byrne J., Malladi R., Snowden J., Dennis M., 2016. Tolerability and clinical activity of post-transplantation azacitidine in patients allografted for Acute Myeloid Leukemia treated on the RICAZA trial. Biol Blood Marrow Transplant 22:385-90. (TRIAL RESULT)
  2. Craddock C., Houlton A.E., Quek L.S., Ferguson P., Gbandi E., Roberts C.,, Metzner M., Garcia-MartinN., Kennedy A., Hamblin A., Raghavan M., Nagra S., Dudley L., Wheatley K.,  McMullin M.F., Pillai S.P., Kelly R.J., Siddique S., Dennis M., Cavenagh J.D., Vyas P., 2017 Outcome of Azacitidine Therapy in Acute Myeloid Leukemia is not Improved by Concurrent Vorinostat Therapy but is Predicted by a Diagnostic Molecular Signature   Clinical Cancer Research in press (TRIAL RESULT)
  3. Harrison C.N., Mead A.J., Panchal A., Fox S., Yap C., Gbandi E., Houlton A.E., Alimam S., Ewing J., Wood M., Chen F., Coppell J., Panoskaltsis N., Knapper S., Ali S., Hamblin A., Scherber R., Dueck A., Cross N.C.P., Mesa R., McMullin M.F., Ruxolitinib versus Best Available Therapy for ET intolerant or resistant to Hydroxycarbamide in a Randomized trial 2017 Blood in press (TRIAL RESULT)
  4. Yap C, Billingham L, Cheung K, Craddock C, O’Quigley J.  “Dose Transition Pathways: The missing link between complex dose-finding designs and simple decision-making”.  Clinical Cancer Research (2017) (TRIAL METHODOLOGY)
  5. Brock K., Billingham L., Copland M., Siddique S., Sirvica M., Yap C., 2017. Implementing the EffTox dose-finding design in the Matchpoint trial BMC Medical Research Methodology (2017) 17:112-127 (TRIAL METHODOLOGY)

CHILDHOOD AND ADOLESCENT CANCERS

  1. Taylor, R.E., Howman, A.J., Wheatley, K., Brogden, E.E., Large, B., Gibson, M.J., Robson, K., Mitra, D., Saran, F., Michalski A., Pizer BL., 2014. Hyperfractionated Accelerated Radiotherapy (HART) with maintenance chemotherapy for metastatic (M1-3) Medulloblastoma - A safety/feasibility study. Radiother Oncol 111:416. (TRIAL RESULT)
  2. Pritchard-Jones, K., Bergeron, C., B., d.C., van den Heuvel-Eibrink, M.M., Acha, T., Godzinski, J., Oldenburger, F., Boccon-Gibod, L., Leuschner, I.,  Vujanic G10, Sandstedt B11, de Kraker J12, van Tinteren H13, Graf N14; SIOP Renal Tumours Study Group., 2015. Omission of doxorubicin from the treatment of stage II-III, intermediate-risk Wilms' tumour (SIOP WT 2001): an open-label, non-inferiority, randomised controlled trial. Lancet 386:1156-64. (TRIAL RESULT)
  3. Le Deley, M.C., Paulussen, M., Lewis, I., Brennan, B., Ranft, A., Whelan, J., Le Teuff, G., Michon, J., Ladenstein, R., Marec-Bérard P., van den Berg H., Hjorth L., Wheatley K., Judson I., Juergens H., Craft A, Oberlin O, Dirksen U. 2014. Cyclophosphamide compared to ifosfamide in consolidation treatment of standard-risk Ewing sarcoma: results of the randomised non-inferiority Euro-E.W.I.N.G.99 R1 trial. J Clin Oncol 32:2440-8. (TRIAL RESULT)
  4. Moroz, V., Wilson, J.S., Kearns, P., Wheatley, K., 2014. Comparison of anticipated and actual control group outcome in randomised trials in paediatric oncology provides evidence that historically controlled studies are biased in favour of the novel treatment. Trials MS 15:481. (TRIAL METHODOLOGY)
  5. Wilson, J.S., Gains, J.E., Moroz, V., Wheatley, K., Gaze, M.N., 2014. A systematic review of (131)I-meta iodobenzylguanidine molecular radiotherapy for neuroblastoma. Eur J Cancer 50:801-15. (SYSTEMATIC REVIEW)

Contact us

Those wishing to collaborate with the CRCTU are asked to contact the CRCTU Clinical Trials Facilitator via email in the first instance:

Email: newbusiness@trials.bham.ac.uk

Telephone: +44 (0)121 414 9247