Cetuximab with chemoradiotherapy in bladder cancer (TUXEDO)

• Research type

  Research Study

• Full title

  Phase I/II feasibility study of cetuximab with 5FU and Mitomycin C or cisplatin with concurrent radiotherapy in muscle invasive bladder cancer (TUXEDO)

• IRAS ID

  30210

• Contact name

  Nicholas James

• Contact email

  N.D.James@bham.ac.uk

• Sponsor organisation

  University of Birmingham

• Eudract number

  2009-014805-15

• ISRCTN Number

  ISRCTN80733590

• Clinicaltrials.gov Identifier

  BL2101, CRCTU reference number; EMR 62202-849, Merck Serono study number

• Duration of Study in the UK

  5 years, 9 months, 30 days

• Research summary

  Combining radiotherapy with drug therapy has produced impressive outcome gains in a number of cancers, including bladder cancer. We aim to combine radiotherapy (a current standard treatment) with a new drug, cetuximab, as well as standard chemotherapy drugs, either fluorouracil with mitomycin C or cisplatin. We will initially evaluate the safety of the combinations. Subject to satisfactory safety data we will go on to study the preliminary efficacy of the combination therapy as a basis for future trials.

• REC name

  London - Bloomsbury Research Ethics Committee

• REC reference

  11/LO/1313

• Date of REC Opinion

  21 Sep 2011

• REC opinion

  Favourable Opinion