EORTC 1209-EnTF

• Research type

  Research Study

• Full title

  A phase II study exploring the safety and efficacy of nintedanib (BIBF1120) as second line therapy for patients with either differentiated or medullary thyroid cancer progressing after first line therapy.

• IRAS ID

  138557

• Contact name

  Kate Newbold

• Contact email

  kate.newbold@rmh.nhs.uk

• Sponsor organisation

  EORTC

• Eudract number

  2012-004295-19

• Clinicaltrials.gov Identifier

  NCT01788982

• Duration of Study in the UK

  3 years, 5 months, 1 days

• Research summary

  Thyroid cancer is the most common endocrine cancer. Of these, differentiated carcinomas (DTC; papillary and follicular) are by the most common type, while medullary thyroid cancer (MTC) accounts for 5-10% of cases. The first treatment for these cancers in the early stage is usually removal of the thyroid (thyroidectomy). For patients at risk of recurrence, this surgery is followed up with radiotherapy. Patients who do experience metastases or a recurrence are treated with chemotherapy.
  This aim of this study is to trial Nintedanib in patients with disease progression following these interventions. No clinical benefits have been proven with other chemotherapy agents but patients are still in relatively good general health. Nintedanib acts on the growth of blood vessels into the tumour by blocking three different pathways that promote blood vessel growth, which is a different way of targeting the disease to the other less successful methods, and potentially works equally well with both TDC and MTC.

  This trial also includes translational research on the tumour tissue taken from the patients during surgery. A central pathology review will retrospectively examine tumour cells to identify cases in which the central laboratory disagrees with the local laboratory’s findings. The aim is to generate information for local pathologists: MTC diagnosis may be challenging and therefore diagnosis needs to be confirmed centrally in order to avoid any discordance.

  The tissue will also be examined for particular biomarkers observed in thyroid carcinomas. These markers will be tested for their prognostic and predictive value with respect to progression-free survival and overall survival and OS).

• REC name

  London - Chelsea Research Ethics Committee

• REC reference

  15/LO/0171

• Date of REC Opinion

  28 Apr 2015

• REC opinion

  Further Information Favourable Opinion