GeDDiS

• Research type

  Research Study

• Full title

  A prospective randomised controlled phase III trial of gemcitabine and docetaxel compared with doxorubicin as first line treatment in previously untreated advanced unresectable or metastatic soft tissue sarcomas

• IRAS ID

  30246

• Contact name

  Beatrice Seddon

• Sponsor organisation

  University College London

• Eudract number

  2009-014907-29

• ISRCTN Number

  ISRCTN07742377

• Research summary

  Sarcomas are rare tumours and account for approximately 1% of all cancer diagnoses. The annual incidence rate was 2,025 cases in the UK in 2006, including bone and soft tissue sarcomas. Currently the standard treatment for soft tissue sarcoma which has spread to other areas of the body or come back after initial treatment with surgery and radiotherapy is chemotherapy using doxorubicin. This study is going to compare whether a new chemotherapy combination, gemcitabine and docetaxel will help patients to have a longer period of time after treatment before their cancer grows again, to improve their quality of life and to have less side effects than when they are treated with doxorubicin. 250 patients will be recruited in this study, in the UK, Australia and New Zealand. Patients will either receive 6 cycles of gemcitabine and docetaxel or 6 cycles of doxorubicin. This study is funded by Cancer research UK.

• REC name

  London - Bloomsbury Research Ethics Committee

• REC reference

  10/H0713/54

• Date of REC Opinion

  11 Aug 2010

• REC opinion

  Favourable Opinion