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Trial Details
Trial status:
Closed
Recruitment start date:
25/11/2010
Funder:
Cancer Research UK
Sponsor:
UCL
Chief Investigator:
Dr Beatrice Seddon
Recruitment target:
250
EudraCT number:
2009-014907-29
Contact details:
ctc.geddis@ucl.ac.uk
Lay summary:
GeDDiS
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.
Description
Design: GeDDiS was a randomised, phase III multinational trial, with patients stratified according to age (≤18 or >18) and histological subtype (uterine leiomyosarcoma, synovial sarcoma, pleomorphic sarcoma, and other eligible sarcomas).
Treatment: Patients were randomised to receive either doxorubicin (75 mg/m2) day 1 every 3 weeks for up to 6 cycles, or gemcitabine (675 mg/m2) days 1 and 8 and docetaxel (75 mg/m2) day 8 every 3 weeks for up to 6 cycles.
Key inclusion/exclusion criteria: Patients with locally advanced or metastatic soft tissue sarcoma, with histologically confirmed high grade disease, measurable disease by RECIST v1.1, aged ≥13, evidence of disease progression prior to randomisation, no prior chemotherapy for sarcoma, no prior doxorubicin, WHO performance status 0-2, and a life expectancy of at least 3 months were eligible for the trial. 
Duration of recruitment: 257 patients were recruited from the UK and Switzerland between December 2010 and January 2014. Patients will be followed up until June 2019.
Aim
The overall aim was to determine whether gemcitabine and docetaxel was associated with an improved clinical outcome (progression free and overall survival) compared with single agent doxorubicin, as a first line treatment in patients with locally advanced or metastatic soft tissue sarcoma.
Trial protocols
Trial protocols must not be applied to patients treated outside trials. UCL CTC can only ensure that approved trial investigators are provided with amendments to protocols.
No protocols have been currently made available for download
Trial documents
No documents have been currently made available for download
Contact Us
Cancer Research UK & UCL Cancer Trials Centre
University College London
90 Tottenham Court Road
London
W1T 4TJ

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Email:
ctc.enquiries@ucl.ac.uk
Telephone:
+44 (0)20 7679 9898 (General CTC Enquiries)
Fax:
020 7679 9899
University College London, Gower Street, London, WC1E 6BT +44 (0)20 7679 2000

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