Plain English Summary
Trial website
Contact information
Type
Scientific
Primary contact
Dr Beatrice Seddon
ORCID ID
Contact details
The London Sarcoma Service
Department of Oncology
UCL Hospital NHS Trust
1st Floor Central
250 Euston Road
London
NW1 2PG
United Kingdom
+44 (0)20 7380 9866
beatrice.seddon@uclh.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
UCL 09/0060
Study information
Scientific 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
Acronym
GeDDiS
Study hypothesis
The proposed study aims to determine whether the combination of gemcitabine and docetaxel is associated with an improved clinical outcome compared with single agent doxorubicin.
Ethics approval
Central London REC 2, Royal Free Hospital, London, 11/08/2010, ref: 10/H0713/54
Study design
Randomised controlled phase III multi-national trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Soft tissue sarcomas
Intervention
Standard arm: doxorubicin 75 mg/m^2 day 1 every three weeks for up to 6 cycles.
Experimental arm: gemcitabine 675 mg/m^2 days 1 and 8, docetaxel 75 mg/m^2 day 8 every three weeks for up to 6 cycles with granulocyte-colony stimulating factor (GCSF) support days 8 - 15.
Both arms consist of six, three weekly cycles, a total of 18 weeks of treatment. Following treatment, patients will be followed up two monthly with clinical evaluation and scanning until disease progression, or death.
Intervention type
Drug
Phase
Phase III
Drug names
Gemcitabine, docetaxel, doxorubicin
Primary outcome measures
Progression-free survival, assessed using the RECIST Criteria every six weeks (after each set of two cycles); following treatment assessment will be 2-monthly.
Secondary outcome measures
1. Overall survival, time to progression and objective response rate assessed using the RECIST Criteria every six weeks (after each set of two cycles); following treatment assessment will be 2-monthly
2. Toxicity, continuously assessed and recorded using the NCI Common Terminology Criteria for Adverse Events v4.0
3. Quality of life, measured using the EORTC QLQ C30 for patients aged 16 years and greater and the PEDQOL questionnaire for patients aged less than 15 years. The EQ5D will also be used for health economic evaluation. Measured at baseline, prior to cycle 3 (6 weeks), prior to cycle 6 (15 weeks) and six weeks after the completion of treatment.
Overall trial start date
01/01/2010
Overall trial end date
01/01/2013
Reason abandoned
Eligibility
Participant inclusion criteria
1. Locally advanced or metastatic soft tissue sarcoma, incurable by surgery or radiotherapy
2. Evidence of disease progression in the 6 weeks prior to trial entry
3. No prior chemotherapy regimen for advanced or metastatic disease; (neo)adjuvant therapy is allowed
4. World Health Organization (WHO) performance status 0 - 2
5. Aged greater or equal to 13 years, either sex
6. Histologically confirmed soft tissue sarcoma excluding: alveolar soft part sarcoma, gastrointestinal stromal tumour, Ewing's sarcoma family of tumours, rhabdomyosarcoma
7. Desmoplastic small round cell tumour, extra-skeletal myxoid chondrosarcoma
8. Histological material available for central review
9. Measurable disease evaluable by Response Evaluation Criteria In Solid Tumours (RECIST) criteria
10. Life expectancy of at least 3 months
11. Adequate organ function:
11.1. Neutrophils greater than 1.5
11.2. Platelets greater than 100
11.3. Bilirubin less than or equal to 1.5 x upper limit of normal (ULN)
11.4. Aspartate aminotransferase (AST) less than or equal to 3 x ULN
11.5. Serum creatinine less than or equal to 1.5 x ULN; measured creatinine clearance greater or equal to 50 ml/min
12. Ejection fraction as assessed by multiple-gated acquisition scan (MUGA) or echocardiogram (ECHO) greater than or equal to 50%
Participant type
Patient
Age group
Mixed
Gender
Both
Target number of participants
250
Participant exclusion criteria
1. Known active central nervous system (CNS) metastases
2. Grade 3 or 4 peripheral neuropathy
3. Pregnancy or lactating
4. Active uncontrolled infection including known a history of acquired immune deficiency syndrome (AIDS)
5. Patients with previous non-sarcomatous malignancy should not have detectable disease and must not be on active treatment for the disease
6. Any serious and/or unstable pre-existing medical, psychiatric or other condition that could interfere with patient safety or obtaining informed consent
Recruitment start date
01/01/2010
Recruitment end date
01/01/2013
Locations
Countries of recruitment
Australia, Ireland, United Kingdom
Trial participating centre
UCL Hospital NHS Trust
London
NW1 2PG
United Kingdom
Sponsor information
Organisation
University College London (UCL) (UK)
Sponsor details
Joint UCLH and UCL Biomedical Research Unit
1st Floor Maple House
Ground Floor
Rosenheim Wing
25 Grafton Way
London
WC1E 5DB
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Cancer Research UK (CRUK) (UK)
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary