Condition category
Cancer
Date applied
29/07/2009
Date assigned
11/09/2009
Last edited
18/06/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

http://www.ucl.ac.uk/

Funders

Funder type

Charity

Funder name

Cancer Research UK (CRUK) (UK)

Alternative name(s)

CRUK

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

Publication citations

Additional files

Editorial Notes