Gemcitabine and Docetaxel versus Doxorubicin as first line treatment in previously untreated advanced unresectable or metastatic soft tissue Sarcomas

ISRCTN	ISRCTN07742377
DOI	https://doi.org/10.1186/ISRCTN07742377
Protocol serial number	UCL 09/0060
Sponsor	University College London (UCL) (UK)
Funder	Cancer Research UK (CRUK) (UK)

Submission date: 29/07/2009
Registration date: 11/09/2009
Last edited: 24/01/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

http://www.cancerhelp.org.uk/trials/a-trial-comparing-gemcitabine-docetaxel-with-doxorubicin-soft-tissue-sarcomas-geddis

Contact information

Dr Beatrice Seddon
Scientific

The London Sarcoma Service
Department of Oncology
UCL Hospital NHS Trust
1st Floor Central
250 Euston Road
London
NW1 2PG
United Kingdom

Phone	+44 (0)20 7380 9866
Email	beatrice.seddon@uclh.nhs.uk

Study information

Primary study design	Interventional
Study design	Randomised controlled phase III multi-national trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Study acronym	GeDDiS
Study objectives	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(s)	Central London REC 2, Royal Free Hospital, London, 11/08/2010, ref: 10/H0713/54
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Gemcitabine, docetaxel, doxorubicin
Primary outcome measure(s)	Progression-free survival, assessed using the RECIST Criteria every six weeks (after each set of two cycles); following treatment assessment will be 2-monthly.
Key secondary outcome measure(s)	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.
Completion date	01/01/2013

Eligibility

Participant type(s)	Patient
Age group	Mixed
Sex	All
Target sample size at registration	250
Key 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%
Key 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
Date of first enrolment	01/01/2010
Date of final enrolment	01/01/2013

Locations

Countries of recruitment

United Kingdom
England
Australia
Ireland

Study participating centre

UCL Hospital NHS Trust

London
NW1 2PG
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/10/2017		Yes	No
HRA research summary			28/06/2023	No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Plain English results			24/01/2022	No	Yes

Editorial Notes

24/01/2022: A link to plain English results was added.
19/10/2017: Publication reference added.