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 |
| Secondary identifying numbers | UCL 09/0060 |
- 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
Contact information
Dr Beatrice Seddon
Scientific
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 |
|---|---|
| beatrice.seddon@uclh.nhs.uk |
Study information
| Study design | Randomised controlled phase III multi-national trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Gemcitabine, docetaxel, doxorubicin |
| Primary outcome measure | 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 study start date | 01/01/2010 |
| Completion date | 01/01/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Sex | Both |
| Target number of participants | 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
- Australia
- England
- Ireland
- United Kingdom
Study participating centre
UCL Hospital NHS Trust
London
NW1 2PG
United Kingdom
NW1 2PG
United Kingdom
Sponsor information
University College London (UCL) (UK)
University/education
University/education
Joint UCLH and UCL Biomedical Research Unit
1st Floor Maple House
Ground Floor, Rosenheim Wing
25 Grafton Way
London
WC1E 5DB
England
United Kingdom
| Website | http://www.ucl.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/02jx3x895 |
Funders
Funder type
Charity
Cancer Research UK (CRUK) (UK)
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- CR_UK, Cancer Research UK - London, CRUK
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| 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 | |
| Plain English results | 24/01/2022 | No | Yes | ||
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
24/01/2022: A link to plain English results was added.
19/10/2017: Publication reference added.
