ISRCTN07742377
Completed
Phase 3
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
niversity College London (UCL) (UK)0 sites250 target enrollmentSeptember 11, 2009
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- niversity College London (UCL) (UK)
- Enrollment
- 250
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
2017 Results article in https://www.ncbi.nlm.nih.gov/pubmed/28882536 results
Investigators
Eligibility Criteria
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
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
Outcomes
Primary Outcomes
Not specified
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