Gemcitabine and Docetaxel versus Doxorubicin as first line treatment in previously untreated advanced unresectable or metastatic 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. CONDITION: Soft tissue sarcomas ; Cancer ; Malignant neoplasm of other connective and soft tissue PRIMARY OUTCOME: 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: 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. 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