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

Phase 3

Completed

• Conditions: Soft tissue sarcomas; Cancer; Malignant neoplasm of other connective and soft tissue

• Registration Number: ISRCTN07742377
• Lead Sponsor: niversity College London (UCL) (UK)

Brief Summary

2017 Results article in https://www.ncbi.nlm.nih.gov/pubmed/28882536 results

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-09-11
• Study Completion: 2013-01-01
• Last Update Posted: 7 February 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 250

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%

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
<br> 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<br> 2. Toxicity, continuously assessed and recorded using the NCI Common Terminology Criteria for Adverse Events v4.0<br> 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.<br>