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 - GeDDiS
- Conditions
- ocally advanced unresectable or metastatic soft tissue sarcoma.MedDRA version: 14.1Level: HLGTClassification code 10041299Term: Soft tissue sarcomasSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
- Registration Number
- EUCTR2009-014907-29-GB
- Lead Sponsor
- niversity College London
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 257
•Locally advanced or metastatic soft tissue sarcoma, incurable by surgery or radiotherapy •Histological confirmation of high grade disease (Trojani grade 2 or 3 sarcoma) •Prior to trial enrolment, patients must have evidence of disease progression. Disease progression is defined as radiological progression when comparing current imaging to a prior disease assessment carried out within the previous 6 months. Some patients may present with evidence of clinical progression for whom there is concern regarding treatment delays incurred by awaiting radiological disease progression prior to trial entry – these cases must be discussed with the Chief Investigator to determine eligibility •No prior chemotherapy regimen for sarcoma and no prior doxorubicin containing regimen for any previously treated cancer •WHO performance status 0 – 2 •Age =13 years •Histological material available for central review (see section 8.7) •Measurable disease evaluable by RECIST criteria version 1.1. New lesions occurring in previously irradiated fields, and progression of previously irradiated lesions, will be eligible •Life expectancy of at least 3 months •Adequate organ function: Neutrophils =1.0 x 10*9/L Platelets =100 x 10*9/L Bilirubin =1.5 x upper limit of normal (ULN) AST or ALT =3.0 x ULN ALP =3.0 x ULN, if ALP = 3.0 x ULN, patients can be entered if this is shown to be bone isoenzyme Measured or calculated creatinine clearance =30 ml/min Ejection fraction (measured according to local practice) within normal limits for the site •Patients to agree to use contraception for the duration of the trial, where applicable (see section 5.3.3) •Able to complete quality of life questionnaires •Able to give informed consent
Are the trial subjects under 18? yes
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 0
•Soft tissue sarcoma of the following types: Alveolar soft part sarcoma Gastrointestinal stromal tumour Ewing’s sarcoma family of tumours Alveolar or embryonal rhabdomyosarcoma Desmoplastic small round cell tumour Extra-skeletal myxoid chondrosarcoma Dermatofibrosarcoma protruberans Malignant mixed mesodermal tumour/carcinosarcoma of the uterus Smooth muscle tumours of uncertain malignant potential (STUMP) •Known active/uncontrolled brain metastases •Grade 3 or 4 peripheral neuropathy •Active uncontrolled infection •Prior history of malignancy other than sarcoma, except for basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, breast or prostate, and unless the patient has been free of malignancy for a period of 3 years prior to first dose of trial drug •Women who are pregnant or lactating •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 clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The principal research objective is to compare the efficacy and effectiveness of gemcitabine and docetaxel with that of doxorubicin.;Secondary Objective: -To compare the efficacy and effectiveness of gemcitabine and docetaxel with doxorubicin using additional endpoints. -To compare the toxicity observed with the two treatment regimens -To compare the quality of life of patients treated with gemcitabine and docetaxel with those treated with doxorubicin -To compare the cost-effectiveness of the two treatment regimens -To investigate the influence of pharmacogenomic profiles of patients on disease response and treatment toxicity of the two treatment regimens (whether patients have specific genes that may cause them to process drugs such that they experience more or less toxicity).;Primary end point(s): Proportion of patients alive and progression free at 24 weeks after the date of randomisation
- Secondary Outcome Measures
Name Time Method