Phase II randomized study for the comparison of trabectedin versus doxorubicin plus
dacarbazine in patients with advanced solitary fibrous tumor
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Full eligibility criteria for NCT03023124
Ages eligible for Study
18 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
The patient or legal representative must be able to read and understand the informed consent form (ICF) and must have been willing to give written informed consent and any locally required authorisation before any study-specific procedures, including screening evaluations, sampling, and analyses.
Age ≥18 years
Histological centrally and molecularly confirmed diagnosis of solitary fibrous tumor
(inclusive of the last available tumor sample)
Locally advanced disease (i.e. surgical resection of local disease unfeasible radically, or unaccepted by the patient, or amenable to become less demolitive, or feasible, or easier, after cytoreduction) and/or metastatic disease
Measurable or evaluable disease with RECIST
Evidence of progression by RECIST during the 6 months before study entry
Patients must be cytotoxic chemotherapy naïve (patients treated with neoadjuvant/adjuvant chemotherapy cannot be included) or could have received a previous target agent in front-line setting.
Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2
Adequate bone marrow function
Adequate organ function
Cardiac ejection fraction ≥50% as measured by echocardiogram
Female patients of child-bearing potential must have negative pregnancy test within 7 days before initiation each cycle of chemotherapy. Post-menopausal women must be amenorrhoeic for at least 12 months to be considered of non-childbearing potential. Male and female patients of reproductive potential must agree to employ an effective method of birth control throughout the study.
No history of arterial and/or venous thromboembolic event within the previous 12 months.
Any prior treatment with cytotoxic chemotherapy
>1 line of anticancer targeted agents
Previous treatment with any other investigational or not investigational agents within 14 days of first day of study drug dosing
Previous treatment with radiation therapy within 14 days of first day of study drug dosing, or patients who have not recovered from adverse events due to agents previously administered
Previous radiotherapy to 25 % of the bone marrow
Major surgery within 4 weeks prior to study entry
Other primary malignancy with <5 years clinically assessed disease-free interval, except basal cell skin cancer, cervical carcinoma in situ, or other neoplasms judged to entail a low risk of relapse
Pregnancy or breast feeding
Cardiovascular diseases resulting in a New York Heart Association Functional Status >2
(24). Medical history of a myocardial infarction < 6 months prior to initiation of study treatment
Medical history of arterial thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), or pulmonary embolism within 6 months prior to the initiation of study treatment
Known history of human immunodeficiency virus infection
Active or chronic hepatitis B or C requiring treatment with antiviral therapy
Medical history of hemorrhage or a bleeding event ≥ Grade 3 (NCI‐CTCAE v 4.0) within 4 weeks prior to the initiation of study treatment
Evidence of any other serious or unstable illness, or medical, psychological, or social condition, that could jeopardize the safety of the subject and/or his/her compliance with study procedures, or may interfere with the subject's participation in the study or evaluation of the study results
Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation of the study drugs
Expected non-compliance to medical regimens
All locations for NCT03023124
Fondazione IRCCS Istituto Nazionale dei Tumori
Milano, MI, Italy, 20133
not yet recruiting
Policlinico Universitario Campus Biomedico
Roma, RM, Italy, 00128
not yet recruiting
Fondazione Del Piemonte Per L'Oncologia Ircc Di Candiolo -
Candiolo, Italy, 10060
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not yet recruiting
View full eligibility
Tris trial is registered with FDA with number: NCT03023124. The sponsor of the trial is Italian Sarcoma Group and it is looking for 50 volunteers for the current phase.
Official trial title: Solitary Fibrous Tumor: Phase II Study on Trabectedin Versus Adriamycin Plus Dacarbazine in Advanced Patients
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