A Randomized, Multicenter, Phase III Trial of Trabectedin (Yondelis®) versus Doxorubicin-based Chemotherapy as First-Line Therapy in Patients with Translocation-Related Sarcomas (TRS)
- Conditions
- Translocation-Related SarcomasMedDRA version: 9.1 Level: HLGT Classification code 10041299 Term: Soft tissue sarcomas
- Registration Number
- EUCTR2008-002326-11-GB
- Lead Sponsor
- Pharma Mar, S.A., Sociedad Unipersonal
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 121
1) Patient’s written informed consent before any study-specific procedures.
2) Adult patients (age = 18 years).
3) Patients with pathological diagnosis of TRS (institutional assessment) of any, but restricted to the following subtypes: alveolar soft part sarcoma, angiomatoid fibrous histiocytoma, clear cell sarcoma, desmoplastic small round cell tumor, low grade endometrial stromal sarcoma (prior hormone therapy allowed), low grade fibromyxoid sarcoma, myxoid chondrosarcoma, MRCL and synovial sarcoma. Availability of adequate tumor material for external review is mandatory.
4) Patients must have unresectable locally advanced or metastatic progressive disease prior to enrolment.
5) Measurable disease as defined by the radiological (CT-scan and MRI) Response Evaluation Criteria in Solid Tumors (RECIST) Guidelines.
6) ECOG PS score of 0-2.
7) Adequate cardiac function, defined as LVEF within normal limits according to institutional standards, as shown by echocardiography or scintigraphy (MUGA).
8) Hematological variables:
a) Hemoglobin = 9 g/dl.
b) ANC = 1,500/µl.
c) Platelet count = 100,000/µl.
9) Biochemical variables:
a) Serum creatinine = 1.5 mg/dl
b) CPK = 2.5 x ULN.
10) Hepatic function variables:
a) Total bilirubin = ULN, unless in case of Gilbert's syndrome
b) Total AP = 2.5 x ULN, or if > 2.5 x ULN consider AP liver fraction, and/or GGT, and/or 5’ nucleotidase must be = ULN
c) AST/SGOT and ALT/SGPT must be = 2.5 x ULN
d) Albumin = 25 g/l.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1) Known hypersensitivity to any of the components of the i.v. formulation of trabectedin or the comparators.
2) Prior chemotherapy treatment.
3) Prior irradiation of the lesion if only one target lesion (i.e., measurable) is available.
4) Pregnant or lactating women or men and women of reproductive potential who are not using effective contraceptive methods (one or more of the following):
a) Complete abstinence from intercourse from two weeks prior to administration of the study treatment, throughout the study, and for at least six months after completion or premature discontinuation from the study to account for elimination of the investigational drug(s); or,
b) Physical sterilization of the patient or the patient’s partner; or, c) One of the following, for female patients or female partners of male patients: - Implants of levonorgestrel; or, - Injectable progestogen; or, - Oral contraceptive (combined or progestogen only; patients taking oral contraceptives should have been on a stable regimen for at least two months prior to screening), or, - Any IUD with published data showing that the lowest expected failure rate is less than 1% per year (not all IUDs meet this criterion); or, - Double barrier method (two physical barriers or one physical barrier plus spermicide); or, - Any other methods with published data showing that the lowest expected failure rate for that method is less than 1% per year.
5) History of another neoplastic disease (except basal cell carcinoma or cervical carcinoma in situ adequately treated) unless in remission for five years or more.
6) Brain metastases and/or leptomeningeal metastases, even if treated.
7) Other serious illnesses, such as:
a) Congestive heart failure or angina pectoris; myocardial infarction within one year before enrolment; uncontrolled arterial hypertension (according to WHO criteria), arrhythmias or abnormal LVEF.
8) Psychiatric disorder or any other personal circumstances that prevent compliance with the study protocol.
9) Active viral hepatitis or chronic liver disease.
10) Active infection.
11) Any other unstable medical condition.
12) Inability or unwillingness to comply with the study protocol.
13) Prior treatment with any investigational drugs/treatments within 30 days before inclusion into the current study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method