Efficacy Study on Trabectedin in Retroperitoneal Leiomyosarcoma and Well Differentiated/Dedifferentiated Liposarcoma (TRAVELL)
Liposarcoma, Leiomyosarcoma
About this trial
This is an interventional treatment trial for Liposarcoma focused on measuring STS, leiomyosarcoma, liposarcoma, trabectedin
Eligibility Criteria
Inclusion Criteria:
- Persistent or locally relapsed and/or metastatic disease (in case of local disease, surgery may be technically feasible or not, but the clinical judgment must be that medical therapy is indicated)
- Pathology specimens available for centralized review
- Age ≥ 18 years
- European Eastern Cooperative Oncology Group Personal Status (ECOG PS) ≤ 2
- One or more previous systemic treatments employing anthracyclines and ifosfamide (unless one or both are clinically contraindicated)
- Measurable disease, as defined by Response Evaluation Criteria In Solid Tumors (RECIST)
- A minimum of 3 weeks since any previous medical therapy
- Recovery from toxic effects of prior therapies to National Cancer Institute Common Toxicity Criteria (NCI CTC) Grade 1 or lower
- Adequate haematological, renal and liver functions
- Ability and willingness to provide informed consent
Exclusion Criteria:
- Pregnant or breast-feeding women
- Prior exposure to trabectedin
- Peripheral neuropathy, Grade 2 or higher
- History of other malignancies (except for basal cell carcinoma or cervical carcinoma in situ, adequately treated), unless in remission for 5 years or more and judged of negligible potential of relapse
- Known central nervous system (CNS) metastases
- Active viral hepatitis or chronic liver disease
- Unstable cardiac condition, including congestive heart failure or angina pectoris, myocardial infarction within one year before enrolment, uncontrolled arterial hypertension or arrhythmias
- Active major infection
- Other serious concomitant illnesses
Sites / Locations
- Istituto Tumori Giovanni Paolo II
- Azienda Ospedaliera Giovanni Paolo XXIII
- Azienda Ospedaliera S. Orsola-Malpighi
- A.O. Spedali Civili
- Ospedale Oncologico A. Businco
- Azienda Ospedaliera S Croce e Carle
- Azienda Ospedaliera Sant'Anna
- IRST IRCCS Meldola
- Fondazione IRCCS Istituto Nazionale dei Tumori
- Istituto Europeo di Oncologia
- Istituto Clinico Humanitas
- Azienda Ospedaliera Universitaria Paolo Giaccone
- Centro di Riferimento Oncologico di Aviano
- Istituto Oncologico Veneto
- Azienda Ospedaliera Universitaria Santa Chiara
- Ospedale Misericordia e Dolce
- Policlinico Universitario Campus Biomedico
- Istituto per la Ricerca e la Cura del Cancro di Candiolo
- Ospedale Gradenigo
- Azienda Ospedaliera Santa Maria
- Istituto Nazionale Tumori - IRCCS - Fondazione Pascale
Arms of the Study
Arm 1
Experimental
Trabectedin
Trabectedin will be administered intravenously at a dose of 1.5 mg/m2 or 1.3 mg/m2 (at investigator's discretion, with a top-dose of 2.6 total mg per cycle) as a 24-hour infusion once every 3 weeks (cycle day 1). Since trabectedin has no cumulative toxicities, treatment can be continued until progressive disease, major toxicity, patient's intolerance or unwillingness to continue treatment or medical decision by the responsible physician. In the subgroup of patients amenable to surgery, treatment will be reasonably continued until the best dimensional response.