Prospective, uncontrolled, investigator-initiated, phase II clinical study to explore the activity of trabectedin in a population of patients aged ≥16 years with progressive, advanced (locally advanced or metastatic)
Prospective, uncontrolled, multicenter, Italian, investigator-initiated, phase II clinical study to explore the activity of trabectedin in a population of patients aged ≥16 years with progressive, advanced (locally advanced or metastatic), HEY1-NCOA2 positive MCS) , pre-treated with anthracycline-based chemotherapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Treatment with trabectedin: 1.5 mg/m² - 1.3 mg/m² (at investigator's discretion, with a top-dose of 2.6 total mg per cycle), given in 24-hour continuous infusion
Nuovo Ospedale di Prato
Prato, Firenze, Italy
RECRUITINGPoliclinico Universitario Campus Biomedico
Roma, RM, Italy
NOT_YET_RECRUITINGFondazione del Piemonte per l'Oncologia IRCC Candiolo
Candiolo, Torino, Italy
Overall tumour Response Rate, according to RECIST v 1.
Response rate according Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Time frame: At weeks 6
Choi criteria response rate
Response rate according Choi criteria
Time frame: At weeks 6, 12,18, 30, 42
Overall Survival
Proportion of patients who are still alive at 36 and 60 months after have started the treatment
Time frame: At 3 and 5 years
Progression Free Survival (PFS)
Survival without disease progression
Time frame: At 3 and 5 years
Clinical Benefit Rate
Proportion of patient alive, without disease progression, after 6 months of treatment.
Time frame: Month 6
Duration of response
Duration of time between the date of first documented response and the date of first documented progression or death due to any cause
Time frame: At weeks 6, 12,18, 30, 42
Adverse events related to the treatment
Safety in term of grading of adverse event is evaluate from the first treatment dose throughout the study according to CTCAE 5.0
Time frame: Week 3, week 6, week 9, week 12, week 18, week 24, week 36, week 48, week 60, week 72
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Istituto Ortopedico Rizzoli - Unit of Chemotherapy of Muscoloskeletal Tumors
Bologna, Italy
RECRUITINGFondazione IRCSS Istituto Nazionale dei Tumori
Milan, Italy
RECRUITINGOspedale Giaccone
Palermo, Italy
RECRUITINGIstituti Fisioterapici Ospitalieri - Ospedale Regina Elena
Roma, Italy
RECRUITING