Actively Recruiting
Trial in Patients With Metastatic or Locally Advanced Leiomyosarcoma
Led by Italian Sarcoma Group · Updated on 2026-03-25
100
Participants Needed
17
Research Sites
269 weeks
Total Duration
On this page
Sponsors
I
Italian Sarcoma Group
Lead Sponsor
P
PharmaMar
Collaborating Sponsor
AI-Summary
What this Trial Is About
Study is aimed at evaluating the activity of Trabectedin (arm A) in advanced leiomyosarcomas, having Gemcitabine (arm B) as the comparator. In addition to the randomized cohort, the study has also an observational prospective cohort which include patients who will refuse the randomization or for whom the investigator will not judge the randomization as an appropriate option. In order to allow the participation of sites only to the prospective-observational (non randomized) cohort, it was introduced the possibility to participate to the study and receive the ethical approval only to the Observational Prospective Cohort In parallel an optional translational study will be performed, in both cohorts, to identify factors predictive of the activity of Trabectedin or Gemcitabine in this specific histotype.
CONDITIONS
Official Title
Trial in Patients With Metastatic or Locally Advanced Leiomyosarcoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed diagnosis of leiomyosarcoma
- Unresectable or metastatic leiomyosarcoma
- At least one prior systemic treatment with anthracycline-based chemotherapy
- Suitable to receive Trabectedin or Gemcitabine therapy
- Measurable or evaluable disease according to RECIST 1.1 criteria
- Disease progression documented within 6 months before study entry
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less
- All previous anticancer treatments completed at least 3 weeks before starting study drug
- Resolution of adverse events from prior therapies to grade 1 or less, except alopecia
- Adequate bone marrow, liver, and kidney function
- Left ventricular ejection fraction of 50% or higher, or above institutional lower limit
- Female patients of child-bearing potential with negative pregnancy test within 7 days before each chemotherapy cycle
- No arterial or venous thromboembolic events in the past 12 months
- Ability to read, understand, and provide written informed consent, with optional consent for biological sub-study
You will not qualify if you...
- Previous treatment with Trabectedin or Gemcitabine
- Known allergy to study drugs or their components
- History of other cancers unless disease-free for 5 years or more (except treated basal cell carcinoma or cervical carcinoma in situ)
- Ongoing toxicities from prior cancer treatments above grade 1, except alopecia
- Presence of metastatic brain or meningeal tumors
- Active viral hepatitis infection
- Immunocompromised status, including HIV positive
- Severe or uncontrolled medical conditions
- History of grade 3 or higher bleeding events within 4 weeks before study treatment
- Active serious infections
- Radiation therapy within 14 days before starting study drug
- Major surgery within 4 weeks before study entry
- Use of strong or moderate CYP3A inhibitors or inducers
- Renal dialysis or creatinine clearance below 30 ml/min or creatinine above 1.5 mg/dL
- Pregnant or breastfeeding women
- Severe or uncontrolled concurrent medical diseases posing safety risks or compliance issues
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 17 locations
1
Azienda Ospedaliera S. Orsola-Malpighi
Bologna, BO, Italy, 40138
Actively Recruiting
2
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori - IRST
Meldola, FC, Italy
Actively Recruiting
3
Nuovo Ospedale di Prato
Prato, Firenze, Italy, 59100
Actively Recruiting
4
Istituto Clinico Humanitas
Rozzano, MI, Italy, 20089
Actively Recruiting
5
Centro di Riferimento Oncologico di Aviano
Aviano, PD, Italy, 33081
Not Yet Recruiting
6
Policlinico Universitario Campus Biomedico
Roma, RM, Italy, 00128
Actively Recruiting
7
IRCCS Fondazione Piemonte per l'Oncologia
Candiolo, Torino, Italy, 10060
Actively Recruiting
8
A.O.U.San Luigi Gonzaga
Orbassano, Torino, Italy, 10043
Actively Recruiting
9
Istituto Ortopedico Rizzoli - Unit of Chemotherapy of Muscoloskeletal Tumors
Bologna, Italy, 40136
Actively Recruiting
10
H.San Martino di Genova
Genova, Italy
Actively Recruiting
11
Fondazione IRCCS INT Milano
Milan, Italy, 20133
Not Yet Recruiting
12
Istituto Europeo di Oncologia
Milan, Italy
Actively Recruiting
13
IRCCS Istituto nazionale Tumori "Fondazione G.Pascale"
Naples, Italy
Actively Recruiting
14
Irccs Istituto Oncologico Veneto (Iov)
Padova, Italy
Actively Recruiting
15
Ospedale Giaccone
Palermo, Italy
Actively Recruiting
16
Istituto Regina Elena - IFO
Rome, Italy, 00100
Actively Recruiting
17
ASL Città di Torino (Dipartimento di Oncologia)
Torino, Italy, 10153
Actively Recruiting
Research Team
B
Bruno Vincenzi, Prof/MD
CONTACT
E
Emanuela Marchesi, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here