Mesenchymal ChondrosarcomaPhase 2ISG-MCSNCT04305548
Study on Trabectedin in Advanced Rearranged Mesenchymal Chondrosarcoma
A Phase 2 study testing Trabectedin in people with Mesenchymal Chondrosarcoma, run by Italian Sarcoma Group at 7 sites in Italy.
Trial summary
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) Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Mesenchymal Chondrosarcoma
- What is being tested?
- Trabectedin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 7 sitesItaly
- Study dates
- 14 Sep 2021to 31 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age ≥ 16 years old
- Histological centrally confirmed diagnosis of skeletal or extra-skeletal MCS with the documented presence of HEY1-NCOA2 fusion
- Locally advanced disease and/or metastatic disease
- Measurable or evaluable disease with RECIST v1.1
- Evidence of progression by RECIST v1.1 during the 6 months before study entry
- Patients must be pre-treated with at least one prior chemotherapy treatment containing anthracyclines for the advanced phase of disease and with a maximum of 3 lines
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- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2
- Adequate bone marrow function
- Adequate organ function
- Female patients of childbearing potential must have negative pregnancy test within 7 days before initiation each cycle of chemotherapy.
- Cardiac ejection fraction ≥50% as measured by echocardiogram
- No history of arterial and/or venous thromboembolic event within the previous 12 months
- The patient or legal representative must be able to read and understand the informed consent form 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.
- Any other factors, that, at judgment of investigator, could affect the safety of the patients according to the available trabectedin safety data
Who cannot join
- Other primary malignancy with <5 years clinically assessed disease free interval, except basal cell skin cancer, cervical carcinoma in situ or other neoplasm judged to entail a low risk of relapse
- 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 2 weeks prior to study entry
- Participation in another clinical study with an investigational product, which last dose was taken less than 4 weeks prior to the start of the treatment.
- Persistent toxicities (≥ grade 2) with the exception of alopecia, caused by previous anticancer therapies.
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- Pregnancy or breast feeding
- Grade III/IV cardiac problems as defined by the New York Heart Association Criteria
- 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 brain metastasis
- Known chronic liver disease (i.e. chronic active hepatitis and cirrhosis)
- Known diagnosis oh human deficiency virus (HIV) infection
- Active or chronic hepatitis B or C requiring treatment with antiviral therapy
- Medical history of hemorrhage or a bleeding event ≥ Grade 3 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
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
Italy7 sites, 7 recruiting
- Recruiting
Istituto Ortopedico Rizzoli - Unit of Chemotherapy of Muscoloskeletal Tumors
Bologna, 40136
Toni Ibrahim, MD, +390516366 ext. 199, toni.ibrahim@ior.it
Toni Ibrahim, MD
- Recruiting
Fondazione del Piemonte per l'Oncologia IRCC Candiolo
Candiolo, Torino, 10060
Sandra Aliberti, MD, 0039-011-993 ext. 3623, sandra.aliberti@ircc.it
Giovanni Grignani, MD
- Recruiting
Fondazione IRCSS Istituto Nazionale dei Tumori
Milan, 20133
Silvia Stacchiotti, MD, +39022390, silvia.stacchiotti@istitutotumori.mi.it
Silvia Stacchiotti, MD
- Recruiting
Ospedale Giaccone
Palermo
Giuseppe Badalamenti, MD, giuseppe.badalamenti@unipa.it
Giuseppe Badalamenti, MD
- Recruiting
Nuovo Ospedale di Prato
Prato, Firenze, 59100
Giacomo G. Baldi, MD, 0039057443 ext. 4766, giacomogiulio.baldi@uslcentro.toscana.it
Giacomo G. Baldi, MD
- Not yet recruiting
Policlinico Universitario Campus Biomedico
Roma, RM, 00128
Bruno Vincenzi, MD, 003906-22541 ext. 1123, b.vincenzi@unicampus.it
Bruno Vincenzi, MD
- Recruiting
Istituti Fisioterapici Ospitalieri - Ospedale Regina Elena
Roma, 00128
Virginia Ferraresi, MD, virginia.ferraresi@ifo.it
About this study
Official title: Phase II Study on Trabectedin in Advanced Rearranged Mesenchymal Chondrosarcoma
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)
Read the detailed description
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.
- Conditions
- Mesenchymal Chondrosarcoma
- Being tested
- Trabectedin
- Medical subject headings
- Chondrosarcoma, Mesenchymal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrabectedinDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Trabectedin | Experimental | 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 Receives: Drug: Trabectedin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall tumour Response Rate, according to RECIST v 1.
Response rate according Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Measured: At weeks 6
Secondary outcomes (6)
Choi criteria response rate
Response rate according Choi criteria
Measured: 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
Measured: At 3 and 5 years
Progression Free Survival (PFS)
Survival without disease progression
Measured: At 3 and 5 years
Clinical Benefit Rate
Proportion of patient alive, without disease progression, after 6 months of treatment.
Measured: 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
Measured: 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
Measured: Week 3, week 6, week 9, week 12, week 18, week 24, week 36, week 48, week 60, week 72
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2020
- Study start14 Sep 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Mesenchymal ChondrosarcomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Italian Sarcoma Group
- Sponsor type
- Research network
- Collaborators
- PharmaMar
- Responsible party
- Sponsor
- Investigators
- Silvia Stacchiotti, MD, Principal investigator, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04305548
- Sponsor's protocol ID
- ISG-MCS
- Acronym
- ISG-MCS
- Status last verified
- Mar 2026
- First submitted
- 9 Mar 2020
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lee AF, Hayes MM, Lebrun D, Espinosa I, Nielsen GP, Rosenberg AE, Lee CH. FLI-1 distinguishes Ewing sarcoma from small cell osteosarcoma and mesenchymal chondrosarcoma. Appl Immunohistochem Mol Morphol. 2011 May;19(3):233-8. doi: 10.1097/PAI.0b013e3181fd6697.
PubMed 21084965Wang L, Motoi T, Khanin R, Olshen A, Mertens F, Bridge J, Dal Cin P, Antonescu CR, Singer S, Hameed M, Bovee JV, Hogendoorn PC, Socci N, Ladanyi M. Identification of a novel, recurrent HEY1-NCOA2 fusion in mesenchymal chondrosarcoma based on a genome-wide screen of exon-level expression data. Genes Chromosomes Cancer. 2012 Feb;51(2):127-39. doi: 10.1002/gcc.20937. Epub 2011 Oct 27.
PubMed 22034177Morioka H, Takahashi S, Araki N, Sugiura H, Ueda T, Takahashi M, Yonemoto T, Hiraga H, Hiruma T, Kunisada T, Matsumine A, Susa M, Nakayama R, Nishimoto K, Kikuta K, Horiuchi K, Kawai A. Results of sub-analysis of a phase 2 study on trabectedin treatment for extraskeletal myxoid chondrosarcoma and mesenchymal chondrosarcoma. BMC Cancer. 2016 Jul 14;16:479. doi: 10.1186/s12885-016-2511-y.
PubMed 27418251Forni C, Minuzzo M, Virdis E, Tamborini E, Simone M, Tavecchio M, Erba E, Grosso F, Gronchi A, Aman P, Casali P, D'Incalci M, Pilotti S, Mantovani R. Trabectedin (ET-743) promotes differentiation in myxoid liposarcoma tumors. Mol Cancer Ther. 2009 Feb;8(2):449-57. doi: 10.1158/1535-7163.MCT-08-0848. Epub 2009 Feb 3.
PubMed 19190116Huvos AG, Rosen G, Dabska M, Marcove RC. Mesenchymal chondrosarcoma. A clinicopathologic analysis of 35 patients with emphasis on treatment. Cancer. 1983 Apr 1;51(7):1230-7. doi: 10.1002/1097-0142(19830401)51:73.0.co;2-q.
PubMed 6825046
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study on Trabectedin in Advanced Rearranged Mesenchymal Chondrosarcoma
- ClinicalTrials.gov ID
- NCT04305548
- Acronym / sponsor ID
- ISG-MCS / ISG-MCS
- Conditions
- Mesenchymal Chondrosarcoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Italian Sarcoma GroupResearch network
- Collaborators
- PharmaMar
- Study start
- 14 Sep 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 12 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trabectedin | Experimental | Drug: TrabectedinTrabectedin: 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 |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (14 listed)
- Age ≥ 16 years old
- Histological centrally confirmed diagnosis of skeletal or extra-skeletal MCS with the documented presence of HEY1-NCOA2 fusion
- Locally advanced disease and/or metastatic disease
- Measurable or evaluable disease with RECIST v1.1
- Evidence of progression by RECIST v1.1 during the 6 months before study entry
Key exclusion criteria (17 listed)
- Other primary malignancy with <5 years clinically assessed disease free interval, except basal cell skin cancer, cervical carcinoma in situ or other neoplasm judged to entail a low risk of relapse
- 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 2 weeks prior to study entry
- Participation in another clinical study with an investigational product, which last dose was taken less than 4 weeks prior to the start of the treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TrabectedinTreatment 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 | Drug | Trabectedin |
Primary outcome
Overall tumour Response Rate, according to RECIST v 1.
Time frame: At weeks 6
Response rate according Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
6 secondary outcomes
Choi criteria response rate
Time frame: At weeks 6, 12,18, 30, 42
Overall Survival
Time frame: At 3 and 5 years
Progression Free Survival (PFS)
Time frame: At 3 and 5 years
Clinical Benefit Rate
Time frame: Month 6
Duration of response
Time frame: At weeks 6, 12,18, 30, 42
Adverse events related to the treatment
Time frame: Week 3, week 6, week 9, week 12, week 18, week 24, week 36, week 48, week 60, week 72
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Background: PubMed 21084965Lee AF, Hayes MM, Lebrun D, Espinosa I, Nielsen GP, Rosenberg AE, Lee CH. FLI-1 distinguishes Ewing sarcoma from small cell osteosarcoma and mesenchymal chondrosarcoma. Appl Immunohistochem Mol Morphol. 2011 May;19(3):233-8. doi: 10.1097/PAI.0b013e3181fd6697.
- Background: PubMed 22034177Wang L, Motoi T, Khanin R, Olshen A, Mertens F, Bridge J, Dal Cin P, Antonescu CR, Singer S, Hameed M, Bovee JV, Hogendoorn PC, Socci N, Ladanyi M. Identification of a novel, recurrent HEY1-NCOA2 fusion in mesenchymal chondrosarcoma based on a genome-wide screen of exon-level expression data. Genes Chromosomes Cancer. 2012 Feb;51(2):127-39. doi: 10.1002/gcc.20937. Epub 2011 Oct 27.
- Background: PubMed 27418251Morioka H, Takahashi S, Araki N, Sugiura H, Ueda T, Takahashi M, Yonemoto T, Hiraga H, Hiruma T, Kunisada T, Matsumine A, Susa M, Nakayama R, Nishimoto K, Kikuta K, Horiuchi K, Kawai A. Results of sub-analysis of a phase 2 study on trabectedin treatment for extraskeletal myxoid chondrosarcoma and mesenchymal chondrosarcoma. BMC Cancer. 2016 Jul 14;16:479. doi: 10.1186/s12885-016-2511-y.
- Background: PubMed 19190116Forni C, Minuzzo M, Virdis E, Tamborini E, Simone M, Tavecchio M, Erba E, Grosso F, Gronchi A, Aman P, Casali P, D'Incalci M, Pilotti S, Mantovani R. Trabectedin (ET-743) promotes differentiation in myxoid liposarcoma tumors. Mol Cancer Ther. 2009 Feb;8(2):449-57. doi: 10.1158/1535-7163.MCT-08-0848. Epub 2009 Feb 3.
- Background: PubMed 6825046Huvos AG, Rosen G, Dabska M, Marcove RC. Mesenchymal chondrosarcoma. A clinicopathologic analysis of 35 patients with emphasis on treatment. Cancer. 1983 Apr 1;51(7):1230-7. doi: 10.1002/1097-0142(19830401)51:73.0.co;2-q.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Silvia Stacchiotti, MD principal investigator
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Trabectedin in people with Mesenchymal Chondrosarcoma, run by Italian Sarcoma Group at 7 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Silvia Stacchiotti, MD (39022390 ext. 2804, silvia.stacchiotti@istitutotumori.mi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall tumour Response Rate, according to RECIST v 1. (time frame: At weeks 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04305548, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.