AzTrials
AzTrials

Soft-tissue SarcomasNEOSarcomicsNCT02789384

CINSARC Signature and Correlation With Hemotherapy Efficacy in Soft-tissue Sarcomas. A Biomarker Study.

A study testing Procedure/Surgery in people with Soft-tissue Sarcomas, run by Institut Bergonié at 10 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This is a prospective observational biomarker study including patients with non-metastatic, soft-tissue sarcomas (STS) for whom neoadjuvant chemotherapy is considered as the best option by the multidisciplinary sarcoma team of one of the participating centers. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Soft-tissue Sarcomas
What is being tested?
Procedure/Surgery
Could I receive a placebo?
No, everyone receives an active treatment
How many people
205 participants
Where
10 sitesFrance
Study dates
Jun 2016to Dec 2027
Phase
Interventional
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed soft-tissue sarcoma by central review, except if the diagnosis was already confirmed by the RRePS (Réseau de Référence en Pathologie des Sarcomes et des Viscères) Network,
  • Available archived frozen tumor tissue sample or patient consenting to undergo a biopsy of the tumour for research purpose,
  • Non-metastatic disease, for which the use of chemotherapy to "downstage" the sarcoma prior to surgery, is assumed to result in better local tumor control by the multidisciplinary sarcoma team of one of the French reference centers involved in this study,
  • Age ≥ 18 years,
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 1,
  • Measurable disease according to RECIST v1.1 outside any previously irradiated field,
Show all 10Show fewer
  • Neoadjuvant anthracycline-based chemotherapy proposed as the best option by the multidisciplinary sarcoma team of one of the French reference centers involved in this study,
  • No prior or concurrent malignant disease diagnosed or treated in the last 2 years except for adequately treated in situ carcinoma of the cervix, basal or squamous skin cell carcinoma, or in situ transitional bladder cell carcinoma,
  • Voluntarily signed and dated written informed consents prior to any study specific procedure,
  • Patients with a social security in compliance with the French Law relating to biomedical research (Article 1121-11 of French Public Health Code).

Who cannot join

  • Pathological diagnosis different from a soft-tissue sarcoma,
  • Histological subtypes: well-differentiated liposarcoma, alveolar soft-part sarcoma, dermatofibrosarcoma protuberans, clear-cell sarcoma, rhabdomyosarcoma,
  • Previous treatment for the sarcoma,
  • Contra-indication precluding the administration of chemotherapy as assessed by the investigator,
  • Participation to a study involving a medical or therapeutic intervention in the last 30 days,
  • Previous enrolment in the present study,
  • Pregnant or breast feeding women,
  • Patient unable to follow and comply with the study procedures because of any geographical, social or psychological reasons.

Trial locations and contacts

10 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Antoine ITALIANO, MD,PhD contact

a.italiano@bordeaux.unicancer.fr

Simone MATHOULIN-PELISSIER, MD,PhD contact

s.mathoulin@bordeaux.unicancer.fr

10 sites in 1 country

France10 sites, 10 recruiting

  • Institut Bergonié

    Bordeaux, 33076

    Antoine ITALIANO, MD,PhD, a.italiano@bordeaux.unicancer.fr

    ITALIANO Antoine, MD,PhD

    Recruiting

  • Centre Georges François Leclerc

    Dijon, 21079

    Nicolas ISAMBERT

    ISAMBERT Nicolas, MD

    Recruiting

  • Centre Oscar Lambret

    Lille, 59020

    PENEL Nicolas, MD

    Not yet recruiting

  • Centre Léon Bérard

    Lyon, 69373

    Jean-Yves BLAY, MD, PhD, jean-yves.blay@lyon.unicancer.fr

    BLAY Jean-Yves, MD,PhD

    Recruiting

  • Institut Paoli Calmettes

    Marseille, 13273

    François BERTUCCI, MD, bertuccif@ipc.unicancer.fr

    BERTUCCI François, MD,PhD

    Recruiting

  • AP-HM _ Hôpital de la Timone

    Marseille, 13385

    Florence DUFFAUD, MD, PhD, florence.duffaud@ap-hm.fr

    DUFFAUD Florence, MD,PhD

    Recruiting

  • Institut de Cancérologie de l'Ouest

    Nantes, 44805

    Emmanuelle BOMPAS, MD, emmanuelle.bompas@ico.unicancer.fr

    Emmanuelle BOMPAS, MD

    Recruiting

  • Institut Curie

    Paris, 75005

    PIPERNO-NEUMANN Sophie, MD

    Not yet recruiting

  • Institut Claudius Regaud - IUCT-0

    Toulouse, 31052

    Christine CHEVREAU, MD, chevreau.christine@iuct-oncopole.fr

    CHEVREAU Christine, MD

    Recruiting

  • Institut Gustave Roussy

    Villejuif, 94805

    LECESNE Axel, MD

    Not yet recruiting

Other trials in France

About this study

Official title: Prognostic Value of the CINSARC (Complexity Index in Sarcoma) Signature and Correlation With Chemotherapy Efficacy in Soft-tissue Sarcomas. A Biomarker Study. (NEOSarcomics )

This is a prospective observational biomarker study including patients with non-metastatic, soft-tissue sarcomas (STS) for whom neoadjuvant chemotherapy is considered as the best option by the multidisciplinary sarcoma team of one of the participating centers.

Read the detailed description

Even when retrospective statistical identification for a biomarker has been achieved, the ultimate proof of its usefulness in the clinic still requires prospective evidence. Our prospective study aims to validate the prognosis value of the CINSARC signature in a prospective way. Moreover, the neoadjuvant setting is an ideal one to identify molecular predictive factors of sensitivity to chemotherapy by correlating tumor response with genetic profile of STS. Moreover, molecular profiling of treatment-refractory tumor cells may reveal alterations that are associated with drug resistance, metastatic recurrence and disease progression. The identifications of such factors in the neoadjuvant setting may help to improve the management of STS patients in the adjuvant and metastatic settings

Being tested
Procedure/Surgery
Keywords
soft-tissue sarcomas, CINSARC, biomarker, efficacy, pronostic
Medical subject headings
Sarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Procedure/SurgeryOther

    Procedure/Surgery: Newly obtained biopsy if applicable and Blood samples collection.

    For each patient:

    • Frozen and paraffin embedded tumor material (archival or new biopsy) will be obtained for genetic profiling
    • Blood samples will be obtained for genetic profiling and assessment of markers.

    The classification as CINSARC will be performed for each patient. Patients should be treated by neoadjuvant anthracycline-based chemotherapy. Chemotherapy regimen must contain at least doxorubicin (dose range: 60 -75 mg/m²) and ifosfamide (dose range: 2.5-3g/m²) to be delivered on a 21-days cycle basis up to 6 cycles prior surgery. After neoadjuvant chemotherapy completion, patients will be treated by surgery followed or not by radiotherapy.

    All patients should be managed according to the usual medical practices.

Study groups in NCT02789384
Study groupRoleWhat they receive
Procedure/SurgeryExperimentalNewly obtained biopsy if applicable and blood samples collection according to the usual medical practices.
Receives: Other: Procedure/Surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Assessment of antitumor activity of neoadjuvant anthracycline based chemotherapy. Efficacy will be defined based on complete response, partial response and stable disease observed during treatment following RECIST v1.1 criteria.

    Measured: participants will be followed for the duration of treatment, an expected average of 6-months

Secondary outcomes (8)

  1. Efficacy of neoadjuvant anthracycline based chemotherapy in terms of proportion of tumour cells identified on the surgical specimen

    Measured: an expected average of 6 months

  2. Association of the CINSARC signature and histological response based on the proportion of tumour cells identified on the surgical specimen

    Measured: an expected average of 6 months

  3. Patient's classification by CINSARC signature. Patients will be classified as either low risk CINSARC or high risk

    Measured: 6 months

  4. Metastasis-free survial is defined following recent guidelines for the definition of survival endpoints in sarcoma trials (Bellera et al. Annals Oncol 2014.

    Measured: 3 years

  5. 3 -year Overall Survial (OS) defined as the time from study treatment initiation to death (of any cause).

    Measured: 3 years

  6. Histological response is defined using both 3 histological parameters: proportion of recognizable tumor cells, fibrosis and necrosis in the surgical specimen.

    Measured: an expected average of 6 months

  7. Identification of molecular mechanisms involved in intrinsic resistance to chemotherapy by correlating the transcriptome data with response to chemotherapy.

    Measured: an expected average of 6 months

  8. Adverse events related to the biopsy procedure will be graded using the common toxicity criteria from the NCI v4.0.

    Measured: during 7 days after biopsy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jun 2016 (estimated)
  2. Study startJun 2016
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

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 N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
205 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02789384
Sponsor's protocol ID
IB 2015-07
Other IDs
ID-RCB 2015-A01969-40
Acronym
NEOSarcomics
Status last verified
Oct 2026
First submitted
29 Apr 2016
Last updated
8 Oct 2026
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • Guegan JP, El Ghazzi N, Vibert J, Rey C, Vanhersecke L, Coindre JM, Toulmonde M, Spalato Ceruso M, Peyraud F, Bessede A, Italiano A. Predictive value of tumor microenvironment on pathologic response to neoadjuvant chemotherapy in patients with undifferentiated pleomorphic sarcomas. J Hematol Oncol. 2024 Oct 23;17(1):100. doi: 10.1186/s13045-024-01614-w.

    PubMed 39444039

Questions about this trial

What is this clinical trial studying?

A study testing Procedure/Surgery in people with Soft-tissue Sarcomas, run by Institut Bergonié at 10 sites in France.

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 10 inclusion and 8 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 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in France. 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.

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 Antoine ITALIANO, MD,PhD (a.italiano@bordeaux.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assessment of antitumor activity of neoadjuvant anthracycline based chemotherapy. Efficacy will be defined based on complete response, partial response and stable disease observed during treatment following RECIST v1.1 criteria. (time frame: participants will be followed for the duration of treatment, an expected average of 6-months). 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 NCT02789384, which also lists 1 linked publication.

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 8 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in