NCT02789384

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
205

participants targeted

Target at P75+ for not_applicable

Timeline
19mo left

Started Jun 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

10 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress86%
Jun 2016Dec 2027

First Submitted

Initial submission to the registry

April 29, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 3, 2016

Completed
10.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

December 2, 2025

Status Verified

November 1, 2025

Enrollment Period

10.5 years

First QC Date

April 29, 2016

Last Update Submit

November 24, 2025

Conditions

Soft-tissue Sarcomas

Keywords

soft-tissue sarcomasCINSARCbiomarkerefficacypronostic

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (8)

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

    an expected average of 6 months

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

    an expected average of 6 months

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

    6 months

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

    3 years

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

    3 years

  • +3 more secondary outcomes

Study Arms (1)

Procedure/Surgery

EXPERIMENTAL

Newly obtained biopsy if applicable and blood samples collection according to the usual medical practices.

Other: Procedure/Surgery

Interventions

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.

Procedure/Surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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,
  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Institut Bergonié

Bordeaux, 33076, France

RECRUITING

Centre Georges François Leclerc

Dijon, 21079, France

RECRUITING

Centre Oscar Lambret

Lille, 59020, France

NOT YET RECRUITING

Centre Léon Bérard

Lyon, 69373, France

RECRUITING

Institut Paoli Calmettes

Marseille, 13273, France

RECRUITING

AP-HM _ Hôpital de la Timone

Marseille, 13385, France

RECRUITING

Institut de Cancérologie de l'Ouest

Nantes, 44805, France

RECRUITING

Institut Curie

Paris, 75005, France

NOT YET RECRUITING

Institut Claudius Regaud - IUCT-0

Toulouse, 31052, France

RECRUITING

Institut Gustave Roussy

Villejuif, 94805, France

NOT YET RECRUITING

Related Publications (1)

  • 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.

    PMID: 39444039DERIVED

MeSH Terms

Conditions

Sarcoma

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Central Study Contacts

Antoine ITALIANO, MD,PhD

CONTACT

a.italiano@bordeaux.unicancer.fr

Simone MATHOULIN-PELISSIER, MD,PhD

CONTACT

s.mathoulin@bordeaux.unicancer.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2016

First Posted

June 3, 2016

Study Start

June 1, 2016

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2027

Last Updated

December 2, 2025

Record last verified: 2025-11

Locations

FR(10)