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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02789384
Recruitment Status : Recruiting
First Posted : June 3, 2016
Last Update Posted : September 18, 2018
National Cancer Institute, France
Ministry of Health, France
Information provided by (Responsible Party):
Institut Bergonié

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.

Condition or disease Intervention/treatment Phase
Soft-tissue Sarcomas Other: Procedure/Surgery Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 205 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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 )
Actual Study Start Date : June 2016
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Procedure/Surgery
Newly obtained biopsy if applicable and blood samples collection according to the usual medical practices.
Other: Procedure/Surgery

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.

Primary Outcome Measures :
  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. [ Time Frame: participants will be followed for the duration of treatment, an expected average of 6-months ]

Secondary Outcome Measures :
  1. Efficacy of neoadjuvant anthracycline based chemotherapy in terms of proportion of tumour cells identified on the surgical specimen [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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. [ Time Frame: 3 years ]
  5. 3 -year Overall Survial (OS) defined as the time from study treatment initiation to death (of any cause). [ Time Frame: 3 years ]
  6. Histological response is defined using both 3 histological parameters: proportion of recognizable tumor cells, fibrosis and necrosis in the surgical specimen. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: during 7 days after biopsy ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. 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,
  2. Available archived frozen tumor tissue sample or patient consenting to undergo a biopsy of the tumour for research purpose,
  3. 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,
  4. Age ≥ 18 years,
  5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 1,
  6. Measurable disease according to RECIST v1.1 outside any previously irradiated field,
  7. 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,
  8. 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,
  9. Voluntarily signed and dated written informed consents prior to any study specific procedure,
  10. Patients with a social security in compliance with the French Law relating to biomedical research (Article 1121-11 of French Public Health Code).

Exclusion Criteria:

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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02789384

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Contact: Antoine ITALIANO, MD,PhD

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Institut Bergonié Recruiting
Bordeaux, France, 33076
Contact: Antoine ITALIANO, MD,PhD         
Principal Investigator: ITALIANO Antoine, MD,PhD         
Centre Georges François Leclerc Not yet recruiting
Dijon Cedex, France, 21079
Principal Investigator: ISAMBERT Nicolas, MD         
Centre Oscar Lambret Not yet recruiting
Lille Cedex, France, 59020
Principal Investigator: PENEL Nicolas, MD         
Centre Léon Bérard Not yet recruiting
Lyon Cedex 08, France, 69373
Principal Investigator: BLAY Jean-Yves, MD,PhD         
AP-HM _ Hôpital de la Timone Not yet recruiting
Marseille Cedex 05, France, 13385
Principal Investigator: DUFFAUD Florence, MD,PhD         
Institut Paoli Calmettes Not yet recruiting
Marseille Cedex 9, France, 13273
Principal Investigator: BERTUCCI François, MD,PhD         
Institut de Cancérologie de l'Ouest Not yet recruiting
Nantes, France, 44805
Principal Investigator: BOMPAS Emmanuel, MD         
Institut Curie Not yet recruiting
Paris Cedex, France, 75005
Principal Investigator: PIPERNO-NEUMANN Sophie, MD         
Institut Claudius Regaud - IUCT-0 Not yet recruiting
Toulouse Cedex 9, France, 31052
Principal Investigator: CHEVREAU Christine, MD         
Institut Gustave Roussy Not yet recruiting
Villejuif Cedex, France, 94805
Principal Investigator: LECESNE Axel, MD         
Sponsors and Collaborators
Institut Bergonié
National Cancer Institute, France
Ministry of Health, France

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Responsible Party: Institut Bergonié Identifier: NCT02789384     History of Changes
Other Study ID Numbers: IB 2015-07
First Posted: June 3, 2016    Key Record Dates
Last Update Posted: September 18, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Institut Bergonié:
soft-tissue sarcomas

Additional relevant MeSH terms:
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Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type