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

Primary Purpose

Soft-tissue Sarcomas

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Procedure/Surgery
Sponsored by
Institut Bergonié
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Soft-tissue Sarcomas focused on measuring soft-tissue sarcomas, CINSARC, biomarker, efficacy, pronostic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Institut BergoniéRecruiting
  • Centre Georges François LeclercRecruiting
  • Centre Oscar Lambret
  • Centre Léon BérardRecruiting
  • AP-HM _ Hôpital de la TimoneRecruiting
  • Institut Paoli CalmettesRecruiting
  • Institut de Cancérologie de l'OuestRecruiting
  • Institut Curie
  • Institut Claudius Regaud - IUCT-0Recruiting
  • Institut Gustave Roussy

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Procedure/Surgery

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Efficacy of neoadjuvant anthracycline based chemotherapy in terms of proportion of tumour cells identified on the surgical specimen
Association of the CINSARC signature and histological response based on the proportion of tumour cells identified on the surgical specimen
Patient's classification by CINSARC signature. Patients will be classified as either low risk CINSARC or high risk
Metastasis-free survial is defined following recent guidelines for the definition of survival endpoints in sarcoma trials (Bellera et al. Annals Oncol 2014.
3 -year Overall Survial (OS) defined as the time from study treatment initiation to death (of any cause).
Histological response is defined using both 3 histological parameters: proportion of recognizable tumor cells, fibrosis and necrosis in the surgical specimen.
Identification of molecular mechanisms involved in intrinsic resistance to chemotherapy by correlating the transcriptome data with response to chemotherapy.
Adverse events related to the biopsy procedure will be graded using the common toxicity criteria from the NCI v4.0.

Full Information

First Posted
April 29, 2016
Last Updated
March 1, 2023
Sponsor
Institut Bergonié
Collaborators
National Cancer Institute, France, Ministry of Health, France
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1. Study Identification

Unique Protocol Identification Number
NCT02789384
Brief Title
CINSARC Signature and Correlation With Hemotherapy Efficacy in Soft-tissue Sarcomas. A Biomarker Study.
Acronym
NEOSarcomics
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 )
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 2016 (Actual)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
August 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Bergonié
Collaborators
National Cancer Institute, France, Ministry of Health, France

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Soft-tissue Sarcomas
Keywords
soft-tissue sarcomas, CINSARC, biomarker, efficacy, pronostic

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
205 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Procedure/Surgery
Arm Type
Experimental
Arm Description
Newly obtained biopsy if applicable and blood samples collection according to the usual medical practices.
Intervention Type
Other
Intervention Name(s)
Procedure/Surgery
Intervention Description
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 Measure Information:
Title
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 Measure Information:
Title
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
Title
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
Title
Patient's classification by CINSARC signature. Patients will be classified as either low risk CINSARC or high risk
Time Frame
6 months
Title
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
Title
3 -year Overall Survial (OS) defined as the time from study treatment initiation to death (of any cause).
Time Frame
3 years
Title
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
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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). Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Antoine ITALIANO, MD,PhD
Email
a.italiano@bordeaux.unicancer.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Simone MATHOULIN-PELISSIER, MD,PhD
Email
s.mathoulin@bordeaux.unicancer.fr
Facility Information:
Facility Name
Institut Bergonié
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antoine ITALIANO, MD,PhD
Email
a.italiano@bordeaux.unicancer.fr
First Name & Middle Initial & Last Name & Degree
ITALIANO Antoine, MD,PhD
Facility Name
Centre Georges François Leclerc
City
Dijon Cedex
ZIP/Postal Code
21079
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicolas ISAMBERT
First Name & Middle Initial & Last Name & Degree
ISAMBERT Nicolas, MD
Facility Name
Centre Oscar Lambret
City
Lille Cedex
ZIP/Postal Code
59020
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
PENEL Nicolas, MD
Facility Name
Centre Léon Bérard
City
Lyon Cedex 08
ZIP/Postal Code
69373
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Yves BLAY, MD, PhD
Email
jean-yves.blay@lyon.unicancer.fr
First Name & Middle Initial & Last Name & Degree
BLAY Jean-Yves, MD,PhD
Facility Name
AP-HM _ Hôpital de la Timone
City
Marseille Cedex 05
ZIP/Postal Code
13385
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Florence DUFFAUD, MD, PhD
Email
florence.duffaud@ap-hm.fr
First Name & Middle Initial & Last Name & Degree
DUFFAUD Florence, MD,PhD
Facility Name
Institut Paoli Calmettes
City
Marseille Cedex 9
ZIP/Postal Code
13273
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
François BERTUCCI, MD
Email
bertuccif@ipc.unicancer.fr
First Name & Middle Initial & Last Name & Degree
BERTUCCI François, MD,PhD
Facility Name
Institut de Cancérologie de l'Ouest
City
Nantes
ZIP/Postal Code
44805
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emmanuelle BOMPAS, MD
Email
emmanuelle.bompas@ico.unicancer.fr
First Name & Middle Initial & Last Name & Degree
Emmanuelle BOMPAS, MD
Facility Name
Institut Curie
City
Paris Cedex
ZIP/Postal Code
75005
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
PIPERNO-NEUMANN Sophie, MD
Facility Name
Institut Claudius Regaud - IUCT-0
City
Toulouse Cedex 9
ZIP/Postal Code
31052
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christine CHEVREAU, MD
Email
chevreau.christine@iuct-oncopole.fr
First Name & Middle Initial & Last Name & Degree
CHEVREAU Christine, MD
Facility Name
Institut Gustave Roussy
City
Villejuif Cedex
ZIP/Postal Code
94805
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
LECESNE Axel, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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