Gene Signatures Searching of Sensitivity/Resistance to Neoadjuvant Radiotherapy in Patients With Resectable STS

Centre Leon Berard300 enrolled

Overview

To date, the radiation oncologist are missing biomarkers predictive of response/resistance to RT in order to identify patients who may benefit from RT and personalize the RT schedule. Our proposal is to conduct a cohort study aiming at identifying transcriptomic biomarkers predictive of sensitivity and/or resistance to RT in limbs STS patients

Whether RT should be performed pre or post-operatively is still a debated question. To date, the radiation oncologist are missing signature of response/resistance to RT in order to identify patients who may benefit from RT and personalize the RT schedule. Therefore, predicting the likelihood of response/resistance to RT is essential. The individual exploration with high-throughput approaches will participate in describing biological mechanisms involved in STS tumor cell pan-resistance, thus identifying potential molecular targets that could be inhibited to reverse intrinsic radioresistance. In this context, our proposal is to conduct a cohort study aiming at identifying transcriptomic signature predictive of sensitivity and/or resistance to RT in limbs STS patients.

Study Type

OBSERVATIONAL

Enrollment

300

Conditions

Soft Tissue Sarcomas

Interventions

pre-operative radiationRADIATION

As per standard of care and institutional guidelines

Standard surgery after rpreoprative radiationPROCEDURE

As per standard of care and institutional guidelines

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male and female ≥ 18 years at time of non-opposition to participate to the study * Patient with documented non-opposition to participate to the study. * Patient with histologically and cytologically confirmed diagnosis with STS (..) * Patient with availability of FFPE tumor block from initial diagnosis biopsy (mandatory) and surgery specimen (optional). * Patients with tumor FFPE samples prepared with the last 4 years * Patient with evaluable tumor sample meeting the following quality/quantity control criteria (..) Exclusion Criteria: * Patients with metastatic soft tissue sarcoma at diagnosis * Patients with exclusive radiotherapy without surgical resection * Patients receiving neo adjuvant systemic treatment (chemotherapy, immunotherapy, targeted therapy)

Locations (1)

Centre Léon Bérard

Lyon, France

RECRUITING

Outcomes

Primary Outcomes

To define a transcriptomic signature of histological response to radiotherapy in STS patients using the percentage of residual viable cells as a clinical meaningful endpoint

Gene expression signature using RNAseq correlated to the percentage of residual viable cells on surgery specimen to define histological response.

Time frame: 36 months

Secondary Outcomes

To identify biomarkers of sensitivity or resistance to radiotherapy in STS patients using additional clinical endpoints

Gene expression signature using RNAseq correlated to the percentage of necrosis, the percentage of fibrosis, the local control at 1 and 2 years (1- and 2-year local / distant recurrence-free survival, the time To Relapse (TTR), the Disease Free Survival (DFS), The Quality of resection level based on the residual tumor (R) classification.

Time frame: 36 months

Central Contacts

Marie -Pierre SUNYACH, MD

CONTACT

+33(0)4 78 78 28 28 MariePierre.SUNYACH@lyon.unicancer.fr

Waisse Waissi, MD

CONTACT

+33(0)4 78 78 28 28 Waisse.WAISSI@lyon.unicancer.fr

Data from ClinicalTrials.gov

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