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

Soft Tissue Sarcomas Clinical Trial

— RADIOSARC  

Official title:

[RADIOSARC] Searching for Specific Gene Signature(s) of Sensitivity/Resistance to Neoadjuvant Radiotherapy in Adults Patients With Resectable Soft Tissue Sarcomas of Limbs

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05739084
• Other study ID #: ET21-240 [RADIOSARC]
• Secondary ID: GDPR registratio
• Status: Recruiting
• Start date: November 23, 2022
• Est. completion date: November 23, 2025

Study information

• Verified date: February 2023
• Source: Centre Leon Berard
• Contact: Marie -Pierre SUNYACH, MD
• Phone: +33(0)4 78 78 28 28
• Email: MariePierre.SUNYACH[@]lyon.unicancer.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: November 23, 2025
• Est. primary completion date: June 23, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Sarcoma
• Soft Tissue Sarcomas

Intervention

Radiation:
• pre-operative radiation
As per standard of care and institutional guidelines

Procedure:
• Standard surgery after rpreoprative radiation
As per standard of care and institutional guidelines

Locations

Country	Name	City	State
France	Centre Léon Bérard	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Leon Berard

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	36 months
Secondary	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.	36 months