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

Léon Bérard Center

Status: Enrolling

Conditions: Soft Tissue Sarcomas

Treatments: Radiation: pre-operative radiation; Procedure: Standard surgery after rpreoprative radiation

Study type: Observational

Funder types: Other

Identifiers

NCT05739084

GDPR registration Number (Other Identifier)

ET21-240 [RADIOSARC]

Details and patient eligibility

About

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

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

300 participants in 2 patient groups

Retrospective cohort

Description:

A total sample size of 200 patients is expected in the retrospective thanks to the NETSARC/ CONTICABASE databases (French sarcoma reference network)

Treatment:

Procedure: Standard surgery after rpreoprative radiation

Radiation: pre-operative radiation

Prospective cohort

Description:

To ensure an external validation, patients from NETsarc centers experiencing preoperative RT will be prospectively accrued and transcriptomic signature will be tested. Up to 100 patients will be enrolled in this prospective cohort.

Treatment:

Procedure: Standard surgery after rpreoprative radiation

Radiation: pre-operative radiation