RADIOSARC: Gene Signatures Searching of Sensitivity/Resistance to Neoadjuvant Radiotherapy in Patients With Resectable STS
Study Details
Study Description
Brief 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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Retrospective cohort A total sample size of 200 patients is expected in the retrospective thanks to the NETSARC/ CONTICABASE databases (French sarcoma reference network) |
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
|
| Prospective cohort 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. |
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
|
Outcome Measures
Primary Outcome Measures
- 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 [36 months]
Gene expression signature using RNAseq correlated to the percentage of residual viable cells on surgery specimen to define histological response.
Secondary Outcome Measures
- To identify biomarkers of sensitivity or resistance to radiotherapy in STS patients using additional clinical endpoints [36 months]
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.
Eligibility Criteria
Criteria
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.
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Patient with histologically and cytologically confirmed diagnosis with STS (..)
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Patient with availability of FFPE tumor block from initial diagnosis biopsy (mandatory) and surgery specimen (optional).
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Patients with tumor FFPE samples prepared with the last 4 years
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Patient with evaluable tumor sample meeting the following quality/quantity control criteria (..)
Exclusion Criteria:
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Patients with metastatic soft tissue sarcoma at diagnosis
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Patients with exclusive radiotherapy without surgical resection
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Patients receiving neo adjuvant systemic treatment (chemotherapy, immunotherapy, targeted therapy)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Centre Léon Bérard | Lyon | France |
Sponsors and Collaborators
- Centre Leon Berard
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ET21-240 [RADIOSARC]
- GDPR registration Number