Clinical trial · Observational
Gene Signatures Searching of Sensitivity/Resistance to Neoadjuvant Radiotherapy in Patients With Resectable STS
[RADIOSARC] Searching for Specific Gene Signature(s) of Sensitivity/Resistance to Neoadjuvant Radiotherapy in Adults Patients With Resectable Soft Tissue Sarcomas of Limbs
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Soft Tissue Sarcomas | Soft Tissue Sarcoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| pre-operative radiation | Radiation | — | UNRESOLVED |
| Standard surgery after rpreoprative radiation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- 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)
- interventionNames
- Radiation: pre-operative radiation
- Procedure: Standard surgery after rpreoprative radiation
- label
- 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.
- interventionNames
- Radiation: pre-operative radiation
- Procedure: Standard surgery after rpreoprative radiation
Primary outcomes (1)
- measure
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available