Clinical trial · Interventional
Feasibility Trial of Preoperative 5-Day Hypofractionated Radiotherapy for Primary Soft Tissue Sarcoma
- 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)
This study is investigating the feasibility of preoperative 5-day hypofractionated radiotherapy (HFRT) for extremity soft tissue sarcoma (STS). The primary objective is to assess the uptake of 5-day HFRT in patients with STS who are candidates for preoperative radiotherapy and limb preserving surgery. Secondary objectives include evaluation of the rates of favorable pathologic response, major wound complications, local control, acute toxicity, and 1-year late toxicity will be assessed. Exploratory objectives include evaluation of the impact of preoperative 5-day HFRT on access to care, the socio-demographic profile of the trial participants will be compared to that of extremity STS patients seen within Hollings Cancer Center (HCC) and recommended preoperative conventional fractionation radiotherapy (CFRT) in the 3 years prior to the study opening. The retention rate for radiotherapy at HCC in patients meeting trial criteria during the prior 3 years will be compared with the retention rate for radiotherapy during the study period. An exploratory analysis will measure serum SFRP2 pre- and post- radiotherapy to assess changes in response to preoperative 5-day HFRT. Changes in serum SFRP2 will be evaluated for association with a favorable pathologic response to determine the potential of serum SFRP2 as a predictive biomarker. Patient satisfaction with the decision to participate in a trial of preoperative 5-day HFRT will be assessed.
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 Sarcoma | Soft Tissue Sarcoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hypofractionated Radiation Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Hypofractionated Radiation Therapy
- interventionNames
- Radiation: Hypofractionated Radiation Therapy
Primary outcomes (1)
- measure
- Feasibility of 5-day HFRT
- timeFrame
- Up to 3 years
- description
- The preoperative 5-day HFRT uptake rate, defined as the proportion of eligible patients who elect to participate in the trial.
Secondary outcomes (5)
- measure
- Rate of favorable pathologic response
- timeFrame
- Up to 3 years
- description
- Proportion of patients with extent of tumor fibrosis/hyalinization and infarct \> 12.5%
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. AJCC 8th edition stage I-III histologically confirmed STS of the extremity or trunk 2. Male or female, aged \> 18 years old 3. ECOG Performance Status 0-3 4. Meets screening criteria for receipt of radiotherapy 5. Deemed eligible for wide local excision Exclusion Criteria: 1. Distant metastatic disease 2. Prior radiation therapy in the proposed treatment area 3. Simultaneous treatment of another malignancy 4. Planned neoadjuvant or adjuvant chemotherapy
References
Publications (0)
Data not yet available