Clinical trial · Interventional
Preoperative 5-Day Radiotherapy for Soft Tissue Sarcoma
Preoperative 5-Day Radiotherapy for Soft Tissue Sarcoma: A Single Institution Phase II Trial
NCT06905132CI-TRIAL-00106726recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
The purpose of this research study is to preserve healthy tissue around the cancer on the arm(s) and/or leg(s) using Hypofractionated radiotherapy, while treating the cancer and preventing it from spreading to other areas of the body.
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
- HFRT Safety
- timeFrame
- 6 months
- description
- Evaluate the safety of 5-day HFRT as measured by the rates of major wound complications occurring within 120 days of surgery.
Secondary outcomes (2)
- measure
- Treatment Response
- timeFrame
- 6 months
- description
- Evaluate treatment response to 5-day HFRT as measured by pathologic response. Pathologic response is defined as percent necrosis and percent viable tumor.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Willingness and provision of informed consent via signed and dated copy. * Histologically confirmed STS of extremity or trunk. * Male or female, aged greater than or equal to 18 years old * ECOG performance status 0-3 * Meets screening criteria for receipt of radiotherapy. * Deemed eligible for wide local excision. * Patient and/or physician identified possible barriers to receiving a 5-week course of conventionally fractionated preoperative radiotherapy. Potential barriers include but are not limited to concern for local progression that could precluded or complicate limb sparing surgery, concern for distant progression that could result in patient being non-operative, financial and/or physical burden of travel for daily treatments, financial burden of time away from work or caregiving. Exclusion Criteria: * Distant metastatic disease * Prior radiation therapy in the proposed treatment area * Simultaneous treatment of another malignancy * Women who are pregnant or plan to become pregnant during the period of radiation therapy * Planned concurrent administration of chemotherapy and radiation therapy
References
Publications (0)
Data not yet available
No reference posted for this study.