Clinical trial · Interventional
Hypofractionated vs Conventional Fractionated RT in Soft Tissue Sarcomas
Phase II Trial of Neoadjuvant Hypofractionated Radiotherapy Versus Conventionally Fractionated Radiotherapy for Soft Tissue Sarcomas
NCT05109494CI-TRIAL-00116995suspendedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Administrative
Summary
Brief summary (as posted)
This research study is designed to find out if radiation therapy treatment prior to surgery is safe and effective to treat soft tissue sarcomas. 30 participants with soft tissue sarcoma will be enrolled and can expect to be on study for up to 5 years.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Conventional Fractionated | Radiation | — | UNRESOLVED |
| Hypofractionated | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Conventional Fractionated
- description
- radiation treatments will be delivered daily, delivered over a maximum of 7 weeks from the first treatment, surgery will be within 5-14 days of completion of RT
- interventionNames
- Radiation: Conventional Fractionated
- type
- EXPERIMENTAL
- label
- Hypofractionated
- description
- the maximum frequency of treatment will be every day and the minimum frequency will be every other day, delivered over a maximum of 3 weeks from the first treatment, surgery will be within 5-14 days of completion of RT
- interventionNames
- Radiation: Hypofractionated
Primary outcomes (1)
- measure
- Pathologic Necrosis Score on Surgical Pathology Report
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Biopsy proven soft tissue sarcoma of the extremity, trunk, or head and neck * No prior sarcoma-directed chemotherapy or radiotherapy * Age ≥ 18 years * Karnofsky performance status ≥ 60 * Able to understand and sign an informed consent * Life expectancy of greater than 12 weeks * Hypofractionated or conventionally fractionated radiotherapy using Intensity Modulated Radiation Therapy (IMRT) are both deemed feasible and safe neoadjuvant treatments, at the treating physician's discretion * Operable disease and medically fit for surgery, based on the opinion of the consulting surgeon; surgery within 5-14 days of completion of radiation therapy (RT) * Adequate bone marrow function as defined by absolute neutrophil count \> 500/mcL, hemoglobin \> 8 g/dL, platelets \> 50,000/mcL; adequate renal function as defined by creatinine clearance \> 30 mL/min Exclusion Criteria: * Pregnant * Unable to undergo imaging or positioning necessary for radiotherapy planning
References
Publications (0)
Data not yet available
No reference posted for this study.