Clinical trial · Interventional
5-Day Preoperative Radiation for Soft Tissue Sarcoma
Phase 2 5-Day Preoperative Radiation for Soft Tissue Sarcoma
NCT06087861CI-TRIAL-00114255recruitingPhase 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 study is to examine the safety and efficacy of an abbreviated course of preoperative radiation, given over five days, for patients with soft tissue sarcoma of the extremity, trunk or retroperitoneum. This is in contrast to standard preoperative radiation, which is given over 25 days.
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 |
|---|---|---|---|
| External Beam Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- External beam radiotherapy
- description
- Patients will receive treatment with external beam radiotherapy at a total of 30 Gy delivered over five fractions delivered daily.
- interventionNames
- Radiation: External Beam Radiotherapy
Primary outcomes (1)
- measure
- Post-operative Complication Rate
- timeFrame
- 120 days after surgery
- description
- Rate of post-operative complications.
Secondary outcomes (1)
- measure
- Local Recurrence Rate
- timeFrame
- 2 years and 5 years after surgical resection
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically confirmed soft tissue sarcoma of the extremity, trunk or retroperitoneum. 2. Has been offered preoperative radiation and surgery as part of standard-of-care treatment 3. Age ≥ 18 4. KPS ≥ 70 or ECOG 0 to 2 5. Life expectancy ≥ 6 months 6. If a woman is of childbearing potential, a negative serum or urine pregnancy test must be documented. 7. Ability to understand and the willingness to personally sign the written IRB approved informed consent document. Exclusion Criteria: 1. History of prior radiation to the area to be treated. 2. Active use of other anti-cancer investigational agents. 3. Planned use of concurrent chemotherapy, targeted therapy, or immunotherapy with radiation therapy (defined as the time interval starting 1 week before the first and last fraction of radiation therapy and surgery). 4. Pregnancy.
References
Publications (0)
Data not yet available
No reference posted for this study.