Clinical trial · Interventional
Role of Barrier Resection in Local Control for Extremity Recurrent Soft Tissue Sarcomas
Phase III Study of The Role of Barrier Resection in Local Control in Treatment of Extremity Soft Tissue Sarcomas
- 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 randomized, controlled trial is aiming at comparing local control rate between two surgical resections, barrier resection and local wide resection with 1cm or equivalent normal tissues. This is based on the fact that the goal of local surgical treatment is to remove the tumor with negative margin and best functional outcome, but there is a lack of standard principle of surgery. Some surgical oncologists recommended enlarging surgical field in which case the associated muscle was removed from origin to insertion, the previous surgical scar and radiation field were also grossly remove, though there would be extra trauma and unacceptable function impairment, they believe that patients would benefit from "big operations". Most other surgeons would perform a sarcoma resection through normal tissues, and reported a fair local control as long as a negative margin was obtained. As reported by various authors, recurrent STSs are associated with higher risk to develop further recurrence as compared to primary STSs, thus, efforts should focus on this category of STSs to improve outcome.
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 |
|---|---|---|---|
| Local Recurrence of Malignant Tumor of Soft Tissue | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| barrier resection/1cm resection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Barrier resection
- description
- Barrier resection was defined as "en bloc" removal of tumor with surrounding barriers. The barriers include muscular fascia, vascular adventitia, epineurium and periosteum, in some cases where there is no barrier, 3-5cm of healthy tissue is considered equivalent. Barrier resection was developed according to the above characteristics of STSs, which featured with the fact that sarcomas take the path of least resistance and initially grow within the anatomical compartment in which they arose, and the phenomenon that skip metastases are limited within the same anatomic compartment in which the primary lesion is located.Further surgery would be 1cm resection if a recurrence occurs.
- interventionNames
- Procedure: barrier resection/1cm resection
- type
- ACTIVE_COMPARATOR
- label
- 1 cm resection
- description
- Surgical margin width is determined mainly by the distance from the tumor edge to the periphery of the specimen, different margin width of 1-5cm has been recommended for obtaining a safe margin,but the local recurrence rate remains to be 10-25%. Further surgery would be barrier resection if a recurrence occurs.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 14 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Confirmed recurrent ESTS. 2. Confirmed imaging targets, resectable, no metastasis. 3. No radiochemotherapy in the past 3 months. 4. ECOG status of 0-1. 5. Age between 14 and 80. 6. WBC over 3000/µL，Neutriphil ≥1,500/µL, PLT ≥100,000/µL. 7. Understand the and sign the consent form with compliance. Exclusion Criteria: 1. Pregnant or lactating. 2. Metastasis. 3. Radiotherapy or chemotherapy in the past 3 months. 4. Another malignancy in the past 3 years. 5. Uncontrollable heart disease or psychologically unstable. 6. Severe infection. 7. In recovery of last operation. 8. Preoperative MSTS score less than 15. 9. Other dysfunctions or situations which assessed to be unsuitable for the trial.
References
Publications (0)
Data not yet available