Clinical trial · Interventional
Wide Excision of Soft Tissue Sarcomas in Combination With Interstitial Radiation Therapy
Wide Excision of Soft Tissue Sarcomas in Combination With Interstitial Radiation Therapy in Patients With Soft Tissue Sarcomas of the Upper and Lower Extremities Compared With Postoperative Radiation Therapy
- 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)
Intraoperatively, in the bed of the removed tumor, a surgical mesh is sutured onto which the intrastats are fixed. On days 2-3, topometric preparation is carried out, the choice of the amount of irradiation, the calculation of the program. On the 4-5th day after the operation, a course of intra-tissue radiation therapy begins in a single dose of 3 to 5 Gy in 10 fractions 2 times a day with an interval between fractions of 6 hours, the planned total dose is from 30 to 50 Gy. (from 40 to 70 IGy). Follow-up examination after 4 weeks and then every 3 months for 24 months
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
| Soft Tissue Sarcoma | Soft Tissue Sarcoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Interstitial radiation therapy | Radiation | — | UNRESOLVED |
| Postoperative external beam therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Interstitial radiation therapy
- description
- Duration: 11 days
- interventionNames
- Radiation: Interstitial radiation therapy
- type
- ACTIVE_COMPARATOR
- label
- Postoperative external beam therapy, on the bed of the removed tumor
- description
- Duration: 4 weeks
- interventionNames
- Radiation: Postoperative external beam therapy
Primary outcomes (1)
- measure
- disease-free survival
- timeFrame
- 24 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * C49.1 Malignant neoplasm of the connective and soft tissues of the upper limb, including the shoulder girdle * C49.2 Malignant neoplasm of the connective and soft tissues of the lower limb, including the hip region * Tumor size 7 cm or less * For malignant tumors: Grade 2-3 * Locally advanced soft tissue sarcomas * Absence of regional metastases * Tumor recurrence Exclusion Criteria: * Children, women during pregnancy, childbirth, women during breastfeeding. * Military personnel, with the exception of contract military personnel. * Persons with mental disorders. * Persons detained, taken into custody, serving a sentence in the form of restriction of freedom, arrest, imprisonment or administrative arrest. * The age of patients is under 18 years old * Histologically confirmed diagnosis of GIST, Kaposi's sarcoma, alveolar, clear cell sarcoma, chondrosarcoma, paraossal osteosarcoma * Inoperable tumor * A tumor with decay or with the threat of decay * The presence of damage to the skin in the affected area * The presence of a second malignant tumor * Having an active or chronic fungal / bacterial / viral infection * Uncontrolled chronic diseases of the liver, kidneys in the acute stage * Superficial tumor (within the skin) * The use of a reconstructive plastic component using a displaced musculocutaneous flap * The use of vascular prosthetics * The removed tumor bed is more than 7 cm * The presence of a tumor growing into the bone * The presence of blood vessels and nerves in the removed tumor bed * Presence of metastases * Surgical intervention using transplanted skin
References
Publications (0)
Data not yet available