Surgical removal of soft tissue sarcomas with 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

This study is testing if removing soft tissue sarcomas and then using radiation therapy helps patients heal better and improves their treatment results.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 78 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Blokhin's Russian Cancer Research Center (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Moscow)
• Trial ID: NCT05057195 on ClinicalTrials.gov

What this trial studies

This clinical trial involves the surgical removal of soft tissue sarcomas followed by interstitial radiation therapy. After the tumor is excised, a surgical mesh is placed in the tumor bed, and radiation therapy is administered in multiple fractions over several days. The study includes pre-operative blood tests and post-operative assessments to monitor healing and treatment efficacy. Patients will be followed up for 24 months to evaluate outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults with locally advanced soft tissue sarcomas measuring 7 cm or less, without regional metastases.

Not a fit: Patients with inoperable tumors, certain specific sarcoma types, or those under 18 years old will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve local control of soft tissue sarcomas and enhance patient survival rates.

How similar studies have performed: Other studies have shown promise with similar interstitial radiation therapy approaches, indicating potential for success in this trial.

Eligibility criteria

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

Where this trial is running

Moscow

• Federal State Budgetary Institution "N.N. Blokhin National Medical Research Center of Oncology" оf the Ministry of Health of the Russian Federation — Moscow, Russian Federation (Recruiting)

Study contacts

• Principal investigator: Aslan Valiev, PhD — N.N. Blokhin NMRCO
• Study coordinator: Denis Burov, PhD

Conditions Sarcoma; Soft Tissue Sarcoma