Status:
RECRUITING
Spatially Fractionated Radiotherapy Versus Conventional Radiotherapy in the Treatment of Soft Tissue Sarcoma
Lead Sponsor:
Shandong Cancer Hospital and Institute
Conditions:
Soft Tissue Sarcoma (STS)
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
This study is a multicenter, prospective, randomized controlled phase II clinical trial designed to evaluate the efficacy and safety of Spatially Fractionated Radiation Therapy (SFRT) compared to Conv...
Detailed Description
This study is a multicenter, prospective, randomized controlled phase II clinical trial designed to systematically compare the efficacy and safety of Spatially Fractionated Radiation Therapy (SFRT) ve...
Eligibility Criteria
Inclusion
- 1\. Age 18-70 years, irrespective of gender. 2. Pathologically or clinically confirmed diagnosis of soft tissue sarcoma. 3. Minimum tumor diameter ≥5 cm. 4. Receiving systemic treatment as per multidisciplinary team (MDT) recommendations.
- 5\. Measurable lesion (per RECIST 1.1/Choi criteria: longest diameter \>1.5 cm, or \>1 cm with two measurable perpendicular diameters).
- 6\. ECOG performance status ≤2. 7. Expected survival ≥3 months. 8. Normal liver, kidney, lung, and cardiac function, with tolerance for treatment.
- 9\. Patients of childbearing potential agree to use reliable contraception during treatment and for one year thereafter.
- 10\. Voluntary provision of signed informed consent.
Exclusion
- (1) Patients with a second primary malignancy. (2) Diagnosis of aggressive fibromatosis or rhabdomyosarcoma. (3) Prior radiotherapy to the target lesion. (4) Tumor unsuitable for radiotherapy. (5) Severe liver, kidney, lung, or cardiac dysfunction, precluding tolerance to systemic therapy or radiotherapy.
- (6) Other severe medical conditions that may impact the study (e.g., uncontrolled diabetes, gastric ulcers, or other serious cardiopulmonary diseases).
- (7) Severe or uncontrolled infections, or active autoimmune diseases. (8) Clinically evident central nervous system dysfunction. (9) Pregnant or lactating women, or women of childbearing potential not using contraception.
- (10) Other conditions deemed unsuitable for participation by the investigator.
Key Trial Info
Start Date :
May 20 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 20 2028
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT06980259
Start Date
May 20 2025
End Date
May 20 2028
Last Update
May 30 2025
Active Locations (1)
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1
Shandong Cancer Hospital and Institute
Jinan, Shandong, China, 0531