Comparing two types of radiation therapy for soft tissue sarcoma
Spatially Fractionated Radiotherapy Versus Conventional Radiotherapy in the Treatment of Soft Tissue Sarcoma:A Multicenter，Prospective, Phase II, Randomized Controlled Trial
NA · Shandong Cancer Hospital and Institute · NCT06980259
This study is testing whether a new type of radiation therapy can work better than the standard treatment for people with soft tissue sarcoma that has a tumor size of at least 5 cm.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 106 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Shandong Cancer Hospital and Institute (other) |
| Drugs / interventions | Radiation |
| Locations | 1 site (Jinan, Shandong) |
| Trial ID | NCT06980259 on ClinicalTrials.gov |
What this trial studies
This multicenter, prospective, randomized controlled clinical trial evaluates the efficacy and safety of Spatially Fractionated Radiation Therapy (SFRT) compared to Conventional Radiation Therapy (CRT) in treating soft tissue sarcoma (STS) with a minimum tumor diameter of 5 cm. A total of 106 patients will be enrolled and randomized into two groups, receiving either SFRT or CRT. The primary endpoint is the objective response rate of the target lesion at various time points post-treatment, while secondary endpoints include local control rate, progression-free survival, safety, and quality of life assessments. The study utilizes advanced radiation techniques to enhance tumor control and potentially stimulate immune responses.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-70 with a confirmed diagnosis of soft tissue sarcoma and a tumor diameter of at least 5 cm.
Not a fit: Patients with secondary primary malignancies, severe organ dysfunction, or those unsuitable for radiotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for patients with soft tissue sarcoma, potentially improving response rates and quality of life.
How similar studies have performed: While the approach of spatially fractionated radiotherapy is innovative, similar studies have shown promise in enhancing treatment outcomes for difficult-to-treat tumors.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * (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.
Where this trial is running
Jinan, Shandong
- Shandong Cancer Hospital and Institute — Jinan, Shandong, China (RECRUITING)
Study contacts
- Principal investigator: Jinbo Yue, Doctor — Shandong Cancer Hospital and Institute
- Study coordinator: Jinbo Yue, Doctor
- Email: jbyue@sdfmu.edu.cn
- Phone: 0531-67626442
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Soft Tissue Sarcoma, Spatially Fractionated Radiotherapy, Objective Response Rate, Conventional Radiotherapy