Spatially Fractionated Radiotherapy and Conventional Radiotherapy for Soft Tissue Sarcoma
Spatially Fractionated Radiotherapy
+ Conventional Radiotherapy
Neoplasms+1
+ Neoplasms by Histologic Type
+ Sarcoma
Treatment Study
Summary
Study start date: May 20, 2025
Actual date on which the first participant was enrolled.This study aims to compare two types of radiation therapy for treating soft tissue sarcoma, a type of cancer that forms in the soft tissues of the body. Spatially Fractionated Radiation Therapy (SFRT) and Conventional Radiation Therapy (CRT) are being tested to see which is more effective and safe for patients with tumors larger than 5 cm. Soft tissue sarcoma is known to be less responsive to traditional radiation, so this study could help find better ways to control the tumor and improve patients' outcomes. The study is important because it might lead to improved treatment strategies for this type of cancer and possibly other cancers that are hard to treat with radiation. In the study, a total of 106 patients will be randomly assigned to receive either SFRT or CRT. SFRT involves giving radiation in a more targeted way, with additional high-dose treatments, while CRT uses a standard approach. The effectiveness of the treatments will be assessed by looking at how well the tumors respond over 12 months, and other factors like how long patients live without their cancer getting worse. Safety is also an important part of the study, with regular checks for side effects during and after treatment. The results will help determine if SFRT can offer better outcomes than CRT, which would be a significant advancement in treating this cancer.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.106 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 70 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Shandong Cancer Hospital and Institute
Jinan, ChinaOpen Shandong Cancer Hospital and Institute in Google Maps