Safety and Efficacy of Preoperative SBRT and Radical Surgery for Soft Tissue Sarcoma of Extremities
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: stereotactic body raiotherapy.
- Who it may be relevant to
- Registry conditions: Soft Tissue Sarcoma, Stereotactic Body Radiotherapy, Surgery. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Safety and Efficacy of Preoperative Stereotactic Body Radiotherapy (SBRT) and Radical Surgery for Soft Tissue Sarcoma of Extremities
Overview
Currently, the effectiveness and safety of preoperative hypo-fractionated radiotherapy in treating extremity soft tissue sarcomas remain inconclusive, warranting further investigation. Optimizing the neoadjuvant radiotherapy approach, including fractionation schedules and the interval between radiotherapy and surgery, is crucial to enhancing clinical efficacy while ensuring safety. This study proposes a multicenter, prospective, single-arm clinical trial utilizing preoperative SBRT for patients with high-grade extremity STS, tumors larger than 5 cm, or cases where achieving safe surgical margins is challenging due to involvement of surrounding blood vessels or nerves. The trial aims to preliminarily assess the impact of preoperative SBRT followed by radical surgery on surgical safety, quality of life, and tumor control in these patients.
Detailed description
The effectiveness and safety of preoperative hypo-fractionated radiotherapy in treating extremity soft tissue sarcomas remain inconclusive, warranting further investigation. Optimizing the neoadjuvant radiotherapy approach, including fractionation schedules and the interval between radiotherapy and surgery, is crucial to enhancing clinical efficacy while ensuring safety. This study proposes a multicenter, prospective, single-arm clinical trial utilizing preoperative SBRT for patients with high-grade extremity STS, tumors larger than 5 cm, or cases where achieving safe surgical margins is challenging due to involvement of surrounding blood vessels or nerves. The trial aims to preliminarily assess the impact of preoperative SBRT followed by radical surgery on surgical safety, quality of life, and tumor control in these patients.
Interventions
- Radiation stereotactic body raiotherapy
Neoadjuvant stereotactic body radiation therapy followed by radical surgery for soft tissue sarcoma.
Primary outcome measures
- Safety and tolerability of radiotherapy followed by radical surgery [Time frame: 120 days after radical surgery]
Secondary outcome measures (4)
- Extremity function and Quality of life by EORTC QLQ-C30 [Time frame: Assessed up to 12 months]
- Recurrence free survival [Time frame: 1-,2-,3-year after radical surgery]
- Progression free survival [Time frame: 1-,2-,3-year after radical surgery]
- Overall survival [Time frame: 1-,2-,3-year after radical surgery]
Eligibility criteria
Inclusion criteria
- Aged ≥18 years;
- Confirmed diagnosis of soft tissue sarcomas;
- Highly malignant soft tissue sarcomas;
- Not received surgery, chemotherapy or other antitumor therapy;
- ECOG (Eastern Cooperative Oncology Group) performance status 0 or 1;
- Signed informed consent;
- Willing to provide tissue from an excisional biopsy of a tumor lesion，willing to provide blood sample before and after treatment;
Exclusion criteria
- Patients with soft tissue sarcoma of extremities with shallow tumor location, small size, low grade pathology and operable surgical resection;
- Distant metastasis;
- Received surgery or chemotherapy or other antitumor therapy;
- Previously participated in other clinical trials;
- History of severe allergies, patients with allergic conditions, such as contrast agent allergy;
- Known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy, or in situ cervical cancer.
- Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy;
- Active infection requiring systemic therapy;
- Known psychiatric or substance abuse disorders ;
- Pregnant or breastfeeding;
- Known history of human immunodeficiency virus (HIV: HIV 1/2 antibodies);
- Received a live vaccine within 30 days before radiotherapy.
- Unable to lie flat.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- the second affiliated hospital of Zhejiang University Hangzhou, Zhejiang, China, 310009 — Hangzhou
Identifiers
NCT: NCT06760221 · 2023-0177