Actively Recruiting
The Total Neoadjuvant Therapy for Soft Tissue Sarcoma of the Extremities
Led by Fujian Medical University Union Hospital · Updated on 2024-09-19
51
Participants Needed
1
Research Sites
113 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
For localized soft tissue sarcomas (STS) of the extremities, limb-sparing or conservative surgery with perioperative radiotherapy (RT) is the standard of care. However, several challenges persist. Notably, there are exceedingly high rates of distant metastatic recurrence even after surgical resection and RT, and conventional fractionated radiotherapy has a prolonged duration (5-6 weeks). With advancements in RT technology, the gradual expansion of hypofractionated radiotherapy regimens enables significantly shorter treatment durations. Promising recent reports on 1-week hypofractionated RT regimens, such as the 5X5 Gy RT regimens, have demonstrated reasonable local control and acceptable toxicity in resectable STS.Addressing the challenge of distant metastasis, previous studies have indicated that AI regimens are expected to eliminate micrometastases and improve survival in patients with STS at a high risk of distant relapse. Therefore, the goal of this clinical trial is to investigate whether hypofractionated RT combined with a sequential chemotherapy（AI regimens）can enhance short-term treatment efficacy for extremity STS patients without compromising local control rates and increasing related toxicities
CONDITIONS
Official Title
The Total Neoadjuvant Therapy for Soft Tissue Sarcoma of the Extremities
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Primary soft tissue sarcoma of the extremities with high grade, tumor size 65 cm or deep tumor requiring neoadjuvant radiotherapy after multidisciplinary consultation
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- Age between 18 and 75 years old
- Histologic diagnosis of soft tissue sarcoma
- Ability to tolerate radiotherapy and AI chemotherapy regimen
- Normal function of major organs
You will not qualify if you...
- Presence of gross tumors after unplanned mass resection at another hospital
- Comorbidities preventing use of AI chemotherapy such as drug allergy, active bleeding, ulcers, intestinal perforation, obstruction, uncontrolled hypertension, severe heart failure, severe liver or kidney insufficiency
- New malignant tumors within 5 years except cervical carcinoma in situ or early cutaneous basal cell carcinoma
- Pathological types of non-pleomorphic rhabdomyosarcoma or Ewing sarcoma
- Soft tissue sarcoma curable by simple expansion
- Prior radiotherapy to the same site
- Presence of distant metastasis or lymph node metastasis
- Other severe medical conditions precluding surgery or study participation
- Previous exposure to chemotherapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fujian Medical University Union Hospital
Fuzhou, Fujian, China, 350001
Actively Recruiting
Research Team
Y
Yong Yang, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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