Status:
RECRUITING
The Total Neoadjuvant Therapy for Soft Tissue Sarcoma of the Extremities
Lead Sponsor:
Fujian Medical University Union Hospital
Conditions:
Soft Tissue Sarcomas
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
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. Not...
Eligibility Criteria
Inclusion
- Primary soft tissue sarcoma of the extremities, with one of the following characteristics: high grade, ≥5cm or deep tumor, the need for neoadjuvant radiotherapy was determined after multidisciplinary consultation.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2.
- Age 18-75 years old.
- Histologic diagnosis of soft tissue sarcoma.
- Can tolerate radiotherapy and AI regimen treatment.
- The function of major organs is normal.
Exclusion
- There were no patients with gross tumors after unplanned mass resection in another hospital.
- Patients with other comorbidities cannot use AI chemotherapy: drug allergy, active bleeding, ulcers, intestinal perforation, intestinal obstruction, uncontrollable hypertension, grade III-IV cardiac insufficiency (NYHA standards), severe liver and renal insufficiency ( Level IV) etc.
- New malignant tumors within 5 years (except cervical carcinoma in situ or early cutaneous basal cell carcinoma).
- Pathological types: nonpleomorphic rhabdomyosarcoma, Ewing sarcoma.
- Soft tissue sarcoma curable by simple expansion.
- Previous history of radiotherapy to the same site.
- Combined with distant metastasis (M1) or lymph node metastasis (N1).
- Have other severe medical comorbidities that preclude surgery or participation in the study.
- Previous exposure to chemotherapy.
Key Trial Info
Start Date :
May 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT06593899
Start Date
May 1 2024
End Date
July 1 2026
Last Update
September 19 2024
Active Locations (1)
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1
Fujian Medical University Union Hospital
Fuzhou, Fujian, China, 350001