Preoperative IMRT With Concurrent Apatinib for Localised Extremity or Trunk Sarcoma
- Conditions
- Sarcoma,Soft TissueExtremityTrunkIntensity-modulated RadiotherapyMajor Wound ComplicationsTargetd Therapy
- Interventions
- Registration Number
- NCT05235100
- Lead Sponsor
- Chinese Academy of Medical Sciences
- Brief Summary
To investigate the safety and efficacy of preoperative IMRT and concurrent Apatinib for primary truncal or extremity soft tissue sarcoma; To investigate the Quality of life and extremity function post-combination treatment; To study the mechanism of radio-sensitizing effects of Apatinib for primary truncal or extremity soft tissue sarcoma; To assess the relationship between the MRI imaging, pathological findings and local control.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
- Age older than 18-yo.
- Histology proven soft tissue sarcoma of truncal or extremity, deemed appropriate for preoperative radiotherapy and conservative surgery by multidisciplinary discussion.
- ECOG 0-3
- Histology reviewed by reference pathologist
- Lesion can be assessed
- Can tolerate radiotherapy and Apatinib
- Agree contraception.
- Informed consent: All patients must sign a document of informed consent indicating their understanding of the investigational nature and risks of the study before any protocol related studies are performed
- No gross tumor post-resection in other center.
- Contraindications to Apatinib, including allergic to Apatinib, active bleeding, ulcer, enteric perforation, enteric obstruction, uncontrolled hypertension, Grade 3 to 4 cardiac insufficiency (per NYHA criteria), and severe hepatic or renal insufficiency (Grade 4), etc.
- Dermatofibrosarcoma protuberans(DFSP), Desmoids, etc.
- Benign histology
- Secondary cancer within 5 years (except cervical carcinoma in situ or early-stage skin basal cell carcinoma)
- STS can be cured by extensive operation alone.
- Previous irradiation to the same area
- radiological evidence of distant metastases
- Other contraindications, can't tolerate operation or other treatment needed in this study.
- Neoadjuvant chemotherapy given or planned.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Apatinib arm Apatinib Mesylate Apatinib 500mg QD, used 2 weeks prior to IMRT, concurrent with pre-operative IMRT, and 1 month after end of IMRT
- Primary Outcome Measures
Name Time Method Rate of Major wound complications within 4 months post-surgery 4-months post-surgery
- Secondary Outcome Measures
Name Time Method Extremity function scores From date of enrollment to 2 years after surgery, specifically at pre-IMRT, end of IMRT, 1 months post-IMRT, and every 3 to 6 months during follow-up up to 2 years post-surgery Evaluate the extremity function by MSTS (Musculoskeletal Tumor Rating Scale) and TESS (Toronto Extremity Salvage Score) forms at different time points
Local control 2-year Acute and late toxicities acute toxicities were evaluated during and 3 months after IMRT, late toxicities were evaluted after 6 months Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Patient-reported Quality of Life assessed by EORTC-QLQ-C30 questionnaire From date of enrollment to 2 years after surgery, specifically at pre-IMRT, end of IMRT, 1 months post-IMRT, and every 3 to 6 months during follow-up up to 2 years post-surgery Evaluate the quality of life by patient-reported EORTC-QLQ-C30 questionnaire at different time points
Pathological remission rate 2 weeks after operation Evaluate the tumor remission rate microscopically 2 weeks after operation
Overall survival 2-year
Trial Locations
- Locations (1)
Radiotherapy Department of Cancer Hospital, Chinese Academy of Medical Sciences
🇨🇳Beijing, Beijing, China