Extremity, Intensity-modulated Radiotherapy, Major Wound Complications, Sarcoma,Soft Tissue, Targetd Therapy, Trunk
Conditions
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.
Interventions
DRUGApatinib Mesylate
Apatinib Mesylate 500mg QD, begin from 2 weeks prior to IMRT, to 1 month after end of IMRT
Sponsors
Beijing Jishuitan Hospital
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of Major wound complications within 4 months post-surgery | 4-months post-surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| Local control | 2-year | — |
| Overall survival | 2-year | — |
| Pathological remission rate | 2 weeks after operation | Evaluate the tumor remission rate microscopically 2 weeks after operation |
Countries
China
Outcome results
None listed