NCT05235100CompletedPhase 2
Preoperative Intensity-modulated Radiotherapy (IMRT) With Concurrent Apatinib Mesylate for Localised Extremity or Trunk Sarcoma
Cancer Institute and Hospital, Chinese Academy of Medical Sciences1 site in 1 country30 target enrollmentStarted: September 1, 2021Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Rate of Major wound complications within 4 months post-surgery
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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.
- •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.
Arms & Interventions
Apatinib arm
Experimental
Apatinib 500mg QD, used 2 weeks prior to IMRT, concurrent with pre-operative IMRT, and 1 month after end of IMRT
Intervention: Apatinib Mesylate (Drug)
Outcomes
Primary Outcomes
Rate of Major wound complications within 4 months post-surgery
Time Frame: 4-months post-surgery
Secondary Outcomes
- 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)
- 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)
- 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)
- Pathological remission rate(2 weeks after operation)
- Overall survival(2-year)
Investigators
NINGNING LU
Principle Investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study Sites (1)
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