Clinical trial NCT05167994: Preoperative IMRT With Concurrent Anlotinib for Localised Extremity or Trunk Sarcoma
Official title: Preoperative Intensity-modulated Radiotherapy (IMRT) With Concurrent Anlotinib Hydrochloride for Localised Extremity or Trunk Sarcoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Sarcoma,Soft Tissue
Extremity
Trunk
Anlotinib
Intensity-modulated Radiotherapy
Major Wound Complications
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
First posted: 2021-12-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To investigate the safety and efficacy of preoperative IMRT and concurrent Anlotinib Hydrochloride 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 Anlotinib Hydrochloride for primary truncal or extremity soft tissue sarcoma; To assess the relationship between the MRI imaging, pathological findings and local control.


Eligibility criteria: 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 Anlotinib
* 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 Anlotinib, including allergic to Anlotinb, 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.

Primary outcomes:
measure: Major wound complications
timeFrame: 4-months post-surgery
Secondary outcomes:
measure: Acute and late toxicities
timeFrame: acute toxicities were evaluated during and 3 months after IMRT, late toxicities were evaluted after 6 months
measure: Quality of Life
timeFrame: pre-IMRT, end of IMRT, 1 months post-IMRT, and every 3 to 6 months during follow-up
measure: Extremity function
timeFrame: pre-IMRT, end of IMRT, 1 months post-IMRT, and every 3 to 6 months during follow-up
measure: Pathological remission rate
timeFrame: 2 weeks after operation
measure: Local control
timeFrame: 2-year
measure: Overall Survival
timeFrame: 2-year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Radiotherapy Department of Cancer Hospital, Chinese Academy of Medical Sciences
state: Beijing
Study officials:
References: