Preoperative IMRT With Concurrent Anlotinib for Localised Extremity or Trunk Sarcoma
NCT ID: NCT05167994
Last Updated: 2021-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
30 participants
INTERVENTIONAL
2020-05-01
2023-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Anlotinib arm
Pre-operative IMRT with concurrent and sequential Anlotinib
Anlotinib hydrochloride
Anlotinib 12mgQD, from D1 of pre-operative IMRT to 1 month after end of IMRT
Interventions
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Anlotinib hydrochloride
Anlotinib 12mgQD, from D1 of pre-operative IMRT to 1 month after end of IMRT
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Chinese Academy of Medical Sciences
OTHER
Responsible Party
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Ning-Ning Lu
Principle Investigator
Locations
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Radiotherapy Department of Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Ningning Lu, Doctor
Role: primary
Shu-Lian Wang, M.D.
Role: backup
Other Identifiers
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NCC2333
Identifier Type: -
Identifier Source: org_study_id