Preoperative intensity-modulated radiotherapy with concurrent anlotinib for localized extremity and trunk soft tissue sarcoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 2 interventional trial giving anlotinib hydrochloride concurrently with preoperative intensity-modulated radiotherapy (IMRT) for primary truncal or extremity soft tissue sarcoma. The protocol tracks safety, tumor response, local control, quality of life, and limb function after the combined treatment. Investigators will also explore whether anlotinib enhances radiosensitivity and correlate MRI imaging features with pathology and local control. The trial is conducted at the Cancer Hospital, Chinese Academy of Medical Sciences in Beijing and enrolls adult patients judged suitable for preoperative radiotherapy and limb-conserving surgery.

Why it matters

Who can join: the full rules

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.

Where it's running

• Radiotherapy Department of Cancer Hospital, Chinese Academy of Medical Sciences
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Ning-Ning Lu
• Email: Ning-Ning.Lu@hotmail.com
• Phone: +868611804268

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.