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Preoperative intensity-modulated radiotherapy (IMRT) with concurrent Anlotinib Hydrochloride for locally extremity or trunk sarcoma

Phase II prospective trial of preoperative intensity-modulated radiotherapy (IMRT) with concurrent Anlotinib Hydrochloride for truncal/extremity soft tissue sarcoma

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000033377
Enrollment
Unknown
Registered
2020-05-30
Start date
2020-06-01
Completion date
Unknown
Last updated
2020-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

soft tissue sarcoma

Interventions

Single-arm:Preoperative RT with concurrent Anlotinib

Sponsors

Cancer Hospital of Chinese Academy of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Patients with primary or recurrent soft tissue sarcomas of limbs or trunk (excluding those who need extended resection after unscheduled tumor resection in other hospitals) need to receive radiotherapy after multidisciplinary ward round discussion; 2. Patients aged 18-75 years; 3. Patients with ECoG 0-3 points; 4. Patients with soft tissue sarcomas confirmed by pathology; 5. Patients with assessable lesions; 6. Patients who can tolerate radiotherapy and enrotinib; 7. The female patients or the male patients whose sexual partners are women of childbearing age should take effective contraceptive measures during the whole treatment period and 6 months after the last medication; 8. Patients who can sign informed consent and have follow-up conditions.

Exclusion criteria

Exclusion criteria: 1. Patients who have no gross tumor after unplanned tumor resection; 2. Patients with other complications can not use arotinib: arotinib allergy, active bleeding, ulcer, intestinal perforation, intestinal obstruction, uncontrollable hypertension, grade III- IV cardiac insufficiency (NYHA standard), severe hepatorenal insufficiency (grade IV), etc; 3. Fibrosarcoma of skin protuberant type, patients with sclerofibromatosis; 4. Patients with benign tumors; 5.5-year-old patients with new cancer (except cervical carcinoma in situ or early skin basal cell carcinoma); 6. Patients with soft tissue sarcomas that can be cured by simple dilatation; 7. Patients with previous radiotherapy history of the same site; 8. Patients with distant metastasis (M1); 9. Patients with other serious medical complications who are unable to operate or participate in the study; 10. Patients who have received or intend to receive neoadjuvant chemotherapy.

Design outcomes

Primary

MeasureTime frame
Major Wound Complications;

Secondary

MeasureTime frame
Acute toxicities;Late toxicities;extremity function;Quality of Life;2-year local control;2-year overall survival;

Countries

China

Contacts

Public ContactNingning Lu, Shengji Yu, Shulian Wang

Department of Radiotherapy, Cancer Hospital, Chinese Academy of Medical Sciences

ningninglu09@163.com+86 10-87787639

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026