Soft tissue sarcoma
Conditions
Interventions
Radiotherapy alone:Moderately fractionated preoperative radiotherapy
Fluroparib:Moderately fractionated preoperative radiotherapy and Fluroparib
Sponsors
Department of Radiotherapy, Cancer Hospital and Institute, National Cancer Center, Chinese Academy of Medical Sciences & Peking Union Medical Center, Beijing, China
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1.Age older than 18 years. 2.Histology proven soft tissue sarcoma of truncal or extremity, deemed appropriate for preoperative radiotherapy and conservative surgery by multidisciplinary discussion. 3.ECOG 0-3 4.Histology reviewed by reference pathologist 5.Lesion can be assessed 6.Can tolerate radiotherapy and Fluzoparib 7. Patients exhibited adequate bone marrow and hepatic function (For RT alone group: white blood cell count =2.5 × 10? cells per L, platelet count =75 × 10? cells per L, total bilirubin =2 times upper limit of normal, and ALT=4 times upper limit of normal, For Fluzoparib group:white blood cell count =3.5 × 10? cells per L, platelet count =90 × 10? cells per L, total bilirubin =2 times upper limit of normal, and ALT=4 times upper limit of normal). Glomerular filtration rate was =50ml/min(Cockcroft-Gault formula). 7.Agree contraception. 8.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
Exclusion criteria: 1. No gross tumor post-resection in other center. 2. Contraindications to Fluzoparib, including allergic to Fluzoparib, 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. 3. Dermatofibrosarcoma protuberans(DFSP), Desmoids, etc. 4. Benign histology 5. Secondary cancer within 5 years (except cervical carcinoma in situ or early-stage skin basal cell carcinoma) 6. STS can be cured by extensive operation alone. 7. Previous irradiation to the same area 8. radiological evidence of distant metastases 9. Other contraindications, can’t tolerate operation or other treatment needed in this study. 10. Patients anticipated to receive neoadjuvant chemotherapy or other systematic intervention 4 weeks prior to enrollment was excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major wound complications 4 months post-surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| Local Control;Acute and Late Toxicities;Limb Function and Quality of Life;Overall Survival;Pathological complete remission rate; | — |
Countries
China
Contacts
Public ContactNingning Lu
Department of Radiotherapy, Cancer Hospital and Institute, National Cancer Center, Chinese Academy of Medical Sciences & Peking Union Medical Center, Beijing, China
Outcome results
None listed