None listed
Conditions
Interventions
Drug : 1. Chemotherapy Group
In the chemotherapy group, participants with sarcoma in the extremities started their chemotherapy regimen within four weeks after undergoing surgery and completing the RT
meanwhile, those with retroperitoneal sarcoma started receiving adjuvant chemotherapy within 4–8 weeks after surgery.
Two different chemotherapy regimens were employed, and the appropriate regimen was
Sponsors
National Cancer Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients age 19–75 years 2. Patients who underwent complete resection of STS (extremity, trunk, or retroperitoneum) 3. Patients who underwent R0 resection (R0 resection through reoperation) 4. Patients with stage 3 STS (American Joint Committee on Cancer 8th ed.) 5. If STS develops in the extremities, patients who received =50 Gy of adjuvant radiotherapy before or after radical resection If the primary site of cancer is the extremities, only patients who completed radiotherapy are eligible. If the STS develops in the retroperitoneum, patients who underwent R0 resection without radiotherapy were considered eligible for analysis. 6. Patients with an Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0–1 7. Patients with adequate hematologic, organ, and coagulation functions within two weeks (14 days) prior to randomization: - Absolute neutrophil count (ANC) of =1.5 × 109/L. Granulocyte colony-stimulating factor were not administered within two weeks (14 days) prior to randomization. - Platelet count of =100 × 109/L - Hemoglobin level of =9.0 g/dL. Blood transfusion was not performed within two weeks (14 days) prior to randomization. - Creatinine clearance of =60 mL/min - Normal total bilirubin (for patients with Gilbert’s syndrome: total bilirubin of 40 mIU/mL 10. Women and men with childbearing potential who agreed to use highly effective birth control methods during the trial and until 3 months after the final administration of the study drug. Highly effective birth control methods were defined as contraceptive methods with a low failure rate (i.e., <1% per year) when used consistently and correctly, such as implants, injectables, combination oral contraceptives, some intrauterine devices, abstinence, and vasectomy. 11. Patients with a life expectancy of =3 months as deemed by the investigator 12. Patients who voluntarily signed the informed consent
Exclusion criteria
Exclusion criteria: 1. Patients who underwent R1–2 resection 2. Patients with bone sarcoma (osteosarcoma, Ewing’s sarcoma, chondrosarcoma, and extraskeletal myxoid chondrosarcoma) 3. Patients with alveolar soft part sarcoma, Kaposi’s sarcoma, desmoid tumor, gastrointestinal stromal tumor, and solitary fibrous tumor of pleural/peritoneal origin Head and neck STS (rare type of condition, and R0 resection often difficult) 4. Patients who previously received chemotherapy using doxorubicin, epirubicin, idarubicin, and/or other anthracyclines and ifosfamide 5. Patients who previously received mediastinal/pericardial radiotherapy or whole pelvic radiotherapy 6. Patients who were previously diagnosed with primary cancer other than the following types: a) Cured non-melanoma skin cancer b) Cured carcinoma in situ of the cervix c) Other types of solid tumors treated to achieve cure (with active disease unknown for 5 years prior to randomization) 7. Patients who preferred to undergo major surgery or require major surgery during the trial 8. Patients with progressive/active infection requiring antibiotic injection and symptomatic congestive heart failure (CHF) 9. Patients with uncontrolled comorbidities, including LVEF of 450 msec for men and >470 msec for women on screening electrocardiogram (ECG) with Bazett’s correction 12. Pregnant or breastfeeding women 13. Patients who used investigational product within 28 days prior to randomization, who participated in another clinical trial that involved the unapproved use drugs or equipment, or who discontinued the use of study drug in such clinical trial 14. Patients with active fungal, bacterial, and/or known viral infection, including human immunodeficiency virus (HIV) or viral hepatitis (A, B, or C) 15. Patients who were infected with coronavirus disease 2019 in the past two weeks or recently developed its symptoms 16. Patients with known alcohol or drug abuse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year RFS on observation group | — |
Secondary
| Measure | Time frame |
|---|---|
| survival rate, median, and 95% confidence interval, afety evaluation(CTCAE 5.0) | — |
Countries
Korea, Republic of
Contacts
Public ContactHyunjung Park
National Cancer Center
Outcome results
None listed