Randomized Phase 2 study of Adjuvant Chemotherapy vs Observation After Complete Resection of Stage III Soft Tissue Sarcomas
- Conditions
- Neoplasms
- Registration Number
- KCT0008321
- Lead Sponsor
- ational Cancer Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 98
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 <3 mg/dL)
- Alanine aminotransferase/aspartate aminotransferase (AST/ALT) level of =3.0 × upper limit of normal (ULN); if the tumor developed in the liver, those with an AST/ALT level of =5.0 × ULN were eligible.
- International normalized ratio (INR) or prothrombin time of =1.5 × ULN, and normal coagulation based on a partial thromboplastin time (PTT) or activated partial thromboplastin time (aPTT) of =1.5 × ULN
8. Patients with a left ventricular ejection fraction (LVEF) of =50% within 28 days prior to randomization
9. Women of childbearing age with a negative serum pregnancy test within 7 days prior to randomization
- Exclusion: women with surgery-related infertility (6 weeks or more after undergoing bilateral oophorectomy, or may or may not undergo hysterectomy or tubal ligation) or who are unable to conceive due to menopause
Post-menopausal women” were defined as women who meet one of the following criteria:
- Women who experienced spontaneous amenorrhea for 12 months or longer without being induced by medical conditions such as anorexia nervosa, or medication that causes amenorrhea (e.g., oral contraceptives, hormones, gonadotropin-releasing hormone, anti-estrogens, selective estrogen receptor modulators, or chemotherapy)
- Women who experienced spontaneous amenorrhea for 12 months or longer and with a follicle-stimulating hormone (FSH) level 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
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 <50%, severe myocardial failure, arrhythmias, and myocardiopathy
10. Patients who were diagnosed with unstable angina or myocardial infarction or with a history of angioplasty or cardiac stent insertion within six months prior to randomization
11. Patients with QTcB interval 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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 2-year RFS on observation group
- Secondary Outcome Measures
Name Time Method survival rate, median, and 95% confidence interval, afety evaluation(CTCAE 5.0)