KCT0008321
Not yet recruiting
未知
Randomized Phase 2 study of Adjuvant Chemotherapy vs Observation After Complete Resection of Stage III Soft Tissue Sarcomas
ational Cancer Center0 sites98 target enrollmentTBD
ConditionsNeoplasms
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Neoplasms
- Sponsor
- ational Cancer Center
- Enrollment
- 98
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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.
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)
Outcomes
Primary Outcomes
Not specified
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