CTRI/2022/10/046672尚未招募3 期
Randomized, Open-label, Phase III trial of Adjuvant Chemotherapy Versus Observation in Non-metastatic, High risk, Soft Tissue Sarcomas (ACO-Sarc trial).
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Patients must satisfy all the following criteria to be eligible for the study
- •1. Adult patients of either sex above or equal to 18 years of age.
- •2. Willing to provide written informed consent.
- •3. Histopathologically proven soft tissue sarcoma of extremity, limb girdle or truncal wall
- •location undergoing curative resection either primary or recurrent cases.
- •4. Patients must be chemotherapy naïve.
- •5. Satisfactory wound healing to give chemotherapy.
- •6. Absence of infection
- •7. ECOG performance status 0, 1, or 2 at the time of study inclusion.
- •8. STS belonging to one of the six specific histologic subtypes:
- •i) Undifferentiated pleomorphic sarcoma,
- •ii) Synovial sarcoma,
- •iii) Myxoid liposarcoma,
- •iv) Leiomyosarcoma, and
- •v) Malignant peripheral nerve sheath tumour
- •9. Patients with High risk of relapse with an estimated 10-year pr-OS of less than 60 %
- •using online Sarculator. ((http://www.sarculator.com)
- •10. Presence of adequate contraception in fertile patients and/or agreement on patientâ??s
- •part after counselling to use adequate methods of contraception.
- •11. Women of childbearing potential must have a negative serum or urine pregnancy test at
- •12. Adequate haematological function (defined as an absolute neutrophil count >=1•5 Ã? 109
- •cells per L, platelet count >=100 Ã? 109 platelets per L, and hemoglobin >=8 g/dL [may have
- •been transfused]).
- •13. Adequate liver function (defined as a total bilirubin concentration of 2 Ã? the upper limit
- •of normal [ULN] range and aspartate aminotransferase and alanine aminotransferase
- •concentrations of <=2•5 Ã? ULN) and
- •14. Adequate renal function (defined as an estimated creatinine clearance >50 ml/min
- •according to the Cockcroft-Gault formula) functions at the time of study inclusion.
排除标准
- •Patients who meet any of below criteria will be excluded from the study:
- •1. Patients who have a metastatic disease
- •2. STS arising from locations other than extremity, limb girdle or truncal wall viz retro
- •peritoneum and head and neck location.
- •3. STS of any other histological subtype other than Undifferentiated pleomorphic sarcoma,
- •Synovial sarcoma, Myxoidliposarcoma, Liposarcoma, Leiomyosarcoma, or Malignant
- •peripheral nerve sheath tumour
- •4. Patients with uncontrolled coronary artery disease
- •5. Patients with known hypersensitivity or contraindications to any study-related
- •medication.
- •6. Patients with a previous or current diagnosis of Human Immunodeficiency Virus (HIV)
- •7. Pregnant or breast-feeding women.
- •8. Patients with progressive active infection or any other severe medical condition that
- •could hamper adequate treatment administration.
研究者
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