A Multicenter Phase II Clinical Trial of Neoadjuvant Trabectedin (Yondelis) in Patients With Localized Myxoid / Round Cell Liposarcoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 29
- 主要终点
- Percentage of Participants With Pathological Complete Response (pCR)
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of trabectedin for the treatment of localized (non-metastatic) myxoid / round cell liposarcoma (malignant tumor derived from primitive or embryonal lipoblastic cells).
详细描述
This is an open-label (all people know the identity of the intervention), prospective (study following participants forward in time), multicenter (when more than one hospital or medical school team work on a medical research study) study of trabectedin for the treatment of localized myxoid / round cell liposarcoma (MRCL). Trabectedin will be given at 1.5 milligram per meter square (mg/m^2) over a 24-hour intravenous (iv) infusion every 3 weeks for a minimum of 3 and a maximum of 6 cycles along with dexamethasone 20 mg iv which will be given within 30 minutes before start of each trabectedin iv infusion. Participants whose myxoid/round cell liposarcoma (MRCL) do not progress at the end of the neoadjuvant treatment will be followed every 6 weeks for disease progression or until 6 months post definitive surgery, in the absence of unacceptable toxicity and/or disease progression. Efficacy will be assessed by determining the pathologic Complete Response (pCR) rate assessed in the tumor surgical specimen by a central pathology review. Participants' safety will be monitored throughout the trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathological diagnosis of myxoid / round cell liposarcoma (MRCL) and availability of pathology specimens for central review and pharmacogenomic studies
- •Clinical evidence of locally advanced (Stage III), non-metastatic tumor, including locally recurring disease after initial surgery
- •Measurable disease (by Response Evaluation Criteria In Solid Tumors [RECIST])
- •No prior chemotherapy or radiation (except for adjuvant post-operative radiotherapy)
- •Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2
排除标准
- •Known hypersensitivity to any of the components of the trabectedin intravenous (iv) formulation or dexamethasone
- •Pregnant or lactating women and women of reproductive potential who are not using effective contraceptive methods
- •History of another neoplastic disease (except basal cell carcinoma or cervical carcinoma in situ adequately treated) unless in remission for 5 years or longer
- •Known distant metastases
- •Other serious illnesses such as congestive heart failure or angina pectoris, myocardial infarction within 1 year before enrollment, uncontrolled arterial hypertension or arrhythmias
研究组 & 干预措施
Trabectedin
Trabectedin at a dose of 1.5 milligram per meter square (mg/m^2) will be given as an intravenous (iv) infusion (a fluid or a medicine delivered into a vein by way of a needle) over 24-hour every 3 weeks for a minimum of 3 and a maximum of 6 cycles prior to definitive surgery. Dexamethasone 20 mg iv will also be administered within 30 minutes before start of each trabectedin infusion.
干预措施: Trabectedin (Drug)
Trabectedin
Trabectedin at a dose of 1.5 milligram per meter square (mg/m^2) will be given as an intravenous (iv) infusion (a fluid or a medicine delivered into a vein by way of a needle) over 24-hour every 3 weeks for a minimum of 3 and a maximum of 6 cycles prior to definitive surgery. Dexamethasone 20 mg iv will also be administered within 30 minutes before start of each trabectedin infusion.
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Percentage of Participants With Pathological Complete Response (pCR)
时间窗: Every 6 weeks until disease progression (up to Week 33) or 6 months post surgery.
Complete pathological response is complete disappearance of the tumor tissue up to the molecular level.
次要结局
- Percentage of Participants With Objective Tumor Response Based on Response Evaluation Criteria In Solid Tumors (RECIST)(Every 6 weeks until disease progression (up to Week 33) or 6 months post surgery.)