CTRI/2012/02/002401Other3 期
A Phase III multicenter, international, randomized, double-blind, placebo-controlled study of doxorubicin plus palifosfamide-tris vs. doxorubicin plus placebo in patients with front-line metastatic soft tissue sarcoma.
试验速览
- 阶段
- 3 期
- 状态
- Other
- 入组人数
- 424
- 试验地点
- 7
- 主要终点
- Progression Free Survival followed by Overall Survival
研究概览
简要总结
This is an international, randomized, double-blind, placebo-controlled trial to evaluate the clinical efficacy of palifosfamide-tris administered with doxorubicin in combination, compared with doxorubicin administered with placebo in front-line patients diagnosed with metastatic soft tissue sarcoma (STS). Patients who meet the entry criteria will be randomized equally into 1of 2 arms: either to receive doxorubicin plus palifosfamide-tris or doxorubicin plus placebo. xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Age more than or equal to 18 years and less than 65 years.
- •Documented soft tissue sarcoma
- •Metastatic disease for which the patient has not received any prior treatment, and for whom treatment with doxorubicin is considered medically acceptable.
- •ECOG Performance Status of 0, 1 or 2
- •Adequate bone marrow and organ function based on the results of protocol- specified laboratory tests
- •Male and female patients must agree to use a highly reliable method of birth control during study participation.
排除标准
- •Age more than 65 years
- •Specific sarcoma histological subtypes including GIST and Ewings sarcoma.
- •Systemic therapy for the treatment of metastatic sarcoma, prior to or during the study.
- •However, patients may have received neo-adjuvant/adjuvant Gemzar and Taxotere chemotherapy for their primary sarcoma, prior to the development of metastatic disease
- •Any prior anthracycline use.
- •Known allergy to any of the study drugs or their excipients.
- •Any unstable or clinically significant concurrent medical condition that would, in the opinion of the investigator, jeopardize the safety of a patient and/or their compliance with the protocol, based on screening tests, physical examination and medical history (as specifically defined in the clinical protocol).
- •Myocardial dysfunction defined as left ventricular ejection fraction (LVEF) 50 percent.
- •Documented metastases to brain or meninges.
- •Any malignancy other than sarcoma within the last 5 years prior to screening, with the exception of cervical carcinoma in situ, basal cell carcinoma, or superficial bladder tumors (Ta, Tis, or T1) that have been successfully and curatively treated with no evidence of recurrent or residual disease.
- •Currently pregnant or nursing.
- •Radiotherapy with curative intent within 4 weeks of first dose of study drug.
结局指标
主要结局
Progression Free Survival followed by Overall Survival
时间窗: Time Frame - Assessed every 6 weeks for 22 weeks, then 8 weeks for 6 months or until progression, then every 12 weeks until then death.
次要结局
- Quality of Life, as assessed by EORTC QLQ-C30 and EQ-5D questionnaires(Time Frame - Assessed every 6 weeks for 22 weeks, then 8 weeks for 6 months, then every 12 weeks until death)
- Safety and Tolerability as evaluated using CTCAE v 4.0(Time Frame - 22 weeks)
研究者
研究点 (7)
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