The Use of Propranolol Hydrochloride Combined With Anthracyclin Based Chemotherapy in the Treatment of Metastatic Soft Tissue Sarcoma
试验速览
- 阶段
- 2 期
- 入组人数
- 50
- 主要终点
- Progression Free Survival
研究概览
简要总结
Fifty patients with pathological proof of malignant soft tissue sarcoma will receive Anthracyclin based chemotherapy combined with propranolol 40 mg twice daily.
- The primary end point : To assess Progression Free Survival (PFS)
- The secondary end points : To assess Overall Survival (OS) and Toxicity Profile
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologic or cytologic diagnosis of malignant soft tissue sarcoma.
- •ECOG less than or equal to 2 .
- •Measurable disease according to the requirements of modified RECIST criteria.
- •Age ≥ 19 years .
- •Estimated life expectancy of at least 12 weeks .
- •Adequate bone marrow reserve (white blood cells [WBC] ≥ 3.5 × 109 /L, neutrophils ≥ 1.5 × 109 /L, platelets ≥ 100 × 109 /L, and hemoglobin ≥ 9.0 gm/dL).
排除标准
- •Inadequate liver function (bilirubin > 1.5 times upper normal limit [UNL] and alanine transaminase [ALT] or aspartate transaminase [AST] > 3.0 UNL or up to 5.0 UNL in the presence of hepatic metastases).
- •Inadequate renal function (creatinine > 1.25 times UNL, creatinine clearance < 50mL/min).
- •Serious concomitant systemic disorder incompatible with the study.
- •Second primary malignancy (except in situ carcinoma of the cervix, adequately treated basal cell carcinoma of the skin, T1 vocal cord cancer in remission, or prior malignancy treated more than 5 years prior to enrollment without recurrence).
研究组 & 干预措施
propranolol hydrochloride with Doxorubicin
The patients suffering from metastatic soft tissue sarcoma will receive doxorubicin 60mg per square meter of body surface area every 21 days combined with propranolol hydrochloride 40mg twice daily
干预措施: Propranolol Hydrochloride (Drug)
propranolol hydrochloride with Doxorubicin
The patients suffering from metastatic soft tissue sarcoma will receive doxorubicin 60mg per square meter of body surface area every 21 days combined with propranolol hydrochloride 40mg twice daily
干预措施: Doxorubicin (Drug)
结局指标
主要结局
Progression Free Survival
时间窗: an average of 1 year
Progression free survival (PFS) is defined as the time interval between the dates of first treatment administration and first observation of PD.
次要结局
- Overall Survival(an average of 3 years)
研究者
Ahmed Nagy
Principal Investigator
Ain Shams University