NL-OMON43520已完成2 期
A phase II trial of TTFields in addition to pemetrexed and cisplatin or carboplatin as first-line treatment in malignant pleural mesothelioma - EF-23 STELLAR Study
ovocure Ltd.0 个研究点目标入组 27 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 27
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
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Pathological or histological evidence of mesothelioma.
- •2. * 18 years of age
- •3. Not candidate for curative treatment (surgery or radiotherapy)
- •4. At least 4 weeks since major surgery
- •5. At least one measurable or evaluable lesion according to modified RECIST Criteria
- •6. ECOG Performance Status (PS) of 0-1.
- •7. Life expectancy of at least 3 months.
- •8. Participants of childbearing age must use effective contraception as indicated by the investigator
- •9. All subjects must sign written informed consent.
- •10. Able to operate the NovoTTF-100L System independently or with the help of a caregiver.
排除标准
- •1. Patient candidate for surgery or radiotherapy with curative intent
- •2. Previous chemotherapy or radiation
- •3. Prior malignancy requiring anti-tumor treatment (apart from in*situ cervical cancer, in situ breast cancer, non-melanomatous skin cancers, or any malignancy for which
- •treatment was received and there is no evidence of disease for at least 5 years) or
- •concurrent malignancy.
- •4. Significant co-morbidities within 4 weeks prior to enrollment, resulting in the following
- •laboratory findings:
- •a) Significant liver function impairment:
- •* AST or ALT > 3 times the upper limit of normal
- •* Total bilirubin > 1.5 upper limit of normal
- •b) Significant renal impairment (serum creatinine > 1.7 mg/dL)
- •c) Coagulopathy (as evidenced by PT or APTT >1.5 times control in subjects not receiving anticoagulants)
- •d) Thrombocytopenia (platelet count < 100 x 10e3/*L*
- •e) Neutropenia (absolute neutrophil count < 1.5 x 10e3/*L*
- •f) Anemia (Hb < 10 g/dL)
- •g) Severe acute infection
- •5. Significant comorbidity which is expected to affect patient's prognosis or ability to receive the combined therapy:
- •a) History of significant cardiovascular disease unless the disease is well controlled. Significant cardiac disease includes second/third degree heart block; significant ischemic heart disease; poorly controlled hypertension; congestive heart failure of the New York Heart Association (NYHA) Class II or worse (slight limitation of physical activity; comfortable at rest, but ordinary activity results in fatigue, palpitation or dyspnea).
- •b) History of arrhythmia that is symptomatic or requires treatment. Patients with atrial fibrillation or flutter controlled by medication are not excluded from participation in the trial
- •c) Active infection or any serious underlying medical condition that would impair the ability of the patient to receive protocol therapy.
- •d) History of any psychiatric condition that might impair the patient's ability to understand or comply with the requirements of the study or to provide consent.
- •6. Untreated brain metastases. Asymptomatic, pretreated brain metastases not requiring steroids are allowed
- •7. Implanted pacemaker, defibrillator or other electrical medical devices
- •8. Known allergies to medical adhesives or hydrogel
- •9. Pregnant or breast feeding (all patients of childbearing potential must use effective contraception method during the entire period of the study based on the recommendation of the investigator or a gynecologist)
- •10. Admitted to an institution by administrative or court order
研究者
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