EUCTR2006-003007-39-NL进行中（未招募）1 期
Phase I/II Study of Concurrent Cisplatin, Pemetrexed, and Radiotherapy for Limited Stage Small Cell Lung Cancer - N/A
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Patients may be included in the study only if they meet all of the following criteria:
- •[1] Histologic and/or [cytologic] diagnosis of LS-SCLC, without cytological proven malignant pleural effusion and confined to one hemithorax as defined by the IASLC 1989 criteria (
- •[2] Performance status of 0 to 1 on the ECOG performance status schedule
- •[3] no prior chemo- and/ or prior thoracic radiotherapy
- •[4] Measurable disease defined by:
- •At least one unidimensionally measurable lesion meeting RECIST criteria
- •[5] adequate organ function including the following:
- •Adequate bone marrow reserve: absolute neutrophil (segmented and bands) count (ANC) =1.5 x10e9/L, platelets =100 x10e9/L, and hemoglobin =9 g/dL.
- •Hepatic: bilirubin < or = 1.5 times the upper limit of normal (x ULN), alkaline phosphatase (AP), aspartate transaminase (AST) and alanine transaminase (ALT) < or = 3.0 x ULN.
- •Renal: calculated creatinine clearance (CrCl) =60mL/min based on the standard Cockroft and Gault formula
- •[6] adequate pulmonary function as defined as a Forced Expiratory Volume in 1 sec (FEV1) > 30% predicted normal value and diffusion capacity (DLCO) > 40% predicted normal value.
- •[7] unlikely to be at excessive risk for radiation pneumonitis as defined by a V20 of =36% and able to drain 3rd space fluids
- •[8] Patient compliance and geographic proximity that allow adequate follow-up.
- •[9] Patients must sign an informed consent document.
- •[10] Patients must be at least 18 years of age.
- •[11] For women: Must be surgically sterile, post-menopausal, or compliant with a medically approved contraceptive regimen during and for 3 months after the treatment period; must have a negative serum or urine pregnancy test and must not be lactating.
- •For men: Must be surgically sterile, or compliant with a contraceptive regimen during and for 3 months after the treatment period.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients will be excluded from the study if they meet any of the following criteria:
- •[12] Treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
- •[13] Completion or withdrawal from this study or any other study investigating pemetrexed.
- •[14] Patients with myocardial infarction within the preceding six months or symptomatic heart disease, including angina, congestive heart failure, or uncontrolled arrhythmia.
- •[15] Diagnosis of a serious concomitant systemic disorder (for example, active infection including HIV) that, in the opinion of the investigator, would compromise the patient’s ability to complete the study.
- •[16] Prior radiotherapy to the lower neck or abdominal region.
- •[17] Discovery of a second primary malignancy that is clinically detectable at the time of consideration for study enrollment.
- •[18] Significant weight loss (that is, U>10%) over the previous 6 weeks before study entry.
- •[19] Concurrent administration of any other antitumour therapy.
- •[20] Inability to interrupt aspirin or other nonsteroidal anti-inflammatory agents, other than an aspirin dose =1.3 grams per day, for a 5-day period (8-day period for long-acting agents, such as piroxicam).
- •[21] Inability or unwillingness to take folic acid or vitamin B12 supplementation.
- •[22] Inability to take corticosteroids.
- •[23] Inability to comply with protocol or study procedures.
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