NCT01639625已完成2 期
Open Clinical Trial, Uncontrolled in Patients Bearing Squamous Cell Carcinoma or Adenocarcinoma of the Cervix Stage IIA and IIB FIGO Classification Treated With Radiotherapy External Endocavitary Brachytherapy + Concurrent Hemotherapy Weekly Systemic and Local Application of CIGB-300 Dose Escalation
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Number of patients with presence or absence of grade 3 or 4 adverse events related to the study drug, in each dose level
研究概览
简要总结
They include patients who are candidates to complete concurrent treatment with endocavitary brachytherapy External radiation therapy + more QT based weekly cisplatin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Stages IIA and IIB FIGO classification.
- •Age between 21 to 70 years.
- •ECOG performance status 0-
- •No history of another neoplastic disease.
- •Value of Hemoglobin ≥ 9 g / l.
- •Total leukocyte count ≥ 3.0 x 109 / L.
- •Absolute neutrophil count ≥ 1.5 x 109 / L.
- •Platelets ≥ 100,000 x mm
- •Total bilirubin ≤ 1.5 times ULN, SGOT and SGPT ≤ 2.5 times upper limit of normal.
- •Creatinine ≤ 2 mg / dL and creatinine clearance calculated ≥ 60 ml / min(according to Cockcroft-Gault formula)
- •Patients of childbearing age who are using an adequate contraception method during treatment to prevent pregnancy.
- •Life expectancy ≥ 12 months
- •Measurable disease
- •Informed consent signed by the patient
排除标准
- •Pregnancy and lactation period.
- •Presence of lymph node metastases or hematogenous extrapelvic known.
- •Uncontrolled intercurrent diseases, including active infection, symptomatic congestive heart failure, unstable angina or cardiac arrhythmia and psychiatric illness involving incompetence of the patient.
- •Other malignancies, with the exception of basal cell carcinoma or other tumor that appropriate treatment is received showing a disease-free period ≥ 5 years.
- •Hepatitis B or C active, positive serology for HIV.
- •Atopy history of severe / severe asthma.
- •A history of autoimmune disease.
- •Presence of significant abnormalities in ECG performed within 14 days prior to admission.
- •Diseases that prevent the patient give informed consent or their ability to collaborate in the trial.
- •Participating in another clinical trial "
研究组 & 干预措施
CIGB300
Experimental
干预措施: CIGB300 (Drug)
结局指标
主要结局
Number of patients with presence or absence of grade 3 or 4 adverse events related to the study drug, in each dose level
时间窗: Up to 2 years
次要结局
- Number of patients with local relapses(Up to 2 years)
- Number of patients with distant relapses(Up to 2 years)
研究者
研究点 (1)
Loading locations...
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