NCT04765098招募中2 期
A Randomized Controlled Trial of Tamoxifen Versus Etoposide for Patients With First Recurrence of Glioblastoma Multiforme
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 3 month progression-free survival
研究概览
简要总结
The investigator propose a single-center randomized phase II controlled study designed to compare the management of first recurrence of GBM using etoposide versus tamoxifen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically proven GBM with progression after previous first line chemoradiotherapy with temozolomide.
- •Progression documented by MRI with at least one bi-dimensionally measurable target lesion with one diameter of at least 10 mm, visible on two or more axial slices 5 mm apart.
- •Not received radiotherapy within the three months before the diagnosis of progression.
- •Stable or decreasing dose of corticosteroids prior to randomization: corticosteroids (dexamethasone) should be given at the lowest dose needed to control symptoms arising from increased intracerebral edema.
- •ECOG performance 0-2 (Appendix 2).
- •Age from 18-65 years.
- •Women of child bearing potential (WOCBP) must have a negative serum (or urine) pregnancy test within 72 hours prior to the first dose of study treatment. WOCBP is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy or bilateral salpingectomy) and is not postmenopausal. Menopause is defined as 12 months of amenorrhea in a woman over age 45 years in the absence of other biological or physiological causes.
- •Patients of childbearing / reproductive potential should use adequate birth control methods, as defined by the investigator, during the study treatment period and for a period of 60 days after the last dose of study drug. A highly effective method of birth control is defined as those that result in low failure rate (i.e. less than 1% per year) when used consistently and correctly.
- •Note: abstinence is acceptable if this is established and preferred contraception for the patient and is accepted as a local standard.
- •Laboratory evaluation obtained within 7 days prior to randomization, with adequate function as defined below:
- •ANC ≥ 1.5 x 109/L
- •Platelets ≥ 100 x 109/L
- •Serum creatinine ≤ 1.5 times ULN
- •Total serum bilirubin ≤ 1.5 times ULN
- •ALT < 3 times ULN
- •AST < 3 times ULN
- •Alkaline phosphatase < 3 times ULN
- •Patient must understand and sign an informed consent prior to study registration.
排除标准
- •History of another malignancy or a concurrent malignancy (exceptions include patients who have been disease-free for 3 years, or patients with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible, for example cervical cancer in situ.
- •Uncontrolled hypertension (systolic blood pressure >150 mm Hg or diastolic blood pressure >100 mm Hg).
- •Any arterial or venous thrombosis up to 6 months before registration.
- •Evidence of recent hemorrhage on brain MRI.
- •Substantial cardiovascular disease: cerebral vascular accident/stroke (<6 months prior to enrollment), myocardial infarction (<6 months prior to enrollment), unstable angina, congestive heart failure (> New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication.
研究组 & 干预措施
Etoposide
Active Comparator
干预措施: Etoposide (Drug)
Tamoxifen
Experimental
干预措施: Tamoxifen (Drug)
结局指标
主要结局
3 month progression-free survival
时间窗: 3 months
Time between randomization and radiographic or clinical progression leading to change in therapy for recurrent disease or death due to any cause.
次要结局
- Health-related quality-of-life status(Throughout study completion, up to 5 years.)
- One-year progression-free survival(12 months)
- Adverse events(Throughout the whole duration of the trial, up to 5 years)
- Overall survival(Median, 6-month, 1-year, and 2-year OS rates will be measured)
研究者
研究点 (1)
Loading locations...
相似试验
Unknown
2 期
TAmoxifen Versus LIdocaine Cream. A Randomized Clinical Trial for Reducing Pain and Discomfort During MammographyPainDiscomfortNCT02801786Universidade Federal de Goias450
进行中（未招募）
2 期
Tamoxifen Citrate or Z-Endoxifen Hydrochloride in Treating Patients With Locally Advanced or Metastatic, Estrogen Receptor-Positive, HER2-Negative Breast CancerRecurrent Breast CarcinomaStage III Breast Cancer AJCC v7Stage IIIA Breast Cancer AJCC v7Stage IIIB Breast Cancer AJCC v7Stage IIIC Breast Cancer AJCC v7Stage IV Breast Cancer AJCC v6 and v7NCT02311933National Cancer Institute (NCI)81
已完成
3 期
ATAC - Arimidex, Tamoxifen Alone or in CombinationBreast CancerNCT00849030AstraZeneca9,358
已完成
2 期
Treatment With Tamoxifen in Cryptococcal MeningitisMeningitis StreptococcalHivMeningoencephalitisMeningitisNCT03112031Oxford University Clinical Research Unit, Vietnam50
已完成
3 期
PROACT - Pre-Operative Arimidex Compared To TamoxifenBreast CancerNCT00232661AstraZeneca452