NCT00171808已完成2 期
Phase II Study on Letrozole in Patients With Advanced or Recurrent Hormone Receptor Positive Endometrial Cancer
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
- 26
- 试验地点
- 7
- 主要终点
- clinical response rate (partial response PR and complete response CR) according to RECIST at least once during the treatment period
研究概览
简要总结
In Western industrialized countries, endometrial cancer is the most common malignancy of the female reproductive tract.
The general therapy options are surgery, radiotherapy, chemotherapy and endocrine therapy. This trial will investigate the efficacy and safety of letrozole in the treatment of advanced or recurrent hormone receptor-positive endometrial cancer .
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent
- •Age > 18 years
- •Presence of histologically proven adenocarcinoma or adenosquamous carcinoma of the endometrium
- •Presence of advanced or recurrent endometrial cancer, FIGO stage I-IV, incurable with surgery and/or radiation therapy
- •Documented ER and/or PgR positive endometrial cancer. Hormone receptor positivity is defined according to routine practice at each participating laboratory.
- •Patient must be postmenopausal defined as
- •Age ≥55 years.
- •Age <55 but no spontaneous menses for at least 1 year.
- •Age <55 and spontaneous menses within the past 1 year, but currently amenorrheic (e.g., spontaneous or secondary to hysterectomy), and with postmenopausal gonadotrophin levels (luteinizing hormone and follicle stimulating hormone levels >40 IU/L) or postmenopausal estradiol levels (<5 ng/dL) or according to the definition of "postmenopausal range" for the laboratory involved.
- •Bilateral oophorectomy
- •Radiation menopause
- •Presence of measurable disease (by clinical/radiological examination - according to RECIST criteria : minimum indicator lesion size : 20 mm (unless spiral CT scan in which case > 10 mm)
- •ECOG performance status of 0, 1 or 2
- •Adequate bone marrow function (WBC ≥ 3.5 x 1'000'000'000/L and platelets ≥ 100.0 x 1'000'000'000/L) and hemoglobin > 10.0 g/dl
- •Adequate renal function (creatinine < 120 µmol/L) and hepatic function (bilirubin < 25 µmol/L, AST (SGOT < 60 U/L)
- •Minimum life expectancy of at least 6 months
- •Patients who are accessible for treatment and follow-up
排除标准
- •Presence of non-measurable disease only
- •Other concomitant anti-cancer treatment (except external radiation treatment [XRT] for symptomatic metastatic lesions if other assessable untreated lesions are present)
- •Prior treatment with aromatase inhibitors or anti-estrogens (up to one previous progestational hormone therapy regimen for recurrent disease is permitted)
- •Clear cell or papillary serous histology, uterine sarcomas, mixed Mullerian tumors (MMT) and/or adenosarcomas
- •Other concurrent malignant disease with the exception of cone-biopsied in situ carcinoma of the cervix uteri, or adequately treated basal or squamous cell carcinoma of the skin, or other curable cancers e.g. Hodgkin's disease or non-Hodgkin lymphoma (NHL), provided 5 years have elapsed from completion of therapy, and there has been no recurrence
- •Known central nervous system (CNS) metastases, bilateral diffuse lymphangiosis carcinoma of the lung (>50 % of lung involvement, or dyspnea at rest requiring supplemental oxygen therapy), evidence of metastases estimated as more than a third of the liver as defined by sonogram and/or CT scan
- •Uncontrolled endocrine disorders such as diabetes mellitus, confirmed hypo- or hyperthyroidism, Cushing's Syndrome, Addison's disease (treated or untreated)
- •Unstable angina and uncontrolled cardiac disease
- •Treatment with other investigational drugs (drugs not marketed for any indication) within the past 30 days and/or the concomitant use of investigational drugs
- •A history of non-compliance to medical regimens and patients who, in the opinion of the investigator, are unlikely to cooperate fully during the study
- •Inability to swallow pills
- •Additional protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
Letrozole
Experimental
干预措施: Letrozole (Drug)
结局指标
主要结局
clinical response rate (partial response PR and complete response CR) according to RECIST at least once during the treatment period
时间窗: until disease progression
次要结局
- Overall survival (OS)(until disease progression)
- Time to progression (TTP)(until disease progression)
研究者
研究点 (7)
Loading locations...
相似试验
已完成
2 期
A Study of Letrozole in the Treatment of Endometrial CancerRecurrent and Metastatic Endometrial CancerNCT00333086Novartis Pharmaceuticals36
已完成
不适用
Diet and Physical Activity in Uterine Cancer SurvivorsEndometrial NeoplasmsNCT02433080University College, London60
招募中
2 期
ALPINE: Maintenance Letrozole/AbemaciclibEndometrial CancerRecurrent Endometrial CancerTP53NCT06366347Dana-Farber Cancer Institute32
招募中
不适用
A Prospective Study Comparing Three Injection Sites to Detect Sentinel Lymph Nodes in Endometrial CancerEndometrial CancerNCT04577950Centre Hospitalier Universitaire Vaudois120
已完成
不适用
Combination Chemotherapy of Paclitaxel and Carboplatin With or Without Anthracycline as Aneo Adjuvant Treatment in Advanced Endometrial CarcinomaEndometrial CarcinomaNCT06102252Sohag University60