EUCTR2011-003192-11-BE进行中（未招募）不适用
Phase II study of aromatase inhibitors in women with potentially hormone responsive recurrent/metastatic gynaecological neoplasms
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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
入选标准
- •*patients with recurrent or metastatic gynaecological cancers. The specific subgroups are outlined below. All patients will have central review and analyses of ER/PR at a later date to confirm receptor status but entry to the study will be based on local hormone receptor analyses.
- •A.Epithelial ovarian cancer, primary peritoneal cancers and cancers of the fallopian tube.
- •*Asymptomatic patients with a rising CA125 after first line chemotherapy and GCIG defined CA125 progression (these patients should either have no measureable disease or small volume recurrence and the expectation they would not require chemotherapy within the next 12weeks)
- •*Borderline ovarian tumours, micro-invasive ovarian tumours and well differentiated low grade ovarian cancers. Apart from surgery, treatment options are very limited for these patients as these tumours are usually chemotherapy resistant but are also relatively indolent
- •*palinum resistant or refractory ovarian, fallopian tube and primary peritoneal cancer in patients in whom further chemotherapy is not indicated.
- •B.Endometrial cancer- patients that have measureable disease
- •C.Endometrial stromal sarcomas: patients that have measureable disease
- •D.Miscellaneous Sarcomas: includes leiomyosarcomas, adenosarcomas, carcinosarcomas and undifferentiated uterine sarcomas which have relapsed following standard treatment such as chemotherapy or patients in whom chemotherapy is not considered appropriate
- •E.Granulosa cell tumours and other sex cord stromal tumours: patients that have measurable disease and/or an elevated inhibin (total inhibin and/or inhibin B)level
- •*All patients must have ER and/or PR positive tumours by immunohistochemical evaluation based on the assessment at individual sites. Hormone receptor staining shoul be carried out on the original tumour. If not availbale, but the recurrent tumour is receptor positive, then these patients will also be eligible.
- •*post-menopausal as defined by: age 60 or more, or age 45-59 and satisfying the following criteria: amenorrhoea for at least 12 months and FSH in postmenopausal range with an intact uterus, or having had a bilateral oophorectomy
- •*evaluable disease defined as: measurable disease as per RECIST v1.1 OR CA125 as per GCIG criteria (for ovarian cancer subgroup) or elevated total inhibin and/or inhibin B (for granulosa cell sub-group)
- •*ECOG performance status 0-2
- •*Expected survival >3 months
- •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 10
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •*prior therapy with an aromatase inhibitor
- •*patients receiving any hormone replacement therpay
- •*Inability to comply with study procedures
- •*Unable to give informed consent
- •*Other active malignancy or primary malignancy diagnosed within the previous 5 years, except for treated squamous or basal cell carcinoma of skin or cervical carcinoma
- •*significant hepatic (bilirubin >2x ULN) or renal dysfunction (creatinine > 3x ULN)
研究者
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