EUCTR2011-000501-52-GB进行中（未招募）1 期
PARAGON: Phase II study of aromatase inhibitors in women with potentially hormone responsive recurrent/metastatic gynaecological neoplasms - PARAGO
Greater Glasgow and Clyde0 个研究点目标入组 350 人开始时间: 2011年8月23日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 350
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
- Female
入选标准
- •- Patient with recurrent or metastatic gynaecological cancer. 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
- •B- Endometrial Cancer:Patients that have measurable disease
- •C- Endometrial Stromal Sarcomas: Patients that have measurable disease
- •D - Miscellaneous Sarcomas : Includes leimyosarcomas,adenosarcomas,carcinoasrcomas and undifferentiated 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 Tumours : patients that measurable disease and/or elevated inhibin (total inhibin and/or inhibin B? level
- •** Please note UK centres will only enter patients to subgroups B-E of the study.
- •- All patients must have ER and/or PR positive tumours by immunohistochemical evaluation based on the assessment at individual sites. Hormone receptor staining should be carried out on the original tumour. If not available, but the recurrent tumour is receptor positive, then these patients will be eligible.
- •- Post menopausal as defined by: i.) aged 60 or more, or ii.) age 45-59 and satisfting 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; i.)measurable disease as per RECIST v1.1, OR
- •ii.) CA125 as per GCIG criteria (for ovarian cancer subgroup) OR iii.)elevated total inhibin and/or inhibin B (for granulosa cell sub-group)
- •- ECOG peformance status 0-2
- •- Expected survival > 3 months
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 250
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
排除标准
- •- Prior therapy with an aromatase inhibitor
- •- Patients receiving any hormone replacement therapy
- •- 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 >2xULN) or renal dysfunction (creatinine>3x ULN)
研究者
相似试验
招募中
2 期
Investigation of the effect of letrozole in the treatment of ectopic pregnancies compared to methotrexate.IRCT20170828035961N2Esfahan University of Medical Sciences40
进行中（未招募）
不适用
Phase II study of aromatase inhibitors in women with potentially hormone responsive recurrent/metastatic gynaecological neoplasmsWomen with oestrogen receptor and/or progesterone receptor positive (ER/PR+ve) potentially hormone responsive recurrent or metastatic gynaecological cancer including selected patients with epithelial ovarian cancer, endometrial cancers, miscellaneous sarcomas and sex cord stromal tumours of the ovaryEUCTR2011-003192-11-BEniversity of Sydney
招募中
2 期
AFTER trialmetastatic postmenopausal breast cancer with refractory to estrogen therapyJPRN-UMIN000013890Department of Breast and Endocrine Surgery Graduate school of Medical Sciences, Kumamoto University60
已完成
2 期
Study of aromatase inhibitors in women with potentially hormone responsive recurrent/metastatic gynaecological cancersHormone responsive recurrent/metastatic gynaecological neoplasmsMalignant neoplasms of female genital organsCancerISRCTN43261139HS Greater Glasgow and Clyde (UK)350
已完成
不适用
A randomised trial of sequential aromatase inhibitors (AI) in postmenopausal women with locally advanced or metastatic breast cancerCancerBreast cancerISRCTN99515843International Collaborative Cancer Group (ICGG) (UK)