ISRCTN43261139已完成2 期
Phase II study of Aromatase inhibitors in women with potentially hormone Responsive recurrent/metastatic Gynaecological Neoplasms (PARaGoN)
HS Greater Glasgow and Clyde (UK)0 个研究点目标入组 350 人开始时间: 2012年1月12日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 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
入排标准
- 性别
- Female
入选标准
- •1. Patient with recurrent or metastatic gynaecological cancer. The specific subgroups are outlined below. All patients will have central review and analyses of oestrogen receptor/progesterone receptor (ER/PR) at a later date to confirm receptor status but entry to the study will be based on local hormone receptor analyses.
- •1.1. Epithelial ovarian cancer, primary peritoneal cancers and cancers of the fallopian fube
- •1.2. Endometrial cancer: patients that have measurable disease
- •1.3. Endometrial stromal sarcomas: patients that have measurable disease
- •1.4. 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.
- •1.5. Granulosa cell tumours and other sex cord tumours: patients with measurable disease and/or elevated inhibin (total inhibin and/or inhibin B? level
- •1.6. UK centres will only enter patients to subgroups B-E of the study
- •2. 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.
- •3. Post menopausal as defined by:
- •3.1. Aged 60 or more, or
- •3.2. Age 45-59 and has amenorrhoea for at least 12 months and follicle-stimulating hormone (FSH) in postmenopausal range with an intact uterus, or having had a bilateral oophorectomy
- •4. Evaluable disease defined as
- •4.1. Measurable disease as per Response Evaluation Criteria In Solid Tumours (RECIST) v1.1, or
- •4.2. Cancer antigen 125 (CA125) as per GCIG criteria (for ovarian cancer subgroup) or
- •4.3. Elevated total inhibin and/or inhibin B (for granulosa cell sub-group)
- •5. Eastern Cooperative Oncology Group (ECOG) peformance status 0-2
- •6. Expected survival > 3 months
排除标准
- •Prior therapy with an aromatase inhibitor:
- •1. Patients receiving any hormone replacement therapy
- •2. Inability to comply with study procedures
- •3. Unable to give informed consent
- •4. 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
- •5. Significant hepatic (bilirubin >2xULN) or renal dysfunction (creatinine>3x ULN)
研究者
相似试验
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
3 期
Effect of Aromatase inhibitors combination with oral contraceptive pills versus GnRH agonist on uterine myomaterine Myoma.Leiomyoma of uterusIRCT20140820018866N7Tehran University of Medical Sciences42
进行中（未招募）
1 期
PARAGON - Phase II study of aromatase inhibitors in women with potentially hormone responsive recurrent/metastatic gynaecological neoplasmsPatients with potentially hormone responsive recurrent or metastatic gynaecological cancers from following subgroups:A - Epithelial ovarian cancer, primary peritoneal cancers and cancers of the fallopian tubeB- Endometrial cancerC- Endometrial Stromal SarcomasD- Miscellaneous SarcomasE- Granulosa Cell Tumours and other Sex Tumours * UK sites will only enter patients to subgroups B-E *MedDRA version: 14.1Level: LLTClassification code 10026310Term: Malignant neoplasm of ovarySystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: LLTClassification code 10014760Term: Endometrial neoplasm malignantSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2011-000501-52-GBGreater Glasgow and Clyde350
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
已完成
1 期
Comparing the effect of Aromatase inhibitor (Letrozol) + Cabergoline (Dostinex) and letrozol alone on uterine myoma regressioIRCT201506205283N12Vice chancellor for Research,Tabriz University Of Medical Sciences76