EUCTR2019-002264-27-AT进行中（未招募）1 期
MAintenance Therapy with Aromatase inhibitor in epithelial Ovarian cancer: a randomized double-blinded placebo-controlled multi-center phase III Trial (ENGOT-ov54/Swiss-GO-2/MATAO) including LOGOS (Low Grade Ovarian cancer Sub-study) - MATAO
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 540
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
- •· Patients must be = 18 years of age
- •· Willing and able to attend the visits and to understand all study-related
- •procedures.
- •· Primary, newly diagnosed FIGO Stage II to IV and histologically
- •confirmed low or high grade serous or endometrioid epithelial
- •ovarian/fallopian tube/peritoneal cancer
- •· (Interval-) debulking performed
- •· ECOG-Performance Status 0-2
- •· Signed informed consents (ICF-1; ICF-2)
- •· Paraffin-embedded tissue or paraffin-embedded cell block (from ascites)
- •· Positivity (= 1%) for ER expression (only determined by Histopathology
- •Core Facility of MATAO trial)
- •· At least 4 cycles of platinum-based chemotherapy (neoadjuvant allowed)
- •· Negative serum pregnancy test in women of childbearing potential who will get/have gotten a surgical resection or radiation sterilization, prior to the intervention in the therapeutical maintenance setting.
- •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 270
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 270
排除标准
- •Progressive disease at the end of adjuvant treatment
- •Women of childbearing potential (not having undergone a surgical or radiation sterilization and not getting a surgical resection, prior to the intervention in the therapeutical maintenance setting)
- •Pregnant or lactating women
- •Any other malignancy within the last 5 years which has impact on the prognosis of the patient
- •< 4 cycles of chemotherapy in total
- •Contraindications to endocrine therapy
- •Inability or unwillingness to swallow tablets
- •Patients with a known intolerance to galactose, lactase deficiency and glucose-galactose mal-absorption
研究者
相似试验
招募中
3 期
MAintenance Therapy with Aromatase inhibitor in epithelial Ovarian cancerepithelial ovarian cancer2024-511219-78-00Swiss GO Trial Group300
招募中
3 期
MAintenance Therapy With Aromatase Inhibitor in Epithelial Ovarian Cancer (MATAO)Ovarian Neoplasm EpithelialFallopian Tube NeoplasmsPeritoneal NeoplasmsHigh-grade Serous Ovarian Carcinoma (HGSOC)Low-grade Serous Ovarian Carcinoma (LGSOC)Ovarian Endometrioid CarcinomaNCT04111978Swiss GO Trial Group540
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
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
已完成
不适用
se of non steroidal aromatase inhibitors in treatment of patients with early invasive hormone-dependent breast cancer in everyday clinical practiceEarly invasive hormone-dependent breast cancerMalignant neoplasm of breastCancerISRCTN95653203PLIVA Croatia Ltd. (Croatia)500