2024-511219-78-00招募中3 期
MATAO 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)
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 32
- 主要终点
- The primary outcome is Progression-Free Survival (PFS), defined as the time from randomization until the date of progression (recurrence) or death by any cause in the absence of progression.
研究概览
简要总结
To evaluate the efficacy of letrozole maintenance therapy after standard surgical and chemotherapy treatment as measured by Progression Free Survival (PFS) compared to no maintenance therapy (placebo)
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients must be ≥ 18 years of age
- •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.
- •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) available
- •Positivity (≥ 1%) for ER expression (only determined by Histopathology Core Facility of MATAO trial)
- •At least 4 cycles of platinum-based chemotherapy (neoadjuvant allowed)
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
结局指标
主要结局
The primary outcome is Progression-Free Survival (PFS), defined as the time from randomization until the date of progression (recurrence) or death by any cause in the absence of progression.
The primary outcome is Progression-Free Survival (PFS), defined as the time from randomization until the date of progression (recurrence) or death by any cause in the absence of progression.
次要结局
- Overall Survival (OS), defined for each patient as the time from randomization until the date of death from any cause.
- Quality-Adjusted Progression Free Survival (QAPFS), defined as the time from randomization until the date of progression (recurrence) or death by any cause in the absence of progression under consideration of the quality of life during this period.
- Time until First Subsequent Therapy (TFST), defined for each patient as the time from randomization until the date the patient started the next (second line) subsequent anticancer treatment. Patients not receiving a subsequent anticancer treatment at the time of analysis will be censored at the date they were last known to be alive.
- Quality adjusted Time Without appearance of any Symptoms and Toxicity (Q-TWiST), related to either the progression of the cancer or side effects of the trial medication from randomization until death.
研究者
Pamela McLaughlin
Scientific
Swiss GO Trial Group
研究点 (32)
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