Refining Adjuvant treatment IN endometrial cancer Based On molecular features, TransPORTEC platform trials – p53abn - RED Randomized phase III trial testing maintenance olaparib versus observation after adjuvant chemoradiation for p53abn endometrial cancer
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 554
- 试验地点
- 1
- 主要终点
- Recurrence free survival (RFS) in patients with p53abn EC, as assessed by the investigator.
研究概览
简要总结
The endometrial cancer classification has recently been changed by the integration of surrogate molecular markers allowing the identification of four distinct endometrial cancer subtypes. Evidence from our group show that not only prognosis, but also adjuvant treatment benefit depends on which molecular EC subtype a patients has. High risk EC (HREC) patients belonging to the p53abn EC subgroup are the ones who benefited the most from concurrent chemoradiation suggesting frequent HR deficiency. We hypothesize that patients with early p53abn EC will benefit from olaparib as maintenance resulting in an increase in RFS and ultimately OS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- Female
入选标准
- •WHO Performance score 0-1 Histologically confirmed Stage I to III EC with myometrial invasion Molecular classification p53abn EC Body weight less than 30 kg.
排除标准
- •Major surgical procedure (as defined by the Investigator) within 2 weeks prior randomization and patients must have recovered from any effects of any major surgery.
- •History of allogenic organ transplantation.
- •Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, Patient with severe hepatic impairment Any previous treatment with a PARP inhibitor, including olaparib.
- •History of active primary immunodeficiency History or evidence of hemorrhagic disorders within 6 months prior to randomization Patients with myelodysplastic syndrome/acute myeloid leukemia history or with features suggestive of MDS or AML.
- •Previous allogenic bone marrow transplant or double umbilical cord blood transplantation (dUCBT) Active infection including tuberculosis Concomitant use of known strong CYP3A inhibitors or inducers Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication.
- •Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent.
- •Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent Patients with a known hypersensitivity to olaparib or any of the excipients of the product.
- •Treatment with an unlicensed or investigational product within 4 weeks of trial entry.
- •Pregnant and breastfeeding patients.
结局指标
主要结局
Recurrence free survival (RFS) in patients with p53abn EC, as assessed by the investigator.
时间窗: Baseline to 12 months- Recurrence free survival (RFS) in patients with p53abn EC, as assessed by the investigator.
次要结局
- Overall survival (OS)
- Disease-specific survival
- Vaginal recurrence-free survival(0-36 months)
- Pelvic recurrence-free survival
- Distant recurrence-free survival(0-36 months)
研究者
Asima Mukhopadhyay
KolGOTrg