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临床试验/NCT03621904
NCT03621904招募中不适用

PROMOTE Study: Prediction of Response Of HorMOnal Treatment in Advanced and Recurrent Endometrial Cancer

Radboud University Medical Center1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2022年10月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
入组人数
150
试验地点
1
主要终点
Response rate

研究概览

简要总结

The PROMOTE study aims at optimising use of hormonal therapy in advanced stage and recurrent endometrial cancer analysing tumor tissue taken before start of hormonal therapy

详细描述

There is limited consensus about the position of hormonal treatment in advanced and metastatic endometrial carcinoma (EC). This is due to lack of good quality data on patient selection, and predictive biomarkers. Consequently, consideration of hormonal therapy is subjected to personal experience of the treating physician, rather than on refined clinical and up-to-date molecular criteria. Hormonal therapy has limited side-effects, and is better tolerated than systematic chemotherapy. Since EC patients are often elderly women with comorbidities, more effective and less aggressive treatment options are needed, underlining the urgency of an explorative study on this topic.

Endometrial cancer is the most common malignancy of the female genital tract in developed countries, with increasing incidence due to obesity and increased life expectancy. Most patients are diagnosed at an early stage, and have a favourable prognosis with surgery alone. Yet, 20% of the patients present with advanced or metastatic EC and have a poor outcome even with systemic treatment. Response rate of chemotherapy in advanced or metastatic EC is 30-60%, dependent of previous chemotherapy, with a progression free survival (PFS) of 3-14 months and 40% treatment related morbidity. In comparison, response to hormonal therapy is 20%-40%, with side effects in less than 5%. The overall PFS is 3 months, yet for those who respond the PFS can be up to several years.

To improve selective use of hormonal therapy in EC by evaluating applied hormonal therapy in advanced and metastatic EC and correlate response to molecular tumour analysis and translate this knowledge after validation into clinical practice

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 110 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Advanced stage (FIGO stage III and IV) and recurrent endometrial cancer
  • All histologic types of endometrial carcinoma
  • Planned treatment with any type of hormonal therapy
  • Biopsy taken within 120 days prior to start of hormonal therapy with no intercurrent therapy between biopsy and start of hormonal therapy.

排除标准

  • Adjuvant hormonal therapy started following complete resection of endometrial carcinoma
  • Synchronous use of hormonal therapy for other indications
  • Endometrial sarcoma or endometrial stroma cell sarcoma

研究组 & 干预措施

EC patients with HT

Patients with advanced stage or recurrent endometrial cancer treated with hormonal therapy

干预措施: Hormonal Antineoplastics (Drug)

结局指标

主要结局

Response rate

时间窗: 2 years

Complete or partial response according to RECIST criteria

Progression free survival

时间窗: 2 years

Interval from start of hormonal therapy to progressive disease or death

Clinical benefit rate

时间窗: 2 years

Complete or partial response or stable disease according to RECIST criteria

次要结局

  • Health-related quality of life(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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