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临床试验/NCT05655260
NCT05655260
招募中
不适用

PErsonalized TReatment for Endometrial Carcinoma

University of Helsinki1 个研究点 分布在 1 个国家目标入组 300 人2022年2月8日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Endometrial Adenocarcinoma
发起方
University of Helsinki
入组人数
300
试验地点
1
主要终点
Cancer reappearance
状态
招募中
最后更新
去年

概览

简要总结

The goal of this clinical trial is to compare the efficacy of adjuvant therapies in women with stage I-II molecular integrated high-intermediate or high-risk endometrial carcinoma. Specifically, the invesigators want to compare:

  • Chemotherapy vs. chemoradiotherapy in p53 abn subtype and nonendometrioid carcinomas.
  • Vaginal brachytherapy vs. whole pelvic radiotherapy in the MMR-D molecular subgroup.
  • Vaginal brachytherapy vs. whole pelvic radiotherapy in the NSMP molecular subgroup.

详细描述

Endometrial carcinomas can be classified into four molecular subgroups, i.e. mismatch repair deficient (MMR-D), p53 abnormal (p53 abn), polymerase-ϵ (POLE) ultramutated, and "no specific molecular profile" (NSMP). Molecular subgroups can be considered to be distinct diseases as they are associated with different clinicopathologic characteristics, prognoses and, possibly, responses to adjuvant therapy. Molecular classification of endometrial carcinoma is recommended to be implemented in routine clinical practice to improve prognostication and triage to adjuvant therapy. The PErsonalized TReatment for Endometrial Carcinoma (PETREC) trial, led by the Finnish Gynecologic Oncology Group (FINGOG), is a multicenter prospective clinical trial for women with stage I-II molecular integrated high-intermediate or high-risk endometrial carcinoma. The efficacy of chemotherapy vs. chemoradiotherapy is compared in p53 abn subtype and nonendometrioid carcinomas, and vaginal brachytherapy vs. whole pelvic radiotherapy in MMR-D and NSMP molecular subgroups. Patients who consent to follow-up within the trial but not to randomization are treated as recommended in multidisciplinary meetings and enrolled for follow-up only (comprehensive cohort study design). The primary outcome is the 5-year cumulative incidence of disease recurrence. Secondary outcomes are vaginal, pelvic, and distant recurrence rates, 5-year recurrence-free and overall survival, adverse events, and patient-reported symptoms and quality of life. The findings of the trial may eventually help decrease under- and overtreatment and, consequently, improve patient outcome and decrease treatment-associated adverse effects.

注册库
clinicaltrials.gov
开始日期
2022年2月8日
结束日期
2028年12月31日
最后更新
去年
研究类型
Interventional
研究设计
Parallel
性别
Female

研究者

责任方
Principal Investigator
主要研究者

Mikko Loukovaara

Chief of Specialists, MD

University of Helsinki

入排标准

入选标准

  • Age 18 to 100 years
  • WHO performance status 0 to 2
  • Stage I-II molecular integrated high-intermediate or high-risk endometrial carcinoma

排除标准

  • Age \<18 years or \>100 years
  • WHO performance status \>2
  • Uterine sarcoma
  • A history of malignancy within 5 years
  • Previous pelvic radiotherapy
  • An interval of \>30 days between surgery and start of chemotherapy or \>8 weeks between surgery and start of radiotherapy (longer intervals may be permitted with investigator´s approval)

结局指标

主要结局

Cancer reappearance

时间窗: 5 years

Cumulative incidence of disease recurrence

次要结局

  • Location of cancer reappearance(5 years)
  • Overall survival(5 years)
  • Recurrence-free survival(5 years)
  • Adverse events(5 years)

研究点 (1)

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