Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT04956601

Adjuvant Radiotherapy in Patients With Early Endometrial Cancer

To compare the effect of vaginal brachytherapy as adjuvant treatment after operation when compared to pelvic external beam radiotherapy in patients with early endometrial cancer based on moderate risk molecules classification.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Endometrial Cancer Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Pathology Radiotherapy Urogenital Diseases Urogenital Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Peking University 3rd Hospital

Beijing, Beijng, 100191, China

About this study

After being informed the study and potential risk，all patients giving written informed consent will be undergo a 1-week screening period determine eligibility for study entry. At week 0, patients who meet the eligibility will be randomized in a 1:1 ratio to vaginal brachytherapy or pelvic external beam radiotherapy. After treatment, patients were followed up regularly.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Endometrial adenocarcinoma is confirmed by pathology, and the molecular types were microsatellite instability type and low copy type;
  • Stage IA and grade 3 or stage IB (FIGO 2009), without substantial lymph-vascular space invasion;
  • Surgery must have included a hysterectomy and bilateral adnexectomy. Pelvic lymph node sampling and para-aortic lymph node sampling are optional;
  • ECOG score is 0-2;
  • The interval time between surgery and radiotherapy is no more than 8 weeks;
  • The routine blood examination was normal;
  • Compliance is good and informed consent is voluntarily signed.

Exclusion criteria

  • The patients receive chemotherapy;
  • History of previous malignant disease;
  • Previous diagnosis of Crohn's disease or ulcerative colitis.

Treatment and study plan

vaginal brachytherapy/pelvic external beam radiotherapy

Radiation

high-dose-rate vaginal brachytherapy; pelvic external beam radiotherapy

Other names: Pelvic external beam radiotherapy

Primary outcomes

  1. DFS

    Time frame: 5-year

    disease-free survival from being received treatment

Secondary outcomes

  1. Failure mode

    Time frame: 5-year

    vaginal recurrences; pelvic recurrence; distant metastases

  2. OS

    Time frame: 5-year

    Overall survival from being received treatment

  3. Toxicities

    Time frame: 5-year

    from being received treatment

Study contacts

Contact information is provided by the study sponsor or research team.

Junjie Wang

CONTACT

[email protected]

861082265920

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Registry information

Official study title

A Multicenter, Randomized, Controlled Trial of Adjuvant Radiotherapy in Patients With Early Endometrial Cancer Based on Moderate Risk Molecules Classification

Important dates

Study start
2021
Primary completion
2024
Study completion
2029
First posted
Jul 9, 2021
Registry last updated
Jul 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.