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Not yet recruiting NCT04956601

Adjuvant Radiotherapy in Patients With Early Endometrial Cancer

No phase Interventional Endometrial Cancer Pathology Radiotherapy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: vaginal brachytherapy/pelvic external beam radiotherapy.
Who it may be relevant to
Registry conditions: Endometrial Cancer, Pathology, Radiotherapy. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Detailed description

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.

Interventions

  • Radiation vaginal brachytherapy/pelvic external beam radiotherapy
    high-dose-rate vaginal brachytherapy; pelvic external beam radiotherapy

Primary outcome measures

  • DFS [Time frame: 5-year]
Secondary outcome measures (3)
  • Failure mode [Time frame: 5-year]
  • OS [Time frame: 5-year]
  • Toxicities [Time frame: 5-year]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Peking University 3rd Hospital — Beijing

Identifiers

NCT: NCT04956601 · ECART001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗