Adjuvant Radiotherapy in Patients With Early Endometrial Cancer

July 2, 2021 updated by: Junjie Wang, Peking University Third Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

480

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijng
      • Beijing, Beijng, China, 100191
        • Peking University 3rd Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: VBT
CT image guided high-dose-rate vaginal brachytherapy, 30Gy/6f, 2f/w.
Radiation: vaginal brachytherapy/pelvic external beam radiotherapy
high-dose-rate vaginal brachytherapy; pelvic external beam radiotherapy
Other Names:
  • Pelvic external beam radiotherapy
Active Comparator: EBRT
Pelvic external beam radiotherapy，IMRT/VAMT，IGRT suggested，DT 45Gy/25f.
Radiation: vaginal brachytherapy/pelvic external beam radiotherapy
high-dose-rate vaginal brachytherapy; pelvic external beam radiotherapy
Other Names:
  • Pelvic external beam radiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DFS
Time Frame: 5-year
disease-free survival from being received treatment
5-year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Failure mode
Time Frame: 5-year
vaginal recurrences; pelvic recurrence; distant metastases
5-year
OS
Time Frame: 5-year
Overall survival from being received treatment
5-year
Toxicities
Time Frame: 5-year
from being received treatment
5-year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University Third Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 1, 2021

Primary Completion (Anticipated)

August 1, 2024

Study Completion (Anticipated)

August 1, 2029

Study Registration Dates

First Submitted

July 2, 2021

First Submitted That Met QC Criteria

July 2, 2021

First Posted (Actual)

July 9, 2021

Study Record Updates

Last Update Posted (Actual)

July 9, 2021

Last Update Submitted That Met QC Criteria

July 2, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ECART001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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