Back to resultsAdjuvant Radiotherapy in Patients With Early Endometrial Cancer
Primary Purpose
Endometrial Cancer, Pathology, Radiotherapy
Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
vaginal brachytherapy/pelvic external beam radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Endometrial Cancer
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.
Sites / Locations
- Peking University 3rd Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
VBT
EBRT
Arm Description
CT image guided high-dose-rate vaginal brachytherapy, 30Gy/6f, 2f/w.
Pelvic external beam radiotherapy，IMRT/VAMT，IGRT suggested，DT 45Gy/25f.
Outcomes
Primary Outcome Measures
DFS
disease-free survival from being received treatment
Secondary Outcome Measures
Failure mode
vaginal recurrences; pelvic recurrence; distant metastases
OS
Overall survival from being received treatment
Toxicities
from being received treatment
Full Information
NCT ID
NCT04956601
First Posted
July 2, 2021
Last Updated
July 2, 2021
Sponsor
Peking University Third Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04956601
Brief Title
Adjuvant Radiotherapy in Patients With Early Endometrial Cancer
Official Title
A Multicenter, Randomized, Controlled Trial of Adjuvant Radiotherapy in Patients With Early Endometrial Cancer Based on Moderate Risk Molecules Classification
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 2021 (Anticipated)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
August 2029 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University Third Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrial Cancer, Pathology, Radiotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
480 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
VBT
Arm Type
Experimental
Arm Description
CT image guided high-dose-rate vaginal brachytherapy, 30Gy/6f, 2f/w.
Arm Title
EBRT
Arm Type
Active Comparator
Arm Description
Pelvic external beam radiotherapy，IMRT/VAMT，IGRT suggested，DT 45Gy/25f.
Intervention Type
Radiation
Intervention Name(s)
vaginal brachytherapy/pelvic external beam radiotherapy
Other Intervention Name(s)
Pelvic external beam radiotherapy
Intervention Description
high-dose-rate vaginal brachytherapy; pelvic external beam radiotherapy
Primary Outcome Measure Information:
Title
DFS
Description
disease-free survival from being received treatment
Time Frame
5-year
Secondary Outcome Measure Information:
Title
Failure mode
Description
vaginal recurrences; pelvic recurrence; distant metastases
Time Frame
5-year
Title
OS
Description
Overall survival from being received treatment
Time Frame
5-year
Title
Toxicities
Description
from being received treatment
Time Frame
5-year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Junjie Wang
Phone
861082265920
Email
junjiewang_edu@sina.cn
Facility Information:
Facility Name
Peking University 3rd Hospital
City
Beijing
State/Province
Beijng
ZIP/Postal Code
100191
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Adjuvant Radiotherapy in Patients With Early Endometrial Cancer
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