Adjuvant Radiotherapy in Patients With Early Endometrial Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorPeking University Third Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
The patients receive chemotherapy;
History of previous malignant disease;
Previous diagnosis of Crohn's disease or ulcerative colitis.
Trial design
Design model
Parallel
Treatments tested in this trial
vaginal brachytherapy/pelvic external beam radiotherapy
Radiationhigh-dose-rate vaginal brachytherapy; pelvic external beam radiotherapy
Treatment groups
480 Participants
are divided into 2 treatment groupsGroup A: VBTExperimental treatment 1 intervention
Group B: EBRTActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
DFS
disease-free survival from being received treatment
Time frame
5-yearSecondary outcomes
1
Failure mode
vaginal recurrences; pelvic recurrence; distant metastases
Time frame
5-year2
OS
Overall survival from being received treatment
Time frame
5-year3
Toxicities
from being received treatment
Time frame
5-yearSponsors and contacts
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Source ClinicalTrials.gov
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