Adjuvant Radiotherapy in Patients With Early Endometrial Cancer

Not Applicable

Not yet recruiting

• Conditions: Endometrial Cancer; Radiotherapy; Pathology
• Interventions: Radiation: vaginal brachytherapy/pelvic external beam radiotherapy

• Registration Number: NCT04956601
• Lead Sponsor: Peking University Third Hospital

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.

Study Timeline

• Status Verified: 2021-07
• Study Start: 2021-07
• Study First Submitted: 2021-07-02
• Study First Submitted QC: 2021-07-02
• Last Update Submitted: 2021-07-02
• Study First Posted: 2021-07-09
• Last Update Posted: 2021-07-09
• Primary Completion: 2024-08
• Study Completion: 2029-08

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 480

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VBT	vaginal brachytherapy/pelvic external beam radiotherapy	CT image guided high-dose-rate vaginal brachytherapy, 30Gy/6f, 2f/w.
EBRT	vaginal brachytherapy/pelvic external beam radiotherapy	Pelvic external beam radiotherapy，IMRT/VAMT，IGRT suggested，DT 45Gy/25f.

Primary Outcome Measures

Name	Time	Method
DFS	5-year	disease-free survival from being received treatment

Secondary Outcome Measures

Name	Time	Method
Failure mode	5-year	vaginal recurrences; pelvic recurrence; distant metastases
OS	5-year	Overall survival from being received treatment
Toxicities	5-year	from being received treatment

Trial Locations

Locations (1)

Peking University 3rd Hospital; 🇨🇳 Beijing, Beijng, China