Adjuvant Radiotherapy in Patients With Early Endometrial Cancer

Endometrial Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04956601
• Other study ID #: ECART001
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2021
• Est. completion date: August 2029

Study information

• Verified date: July 2021
• Source: Peking University Third Hospital
• Contact: Junjie Wang
• Phone: 861082265920
• Email: junjiewang_edu[@]sina.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 480
• Est. completion date: August 2029
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Endometrial Cancer
• Endometrial Neoplasms
• Pathology
• Radiotherapy

Intervention

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

Locations

Country	Name	City	State
China	Peking University 3rd Hospital	Beijing	Beijng

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DFS	disease-free survival from being received treatment	5-year
Secondary	Failure mode	vaginal recurrences; pelvic recurrence; distant metastases	5-year
Secondary	OS	Overall survival from being received treatment	5-year
Secondary	Toxicities	from being received treatment	5-year