Adjuvant Radiotherapy in Patients With Early Endometrial Cancer

NCT ID: NCT04956601

Last Updated: 2021-07-09

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 480 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-31
• Study Completion Date: 2029-08-31

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.

Conditions

Endometrial Cancer; Pathology; Radiotherapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

VBT

CT image guided high-dose-rate vaginal brachytherapy, 30Gy/6f, 2f/w.

Group Type: EXPERIMENTAL

vaginal brachytherapy/pelvic external beam radiotherapy

Intervention Type: RADIATION

high-dose-rate vaginal brachytherapy; pelvic external beam radiotherapy

EBRT

Pelvic external beam radiotherapy，IMRT/VAMT，IGRT suggested，DT 45Gy/25f.

Group Type: ACTIVE_COMPARATOR

vaginal brachytherapy/pelvic external beam radiotherapy

Intervention Type: RADIATION

high-dose-rate vaginal brachytherapy; pelvic external beam radiotherapy

Interventions

vaginal brachytherapy/pelvic external beam radiotherapy

high-dose-rate vaginal brachytherapy; pelvic external beam radiotherapy

Intervention Type: RADIATION

Other Intervention Names

Pelvic external beam radiotherapy

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Peking University Third Hospital

OTHER

Sponsor Role: lead

Responsible Party

Junjie Wang

Peking University Third Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Peking University 3rd Hospital

Beijing, Beijng, China

Countries

China

Central Contacts

Junjie Wang

Role: CONTACT

junjiewang_edu@sina.cn

861082265920

Other Identifiers

ECART001

Identifier Type: -

Identifier Source: org_study_id