Adjuvant Radiotherapy in Patients With Early Endometrial Cancer

Peking University

Status: Not yet enrolling

Conditions: Endometrial Cancer; Radiotherapy; Pathology

Treatments: Radiation: vaginal brachytherapy/pelvic external beam radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04956601

ECART001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 480 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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480 participants in 2 patient groups

VBT

Experimental group

Description:

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

Treatment:

Radiation: vaginal brachytherapy/pelvic external beam radiotherapy

EBRT

Active Comparator group

Description:

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

Treatment:

Radiation: vaginal brachytherapy/pelvic external beam radiotherapy