Adjuvant Radiotherapy in Patients With Early Endometrial Cancer

NCT04956601 | Not Yet Recruiting

• 1 other identifier: ECART001
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometrial Cancer; Pathology; Radiotherapy

Outcome Measures

Primary Outcomes (1)

• DFS

  disease-free survival from being received treatment

  5-year

Secondary Outcomes (3)

• Failure mode

  5-year

• OS

  5-year

• Toxicities

  5-year

Study Arms (2)

VBT

EXPERIMENTAL

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

Radiation: vaginal brachytherapy/pelvic external beam radiotherapy

EBRT

ACTIVE COMPARATOR

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

Radiation: vaginal brachytherapy/pelvic external beam radiotherapy

Interventions

vaginal brachytherapy/pelvic external beam radiotherapy RADIATION

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

Also known as: Pelvic external beam radiotherapy

EBRT; VBT

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• The interval time between surgery and radiotherapy is no more than 8 weeks;
• The routine blood examination was normal;
• Compliance is good and informed consent is voluntarily signed.

You may not qualify if:

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

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University 3rd Hospital

Beijing, Beijng, 100191, China

Location

MeSH Terms

Conditions

Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Central Study Contacts

Junjie Wang

CONTACT

861082265920; junjiewang_edu@sina.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Peking University Third Hospital

Study Record Dates

• First Submitted: July 2, 2021
• First Posted: July 9, 2021
• Study Start: July 1, 2021
• Primary Completion: August 1, 2024
• Study Completion (Estimated): August 1, 2029
• Last Updated: July 9, 2021

Record last verified: 2021-07

Locations

CN (1)