Clinical Research on Moderately Hypofractionated Adaptive Postoperative Radiotherapy for High-Risk Endometrial Cancer

NCT07116213 | Recruiting DMC

• 1 other identifier: MHART-EC
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.Study Type: Single-center, single-arm, prospective study.
2. 2.Sample Size: 20 patients with high-risk endometrial cancer were enrolled.
3. 3.Treatment Procedure:
4. 4.Study Endpoints:

Conditions

Endometrial Cancer; Hypofractionated Dose; Radiotherapy, Adjuvant; Side Effects; Survival , Tumor

Keywords

endometrial cancer; Hypofractionated dose; Radiotherapy

Outcome Measures

Primary Outcomes (1)

• Acute toxicity

  Toxicities occurring \<90 days from radiotherapy initiation. Evaluated using CTCAE v5.0.

  <90 days after treatment initiation

Secondary Outcomes (4)

• 3-year failure-free survival

  From date of surgery to the 3 years after treatment initiation

• Chronic Toxicity

  ≥90 days after treatment initiation

• Quality of Life (EORTC QLQ-C30/EORTC QLQ-EN24)

  From date of surgery to the 3 years after treatment initiation

• Treatment Costs

  Through radiotherapy completion, an average of 1 month.

Study Arms (1)

Moderately Hypofractionated Adaptive Radiotherapy

EXPERIMENTAL

Radiation: Moderately Hypofractionated Adaptive Radiotherapy

Interventions

Moderately Hypofractionated Adaptive Radiotherapy RADIATION

Moderately Hypofractionated Adaptive Postoperative Radiotherapy

Moderately Hypofractionated Adaptive Radiotherapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age : 18-70 years old.
• Performance Status :
• ECOG score 0-2.
• Expected to comply with oART (Online Adaptive Radiotherapy) workflow.
• Initial Surgical Treatment :
• Total hysterectomy and bilateral salpingo-oophorectomy ± Pelvic and/or para-aortic lymph node dissection/sampling or sentinel lymph node biopsy.
• Pathological Staging \& Histology (per FIGO 2009):
• Stage I :
• Grade 3 endometrioid adenocarcinoma with superficial myometrial invasion and extensive LVSI (Lymphovascular Space Invasion).
• Grade 2 endometrioid adenocarcinoma with deep myometrial invasion and extensive LVSI.
• Grade 3 endometrioid adenocarcinoma with deep myometrial invasion. Stage II-IIIC1 : Endometrioid carcinoma. Stage I-IIIC1 : Serous carcinoma or clear cell carcinoma.
• Informed Consent :
• Patients and families fully understand the study protocol.
• Voluntarily participate and sign informed consent forms before enrollment

You may not qualify if:

• Prior Radiotherapy : History of abdominal or pelvic irradiation.
• Treatment Interval :
• Without adjuvant chemotherapy: \>12 weeks between surgery and radiotherapy initiation.
• With adjuvant chemotherapy: \>6 months between surgery and radiotherapy initiation.
• Malignancy History : Prior diagnosis of other malignancies.
• Pregnancy/Lactation : Pregnant or breastfeeding women.
• Active Infection : Fever or uncontrolled active infection.
• Inflammatory Bowel Disease (IBD) : History of IBD (regardless of activity status).
• Comorbidities : Severe conditions affecting trial compliance, including: Unstable cardiac disease requiring treatment, renal impairment, chronic hepatitis, poorly controlled diabetes, psychiatric disorders

Sponsors & Collaborators

• Xiaorong Hou: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

Related Publications (3)

• Leung E, Gladwish AP, Davidson M, Taggar A, Velker V, Barnes E, Mendez L, Donovan E, Gien LT, Covens A, Vicus D, Kupets R, MacKay H, Han K, Cheung P, Zhang L, Loblaw A, D'Souza DP. Quality-of-Life Outcomes and Toxic Effects Among Patients With Cancers of the Uterus Treated With Stereotactic Pelvic Adjuvant Radiation Therapy: The SPARTACUS Phase 1/2 Nonrandomized Controlled Trial. JAMA Oncol. 2022 Jun 1;8(6):1-9. doi: 10.1001/jamaoncol.2022.0362.

  PMID: 35420695 BACKGROUND

• Maddah Safaei A, Esmati E, Gomar M, Akhavan S, Sheikh Hasani S, Malekzadeh Moghani M, Zamani N, Moshtaghi M, Malek M, Jafari F, Sharifian A, Kolahdouzan K. Hypofractionated versus standard chemoradiotherapy in the definitive treatment of uterine cervix cancer: interim results of a randomized controlled clinical trial. J Cancer Res Clin Oncol. 2024 Jan 20;150(1):20. doi: 10.1007/s00432-023-05563-8.

  PMID: 38244105 BACKGROUND

• Cho WK, Park W, Kim SW, Lee KK, Ahn KJ, Choi JH. Postoperative Hypofractionated Intensity-Modulated Radiotherapy With Concurrent Chemotherapy in Cervical Cancer: The POHIM-CCRT Nonrandomized Controlled Trial. JAMA Oncol. 2024 Jun 1;10(6):737-743. doi: 10.1001/jamaoncol.2024.0565.

  PMID: 38662364 BACKGROUND

MeSH Terms

Conditions

Endometrial Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Xiaorong Hou, Professor

CONTACT

+86 18612672203; houxr@pumch.cn

Zihan Yan

CONTACT

+8617860628938; yanzihan_zora@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 9, 2025
• First Posted: August 11, 2025
• Study Start: June 30, 2025
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): December 30, 2030
• Last Updated: August 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)