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NCT Number: NCT07116213

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

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

The existing clinical oART (Online Adaptive Radiotherapy) workflow protocol for malignant tumors used in our department was applied.

Procedures included simulation, target volume delineation, radiotherapy planning, and treatment delivery.

External beam radiation therapy (EBRT) was delivered using moderate hypofractionation.

If indicated, brachytherapy was performed after the completion of EBRT. When combined with chemotherapy, radiotherapy could be administered during chemotherapy intervals or after completion of chemotherapy. 4. Study Endpoints:

Primary Endpoint: Incidence of acute toxicity. Secondary Endpoints: 3-year failure-free survival (FFS) rate, incidence of chronic toxicity, quality of life (QoL), treatment costs, etc.

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Key information

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location status: Recruiting

Location contact

Xiaorong Hou, Professor

CONTACT

[email protected]

+86 18612672203

About this study

Research Process

  • Baseline Assessment Includes medical history inquiry, physical examination, and relevant laboratory/imaging tests. Complete the pre-radiotherapy Quality of Life Scale.
  • Treatment Plan

External Beam Radiotherapy (EBRT): Utilize online adaptive radiotherapy technology to irradiate the vagina and pelvic lymph node drainage areas. Employ moderate fractionation. Prescription Dose: 40.05 Gy / 15 fractions, administered once daily, five times per week.

Brachytherapy: Commence after completion of EBRT. Utilize 3D intracavitary brachytherapy technology. Fraction Dose: 4-6 Gy, for a total of 2-3 fractions, administered with an interval of 1-2 days between fractions.

  • Follow-up Visits
  • During Radiotherapy: Monitor CBC weekly and Biochemistry Panel every 2 weeks. Perform radiotherapy-related toxicity assessment.
  • Post-Radiotherapy:

Timepoints: End of radiotherapy; 3 months post-radiotherapy; 6 months post-radiotherapy; then every 6 months thereafter, until 3 years post-radiotherapy.

Follow-up Content: Includes medical history inquiry, physical examination, and Quality of Life assessment; Laboratory/Imaging Tests.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Moderately Hypofractionated Adaptive Radiotherapy

Radiation

Moderately Hypofractionated Adaptive Postoperative Radiotherapy

Primary outcomes

  1. Acute toxicity

    Time frame: <90 days after treatment initiation

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

Secondary outcomes

  1. 3-year failure-free survival

    Time frame: From date of surgery to the 3 years after treatment initiation

    The time from treatment initiation until the occurrence of any treatment failure events.

  2. Chronic Toxicity

    Time frame: ≥90 days after treatment initiation

    Toxicities occurring ≥90 days from radiotherapy initiation. Evaluated using the RTOG Late Morbidity Scoring Schema.

  3. Quality of Life (EORTC QLQ-C30/EORTC QLQ-EN24)

    Time frame: From date of surgery to the 3 years after treatment initiation

    EORTC QLQ-C30: This is a core quality of life questionnaire developed by the EORTC, applicable to all cancer patients. Scores are standardized to a 0-100 scale. For functional scales and the global quality of life scale, higher scores indicate better functioning or quality of life. For symptom scales/single items, higher scores indicate more severe symptoms or problems.

    EORTC QLQ-EN24: This is a module specifically designed to assess symptoms and quality of life unique to endometrial cancer patients. It serves as a supplementary module to the QLQ-C30 and cannot be analyzed independently. Scores are standardized to a 0-100 scale. For symptom items, higher scores indicate a greater symptom burden. For function/satisfaction items, higher scores indicate better function or satisfaction.

  4. Treatment Costs

    Time frame: Through radiotherapy completion, an average of 1 month.

Study contacts

Contact information is provided by the study sponsor or research team.

Xiaorong Hou, Professor

CONTACT

[email protected]

+86 18612672203

Zihan Yan

CONTACT

[email protected]

+8617860628938

Sponsors and collaborators

Lead sponsor

Xiaorong Hou

Other

Registry information

Important dates

Study start
2025
Primary completion
2029
Study completion
2030
First posted
Aug 11, 2025
Registry last updated
Aug 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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