Study of Moderately Hypofractionated Adaptive Postoperative Radiotherapy
for Women With High-Risk Endometrial Cancer
Led by Xiaorong Hou · Updated on 2025-08-11
20
Participants Needed
1
Research Sites
78 weeks
Total Duration
AI-Summary
What this Trial Is About
This research investigates moderately hypofractionated adaptive postoperative radiotherapy for women with high-risk endometrial cancer. The study is a single-center, single-arm, prospective trial enrolling 20 patients. The goal is to evaluate treatment safety by measuring acute toxicity and to assess longer-term outcomes such as 3-year failure-free survival, chronic toxicity, quality of life, and treatment costs.
Participants receive external beam radiation therapy EBRT using an online adaptive radiotherapy technology targeting the vagina and pelvic lymph nodes. The EBRT dose is 40.05 Gy given over 15 fractions, once daily, five days a week. After EBRT, 3D intracavitary brachytherapy is delivered in 2-3 fractions of 4-6 Gy each, spaced 1-2 days apart. Radiotherapy can be combined with chemotherapy, administered during chemotherapy intervals or after its completion.
During treatment, patients undergo weekly blood counts, biochemistry tests every two weeks, and toxicity assessments. Follow-up visits occur at treatment end, 3 months, 6 months, and every 6 months up to 3 years, including medical exams, quality of life assessments, and laboratoryimaging tests. The primary outcome is acute toxicity within 90 days of treatment start, while secondary outcomes include longer-term survival, chronic toxicity, quality of life measures, and treatment costs.
CONDITIONS
Brief Title
Clinical Research on Moderately Hypofractionated Adaptive Postoperative Radiotherapy for High-Risk Endometrial Cancer
Research Team
X
Xiaorong Hou, Professor
Z
Zihan Yan
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Able to comply with online adaptive radiotherapy workflow
Have had total hysterectomy and bilateral salpingo-oophorectomy with or without pelvic and/or para-aortic lymph node dissection, sampling, or sentinel lymph node biopsy
Pathological staging and histology per FIGO 2009 including specific grades and stages of endometrioid, serous, or clear cell carcinoma
Patients and families understand the study and voluntarily sign informed consent
You will not qualify if you...
History of abdominal or pelvic radiotherapy
More than 12 weeks between surgery and radiotherapy if no chemotherapy
More than 6 months between surgery and radiotherapy if chemotherapy given
Prior diagnosis of other malignancies
Pregnant or breastfeeding women
Fever or uncontrolled active infection
History of inflammatory bowel disease
Severe comorbidities affecting participation such as unstable cardiac disease, renal impairment, chronic hepatitis, poorly controlled diabetes, or psychiatric disorders
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Approximately 1 month
Participants receive moderately hypofractionated adaptive postoperative radiotherapy including External Beam Radiotherapy followed by 3D intracavitary brachytherapy.
Daily visits 5 times per week during External Beam Radiotherapy and 2 to 3 visits for brachytherapy with 1 to 2 day intervals
Follow-up
Duration - Up to 3 years post-radiotherapy
Participants are monitored through medical history inquiry, physical examination, quality of life assessments, and laboratory/imaging tests to assess treatment effects and toxicity.
Weekly visits during radiotherapy for blood tests; follow-up visits at end of radiotherapy, 3 months, 6 months, then every 6 months thereafter
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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Published Research Related To This Trial
Hypofractionated versus standard chemoradiotherapy in the definitive treatment of uterine cervix cancer: interim results of a randomized controlled clinical trial.
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.
Postoperative Hypofractionated Intensity-Modulated Radiotherapy With Concurrent Chemotherapy in Cervical Cancer: The POHIM-CCRT Nonrandomized Controlled Trial.