Clinical Research on Moderately Hypofractionated Adaptive Postoperative Radiotherapy for High-Risk Endometrial Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Moderately Hypofractionated Adaptive Radiotherapy.
- Who it may be relevant to
- Registry conditions: Endometrial Cancer, Hypofractionated Dose, Radiotherapy, Adjuvant, Side Effects. Basic parameters: 18 years — 70 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Detailed description
Research Process
1. Baseline Assessment Includes medical history inquiry, physical examination, and relevant laboratory/imaging tests. Complete the pre-radiotherapy Quality of Life Scale. 2. 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.
3\. Follow-up Visits
1. During Radiotherapy: Monitor CBC weekly and Biochemistry Panel every 2 weeks. Perform radiotherapy-related toxicity assessment. 2. 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.
Interventions
- Radiation Moderately Hypofractionated Adaptive Radiotherapy
Moderately Hypofractionated Adaptive Postoperative Radiotherapy
Primary outcome measures
- Acute toxicity [Time frame: <90 days after treatment initiation]
Secondary outcome measures (4)
- 3-year failure-free survival [Time frame: From date of surgery to the 3 years after treatment initiation]
- Chronic Toxicity [Time frame: ≥90 days after treatment initiation]
- Quality of Life (EORTC QLQ-C30/EORTC QLQ-EN24) [Time frame: From date of surgery to the 3 years after treatment initiation]
- Treatment Costs [Time frame: Through radiotherapy completion, an average of 1 month.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Peking Union Medical College Hospital — Beijing
Publications
- 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 PMID 35420695
- 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
- 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
Identifiers
NCT: NCT07116213 · MHART-EC