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Study Type: Single-center, single-arm, prospective study.
Sample Size: 20 patients with high-risk endometrial cancer were enrolled.
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.
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.
Research Process
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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Moderately Hypofractionated Adaptive Radiotherapy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Moderately Hypofractionated Adaptive Radiotherapy | Radiation | Moderately Hypofractionated Adaptive Postoperative Radiotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Acute toxicity | Toxicities occurring <90 days from radiotherapy initiation. Evaluated using CTCAE v5.0. | <90 days after treatment initiation |
| Measure | Description | Time Frame |
|---|---|---|
| 3-year failure-free survival | The time from treatment initiation until the occurrence of any treatment failure events. | From date of surgery to the 3 years after treatment initiation |
| Chronic Toxicity |
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Inclusion Criteria:
ECOG score 0-2.
Total hysterectomy and bilateral salpingo-oophorectomy ± Pelvic and/or para-aortic lymph node dissection/sampling or sentinel lymph node biopsy.
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.
Exclusion Criteria:
Without adjuvant chemotherapy: >12 weeks between surgery and radiotherapy initiation.
With adjuvant chemotherapy: >6 months between surgery and radiotherapy initiation.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaorong Hou, Professor | Contact | +86 18612672203 | houxr@pumch.cn | |
| Zihan Yan | Contact | +8617860628938 | yanzihan_zora@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Recruiting | Beijing | Beijing Municipality | 100730 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35420695 | Result | 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. | |
| 38244105 |
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Toxicities occurring ≥90 days from radiotherapy initiation. Evaluated using the RTOG Late Morbidity Scoring Schema.
| ≥90 days after treatment initiation |
| Quality of Life (EORTC QLQ-C30/EORTC QLQ-EN24) | 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. | From date of surgery to the 3 years after treatment initiation |
| Treatment Costs | Through radiotherapy completion, an average of 1 month. |
| Result |
| 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. |
| 38662364 | Result | 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. |
| ID | Term |
|---|---|
| D016889 | Endometrial Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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