Endometrial CancerNCT07116213
Clinical Research on Moderately Hypofractionated Adaptive Postoperative Radiotherapy for High-Risk Endometrial Cancer
A study testing Moderately Hypofractionated Adaptive Radiotherapy in people with Endometrial Cancer and Hypofractionated Dose, run by Xiaorong Hou at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Endometrial Cancer, Hypofractionated Dose, Radiotherapy, Adjuvant
- What is being tested?
- Moderately Hypofractionated Adaptive Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 30 Jun 2025to 30 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Xiaorong Hou, Professor, +86 18612672203, houxr@pumch.cn
About this study
- 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.
Read the detailed description
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.
- Conditions
- Endometrial Cancer, Hypofractionated Dose, Radiotherapy, Adjuvant, Side Effects, Survival , Tumor
- Being tested
- Moderately Hypofractionated Adaptive Radiotherapy
- Keywords
- endometrial cancer, Hypofractionated dose, Radiotherapy
- Medical subject headings
- Endometrial Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderately Hypofractionated Adaptive RadiotherapyRadiation
Moderately Hypofractionated Adaptive Postoperative Radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Moderately Hypofractionated Adaptive Radiotherapy | Experimental | Not described Receives: Radiation: Moderately Hypofractionated Adaptive Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute toxicity
Toxicities occurring <90 days from radiotherapy initiation. Evaluated using CTCAE v5.0.
Measured: <90 days after treatment initiation
Secondary outcomes (4)
3-year failure-free survival
The time from treatment initiation until the occurrence of any treatment failure events.
Measured: From date of surgery to the 3 years after treatment initiation
Chronic Toxicity
Toxicities occurring ≥90 days from radiotherapy initiation. Evaluated using the RTOG Late Morbidity Scoring Schema.
Measured: ≥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.
Measured: From date of surgery to the 3 years after treatment initiation
Treatment Costs
Measured: Through radiotherapy completion, an average of 1 month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start30 Jun 2025
- Primary completion30 Jun 2029 (estimated)
- Study completion30 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiaorong Hou
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xiaorong Hou, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07116213
- Sponsor's protocol ID
- MHART-EC
- Status last verified
- Sep 2026
- First submitted
- 9 Jun 2025
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 Jun 1;8(6):1-9. doi: 10.1001/jamaoncol.2022.0362.
PubMed 35420695Maddah 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.
PubMed 38244105Cho 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.
PubMed 38662364
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Research on Moderately Hypofractionated Adaptive Postoperative Radiotherapy for High-Risk Endometrial Cancer
- ClinicalTrials.gov ID
- NCT07116213
- Acronym / sponsor ID
- MHART-EC
- Conditions
- Endometrial Cancer, Hypofractionated Dose, Radiotherapy, Adjuvant, Side Effects, Survival , Tumor
- Keywords
- endometrial cancer, Hypofractionated dose, Radiotherapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Xiaorong HouUniversity, hospital or other
- Study start
- 30 Jun 2025 (actual)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 30 Dec 2030 (estimated)
- First posted
- 11 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Moderately Hypofractionated Adaptive Radiotherapy | Experimental | Radiation: Moderately Hypofractionated Adaptive Radiotherapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Age : 18-70 years old.
- Performance Status :
- ECOG score 0-2.
- Expected to comply with oART (Online Adaptive Radiotherapy) workflow.
- Initial Surgical Treatment :
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Moderately Hypofractionated Adaptive RadiotherapyModerately Hypofractionated Adaptive Postoperative Radiotherapy | Radiation | Moderately Hypofractionated Adaptive Radiotherapy |
Primary outcome
Acute toxicity
Time frame: <90 days after treatment initiation
Toxicities occurring <90 days from radiotherapy initiation. Evaluated using CTCAE v5.0.
4 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Results publication: PubMed 35420695Leung 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.
- Results publication: PubMed 38244105Maddah 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.
- Results publication: PubMed 38662364Cho 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moderately Hypofractionated Adaptive Radiotherapy in people with Endometrial Cancer and Hypofractionated Dose, run by Xiaorong Hou at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaorong Hou, Professor (+86 18612672203, houxr@pumch.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute toxicity (time frame: <90 days after treatment initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07116213, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.