New shorter radiation may ease side effects for cancer patients
NCT ID NCT07584161
First seen Jun 27, 2026 · Last updated Sep 17, 2026 · Updated 2 times
Summary
This study tests if a newer, shorter course of radiation therapy (MH-ART) is as good as the standard longer course (CF-IMRT) for women who have had surgery for cervical or endometrial cancer. The goal is to see if the new approach causes fewer side effects and improves quality of life. About 228 participants will be randomly assigned to one of the two treatments.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 228 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2025
- Expected to finish
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Sep 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Participants must be fully voluntary and have decision-making capacity, providing written informed consent within 30 days prior to enrollment. 2. Age ≥18 years and ≤75 years. 3. ECOG performance status of 0-1, and expected to tolerate lying supine for half an hour. 4. Have undergone radical surgery for cervical cancer (procedure: radical hysterectomy + pelvic lymphadenectomy ± para-aortic lymphadenectomy) or surgery for endometrial cancer (procedure: total hysterectomy + bilateral salpingo-oophorectomy ± pelvic and/or para-aortic lymph node dissection/sampling or sentinel lymph node biopsy). 5. For participants with cervical cancer, the following criteria must be met: (1)Pathologically diagnosed with cervical squamous cell carcinoma or adenocarcinoma. (2)Must have at least one of the following high-risk factors; or have other risk factors requiring postoperative radiotherapy: High-risk factors: Pelvic lymph node metastasis, or positive surgical margin, or parametrial invasion. Other risk factors: Middle or deep one-third stromal invasion, regardless of tumor size and LVSI status; Tumor size ≥4cm, regardless of depth of stromal invasion and LVSI status; Adenocarcinoma: Tumor size ≥2cm, or positive LVSI, regardless of depth of stromal invasion. 6.For participants with endometrial cancer, the following criteria must be met: Endometrioid adenocarcinoma: Grade 3 with superficial myometrial invasion, accompanied by substantial LVSI or age ≥70 years; Grade 2 with deep myometrial invasion, accompanied by substantial LVSI or age ≥60 years; Grade 3 with deep myometrial invasion; FIGO 2009 Stage II-IIIC1. Non-endometrioid adenocarcinoma: FIGO 2009 Stage I-IIIC1 (serous carcinoma, clear cell carcinoma, mixed type). 7.Participants with high-risk factors may receive a vaginal brachytherapy boost following the completion of external beam radiotherapy. 8.Participants with high-risk cervical cancer must receive concurrent sensitizing chemotherapy for ≥4 cycles. 9.Participants must be eligible to receive sequential or sandwich adjuvant chemotherapy as planned. Exclusion Criteria: 1. Presence of confirmed distant metastasis or para-aortic lymph node metastasis; 2. Requirement for extended-field radiotherapy encompassing the para-aortic region; 3. Initiation of radiotherapy exceeds the specified time limit after surgery: exceeding 6 months post-surgery if adjuvant chemotherapy was administered, or exceeding 3 months post-surgery if no adjuvant chemotherapy was administered; 4. History of previous abdominal or pelvic radiotherapy; 5. History of or concurrent secondary primary malignancy (except for non-melanoma skin cancer, papillary/follicular thyroid carcinoma, or carcinoma in situ of the breast); 6. History of underlying intestinal diseases such as ulcerative colitis or Crohn's disease; 7. Cervical cancer with pathological types such as adenosquamous carcinoma, small cell carcinoma, clear cell carcinoma, or other special types; Endometrial cancer with pathological types such as undifferentiated carcinoma, carcinosarcoma, or other special types; 8. Pregnant or lactating women; 9. Presence of active infection or fever; 10. Other severe comorbidities that may significantly compromise protocol compliance, such as uncontrolled cardiac disease requiring treatment, renal disease, chronic hepatitis, poorly controlled diabetes, psychiatric disorders, etc.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Peking Union Medical College Hospital
RECRUITINGBeijing, Beijing Municipality, 100730, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Shorter, personalized radiation may target endometrial cancer with fewer side effects
- Robotic surgery vs standard approaches: does the platform change cancer outcomes?
- Can a Weight-Loss drug and an IUD treat early uterine cancer without surgery?
- New antibody aims to preserve immune checkpoint while fighting cancer
- Smart speculum could bring cervical cancer screening to remote areas