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NCT07584161Recruiting

MH-ART vs CF-IMRT in Postoperative Cervical/Endometrial Cancer

A Multicenter, Non-Inferiority, Phase III Randomized Controlled Trial Comparing Moderately Hypofractionated Online Adaptive Radiotherapy(MH-ART) vs. Conventional Fractionated Intensity-Modulated Radiotherapy(CF-IMRT) in Postoperative Cervical Cancer and Endometrial Cancer

Source: ClinicalTrials.gov · Last updated 16 Sept 2026

Brief summary (registry, in English)

This is an investigator-initiated, prospective, national multi-center, phase III, randomized, open-label, non-inferiority clinical study. The hypothesis is that using online adaptive radiotherapy technology for moderately fractionated radiotherapy in post-operative patients with cervical/endometrial cancer may reduce radiotherapy-related toxicity and improve quality of life while ensuring target coverage. The objective is to evaluate treatment-related toxicity and efficacy of moderately fractionated online adaptive radiotherapy compared to conventionally fractionated intensity-modulated radiotherapy in post-operative cervical and endometrial cancer patients, aiming to provide a more precise, convenient, and cost-effective treatment option for patients.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
228 (estimated)
First submitted
24 Sept 2025
Start date
25 Sept 2025
Primary completion date
30 Dec 2027
Lead sponsor
Xiaorong Hou
NCT number
NCT07584161

What you commit to

  • Study type: Interventional
  • Planned participants: 228
  • From 25 Sept 2025 to the primary completion date, 30 Dec 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Requirement for extended-field radiotherapy encompassing the para-aortic region;
  • 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;
  • History of previous abdominal or pelvic radiotherapy;
  • History of or concurrent secondary primary malignancy (except for non-melanoma skin cancer, papillary/follicular thyroid carcinoma, or carcinoma in situ of the breast);

Other illness

  • History of underlying intestinal diseases such as ulcerative colitis or Crohn's disease;
  • 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;
  • Presence of active infection or fever;
  • 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.

Other

  • Presence of confirmed distant metastasis or para-aortic lymph node metastasis;
  • Pregnant or lactating women;

Who the study is looking for

  • Participants must be fully voluntary and have decision-making capacity, providing written informed consent within 30 days prior to enrollment.
  • Age ≥18 years and ≤75 years.
  • ECOG performance status of 0-1, and expected to tolerate lying supine for half an hour.
  • 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).
  • 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.

Age in the registry: 18 years to 75 years · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Peking Union Medical College Hospital
Coordinator of this site? Confirm its status
BeijingChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.