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

Starting soon · Not applicable

Conditions studied: Cervical Cancer, Endometrial Cancer

In brief

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.

Key facts

Study ID

NCT07584161

Run by

Xiaorong Hou

People needed

228

Starts

2026-06-01

Expected to finish

2030-09-30

Last updated by the study team

2026-05-13

Who can join

Age: 18 and older, up to 75. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• 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).
• Participants with high-risk factors may receive a vaginal brachytherapy boost following the completion of external beam radiotherapy.
• Participants with high-risk cervical cancer must receive concurrent sensitizing chemotherapy for ≥4 cycles.
• Participants must be eligible to receive sequential or sandwich adjuvant chemotherapy as planned.

You may not qualify if…

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

Where it is running

• Peking Union Medical College Hospital — Beijing, Beijing Municipality, China

Full record on ClinicalTrials.gov

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