MH-ART vs CF-IMRT in Postoperative Cervical/Endometrial Cancer (NCT07584161) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
MH-ART vs CF-IMRT in Postoperative Cervical/Endometrial Cancer
China228 participantsStarted 2026-06-01
Plain-language summary
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.
Who can participate
Age range18 Years – 75 Years
SexFEMALE
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Inclusion criteria
✓. 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:
✓.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.
✓.Participants with high-risk factors may receive a vaginal brachytherapy boost following the completion of external beam radiotherapy.
What they're measuring
1
Incidence of Acute Toxicity
Timeframe: Within 90 days (inclusive) from the start of radiotherapy
.Participants with high-risk cervical cancer must receive concurrent sensitizing chemotherapy for ≥4 cycles.
Exclusion criteria
✕. 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;