MH-ART vs CF-IMRT in Postoperative Cervical/Endometrial Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorXiaorong Hou
About this trial
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.
Eligibility criteria
Qualifiers
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).
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Moderately fractionated radiotherapy using online adaptive radiotherapy technology
- Conventionally fractionated radiotherapy using image-guided intensity-modulated radiotherapy technology.
Treatment groups
228 Participants
are divided into 2 treatment groupsSponsors and collaborators
Xiaorong Hou
Lead sponsor
Peking Union Medical College Hospital
Sponsor institution
Source ClinicalTrials.gov