MH-ART vs CF-IMRT in Postoperative Cervical/Endometrial Cancer
Trial statusRecruiting
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Moderately fractionated radiotherapy using online adaptive radiotherapy technology
RadiationTreatment will be delivered using an online adaptive radiotherapy device. A moderately fractionated regimen will be employed, with a prescribed dose of 40.05 Gy in 15 fractions, administered once daily, five times per week.
Conventionally fractionated radiotherapy using image-guided intensity-modulated radiotherapy technology.
RadiationIntensity-modulated radiotherapy techniques will be used, including FF-IMRT, VMAT, or TOMO. A conventionally fractionated regimen will be employed, with a prescribed dose of 45 Gy in 25 fractions, administered once daily, five times per week.
Treatment groups
228 Participants
are divided into 2 treatment groupsGroup A: MH-ARTExperimental treatment 1 intervention
Group B: CF-IMRTOther 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of Acute Toxicity
Toxicities occurring within 90 days (inclusive) from the start of radiotherapy are defined as acute toxicities. Acute toxicities will be evaluated using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Time frame
Within 90 days (inclusive) from the start of radiotherapySecondary outcomes
1
Incidence of Late Toxicity
Toxicities occurring more than 90 days after the start of radiotherapy are defined as late toxicities. Late toxicities will be evaluated using the RTOG/EORTC Late Radiation Morbidity Scoring Scheme.
Time frame
From 90 days after the start of radiotherapy until death from any cause, assessed up to 3 years.2
3 years Local Recurrence Rate
The proportion of subjects who do not experience tumor recurrence or progression within the radiation field within 3 years after the end of radiotherapy.
Time frame
From the end of radiotherapy until local recurrence or death from any cause, assessed up to 3 years.3
3 years Distant Metastasis Rate
The proportion of subjects who develop distant metastasis within 3 years after the start of radiotherapy.
Time frame
From the start of radiotherapy until distant metastasis or death from any cause, assessed up to 3 years.4
3 years Progression-Free Survival
The time interval from the start of radiotherapy to the first occurrence of disease recurrence (local, regional, or distant) or death from any cause within 3 years after the start of radiotherapy.
Time frame
From the start of radiotherapy until the first disease recurrence (local/regional/distant) or death from any cause, assessed up to 3 years.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Xiaorong Hou
Lead sponsor
Peking Union Medical College Hospital
Sponsor institution
Source ClinicalTrials.gov