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

Sponsor
Xiaorong Hou
Study ID
NCT07584161
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Moderately fractionated radiotherapy using online adaptive radiotherapy technology — RADIATION
    Treatment 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. — RADIATION
    Intensity-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.

Study Details

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 Dates

Start date
Jun 1, 2026
Status verified
May 2026
Primary completion
Dec 30, 2027
Completion
Sep 30, 2030

Study Design

Enrollment
228 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: MH-ART
    Moderately fractionated radiotherapy using online adaptive radiotherapy technology.
  • Other: CF-IMRT
    Conventionally fractionated radiotherapy using image-guided intensity-modulated radiotherapy technology.

Primary Outcome Measure

Incidence of Acute Toxicity [ Time Frame: Within 90 days (inclusive) from the start of radiotherapy ]

Central Contacts

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