NCT07584161

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
228

participants targeted

Target at P75+ for not_applicable

Timeline
53mo left

Started Jun 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 24, 2025

Completed
8 months until next milestone

First Posted

Study publicly available on registry

May 13, 2026

Completed
19 days until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2027

2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2030

Last Updated

May 13, 2026

Status Verified

May 1, 2026

Enrollment Period

1.6 years

First QC Date

September 24, 2025

Last Update Submit

May 6, 2026

Conditions

Cervical CancerEndometrial Cancer

Keywords

Cervical cancerEndometrial cancerModerately fractionated radiotherapyAcute adverse reactions

Outcome Measures

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.

    Within 90 days (inclusive) from the start of radiotherapy

Secondary Outcomes (8)

  • Incidence of Late Toxicity

    From 90 days after the start of radiotherapy until death from any cause, assessed up to 3 years.

  • 3 years Local Recurrence Rate

    From the end of radiotherapy until local recurrence or death from any cause, assessed up to 3 years.

  • 3 years Distant Metastasis Rate

    From the start of radiotherapy until distant metastasis or death from any cause, assessed up to 3 years.

  • 3 years Progression-Free Survival

    From the start of radiotherapy until the first disease recurrence (local/regional/distant) or death from any cause, assessed up to 3 years.

  • 3 years Overall Survival

    From the start of radiotherapy until death from any cause, assessed up to 3 years.

  • +3 more secondary outcomes

Study Arms (2)

MH-ART

EXPERIMENTAL

Moderately fractionated radiotherapy using online adaptive radiotherapy technology.

Radiation: Moderately fractionated radiotherapy using online adaptive radiotherapy technology

CF-IMRT

OTHER

Conventionally fractionated radiotherapy using image-guided intensity-modulated radiotherapy technology.

Radiation: Conventionally fractionated radiotherapy using image-guided intensity-modulated radiotherapy technology.

Interventions

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.

CF-IMRT
Moderately fractionated radiotherapy using online adaptive radiotherapy technologyRADIATION

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.

MH-ART

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

MeSH Terms

Conditions

Uterine Cervical NeoplasmsEndometrial Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Central Study Contacts

Xiaorong Hou, Professor

CONTACT

+86 18612672203houxr@pumch.cn

Zihan Yan

CONTACT

+86 17860628938yanzihan_zora@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Intervention Group: Moderately fractionated radiotherapy using online adaptive radiotherapy technology.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 24, 2025

First Posted

May 13, 2026

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

December 30, 2027

Study Completion (Estimated)

September 30, 2030

Last Updated

May 13, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)