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Cervical CancerARTISANNCT07584161

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

A study testing Moderately fractionated radiotherapy using online adaptive radiotherapy technology and Conventionally fractionated radiotherapy using image-guided intensity-modulated radiotherapy technology. in people with Cervical Cancer and Endometrial Cancer, run by Xiaorong Hou at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 years, women only
Conditions the study is for
Cervical Cancer, Endometrial Cancer
What is being tested?
Moderately fractionated radiotherapy using online adaptive radiotherapy technology and Conventionally fractionated radiotherapy using image-guided intensity-modulated radiotherapy technology.
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
228 participants
Where
1 siteChina
Study dates
25 Sep 2025to 30 Sep 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • (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.
  • 6.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).
  • 7.Participants with high-risk factors may receive a vaginal brachytherapy boost following the completion of external beam radiotherapy.
  • 8.Participants with high-risk cervical cancer must receive concurrent sensitizing chemotherapy for ≥4 cycles.
  • 9.Participants must be eligible to receive sequential or sandwich adjuvant chemotherapy as planned.

Who cannot join

  • 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;
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  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Xiaorong Hou, Professor contact

+86 18612672203

houxr@pumch.cn

China1 site, 1 recruiting
  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100730

    Xiaorong Hou, Professor, +86 18612672203, houxr@pumch.cn

    Zihan Yan, +86 17860628938, yanzihan_zora@163.com

    Recruiting

Other trials in China

About this study

Official title: A Multicenter, Non-Inferiority, Phase III Randomized Controlled Trial Comparing Moderately Hypofractionated Online Adaptive Radiotherapy(MH-ART) vs. Conventional Fractionated Intensity-Modulated Radiotherapy(CF-IMRT) in Postoperative Cervical Cancer and Endometrial Cancer

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.

Read the detailed description

Randomization:

Intervention Group: Moderately fractionated radiotherapy using online adaptive radiotherapy technology.

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

Stratification Factors for Randomization:Participating study center; Disease type (Cervical cancer / Endometrial cancer); Receipt of concurrent chemotherapy

Study Objectives:

Primary Endpoint: Acute adverse reactions/toxicity Secondary Endpoints: Late adverse reactions/toxicity, 3-year local control rate, 3-year distant metastasis rate, 3-year progression-free survival (PFS), 3-year overall survival (OS), 3-year disease-free survival (DFS), quality of life, cost-effectiveness analysis related to treatment.

Study Population:

Planned Sample Size: 228 participants

Inclusion Criteria:

  1. Participants must be fully voluntary and have decision-making capacity, providing written informed consent within 30 days prior to enrollment.
  2. Age ≥18 years and ≤75 years.
  3. ECOG performance status of 0-1, and expected to tolerate lying supine for half an hour.
  4. 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).
  5. 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.

6.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).

7.Participants with high-risk factors may receive a vaginal brachytherapy boost following the completion of external beam radiotherapy.

8.Participants with high-risk cervical cancer must receive concurrent sensitizing chemotherapy for ≥4 cycles.

9.Participants must be eligible to receive sequential or sandwich adjuvant chemotherapy as planned.

Study Duration: September 2025 to September 2030 Participant Involvement Period: Follow-up for over 3 years after radiotherapy

Being tested
Moderately fractionated radiotherapy using online adaptive radiotherapy technology, Conventionally fractionated radiotherapy using image-guided intensity-modulated radiotherapy technology.
Keywords
Cervical cancer, Endometrial cancer, Moderately fractionated radiotherapy, Acute adverse reactions
Medical subject headings
Uterine Cervical Neoplasms, Endometrial Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • 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 groups in NCT07584161
Study groupRoleWhat they receive
MH-ARTExperimentalModerately fractionated radiotherapy using online adaptive radiotherapy technology.
Receives: Radiation: Moderately fractionated radiotherapy using online adaptive radiotherapy technology
CF-IMRTOtherConventionally fractionated radiotherapy using image-guided intensity-modulated radiotherapy technology.
Receives: Radiation: Conventionally fractionated radiotherapy using image-guided intensity-modulated radiotherapy technology.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Within 90 days (inclusive) from the start of radiotherapy

Secondary outcomes (8)
  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

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

  5. 3 years Overall Survival

    The time interval from the start of radiotherapy to death from any cause within 3 years after the start of radiotherapy.

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

  6. 3 years Disease-Free Survival

    The time interval from the start of radiotherapy to the first occurrence of local or regional recurrence, distant metastasis, or death from any cause within 3 years after the start of radiotherapy.

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

  7. Quality of Life

    Quality of life will be assessed using the QLQ-C30 questionnaire, in combination with the disease-specific module (QLQ-CX24 for cervical cancer; QLQ-EN24 for endometrial cancer).

    Measured: Baseline, at the end of radiotherapy, and every 3 months thereafter until 3 years from start of radiotherapy.

  8. Treatment-Related Cost-Effectiveness Analysis

    The cost assessment should cover both medical costs and non-medical costs.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 May 2026
  2. Study start25 Sep 2025
  3. Primary completion30 Dec 2027 (estimated)
  4. Study completion30 Sep 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Intervention Group: Moderately fractionated radiotherapy using online adaptive radiotherapy technology.
Masking
None (open label)
Enrolment
228 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07584161
Sponsor's protocol ID
ARTISAN
Acronym
ARTISAN
Status last verified
Sep 2026
First submitted
24 Sep 2025
Last updated
16 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Moderately fractionated radiotherapy using online adaptive radiotherapy technology and Conventionally fractionated radiotherapy using image-guided intensity-modulated radiotherapy technology. in people with Cervical Cancer and Endometrial Cancer, run by Xiaorong Hou at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Xiaorong Hou, Professor (+86 18612672203, houxr@pumch.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Acute Toxicity (time frame: Within 90 days (inclusive) from the start of radiotherapy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.

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