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Uterine Cervical NeoplasmPhase 2NCT05682950

Optimal Margin Evaluation of Online Adaptive Radiotherapy for Postoperative Treatment of Endometrial and Cervical Cancer

A Phase 2 study testing online adaptive radiotherapy in people with Uterine Cervical Neoplasm and Endometrial Neoplasms, run by Peking Union Medical College Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Online adaptive radiotherapy has demonstrated to be feasible to reduce inter-fractional radiotherapy errors as it re-optimizes treatment plan every fraction. To investigate the extent and value of margin reduction，we conduct a prospective clinical trial to determine the optimal margin and toxicity of smaller margin. Read more about this study

Who is it for?
Ages 18 to 70 years, women only
What is being tested?
online adaptive radiotherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteChina
Study dates
12 Sep 2022to 6 Feb 2025
Phase
Phase 2
Are there results?
None posted in the registry

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 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must be informed of the investigational nature of this study and give written informed consent before treatment.
  • Postoperative endometrial and cervical cancer patients with pathologically confirmed no residual tumor at the resection margin and no evidence of distant metastasis (FIGO stage IVB).
  • Pathological findings indicate risk factors and adjuvant radiotherapy are prescribe.
  • Karnofsky score ≥ 70.
  • Subjects aged ≥ 18 years and ≤ 70 years.
  • No evidence of para-aortic metastatic lymph nodes.
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  • No contraindications to CT scanning.
  • Subjects must be able to cooperate in completing the entire study.
  • Adequate marrow: neutrophile granulocyte count ≥1.5*10^9/L, hemoglobin ≥ 80 g/L, platelet count ≥100*10^9/L.
  • Normal liver and kidney function: Creatinine (Cr) < 1.5 mg/dl, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) < 2*upper limit of normal (ULN).

Who cannot join

  • Subjects who have received prior pelvic radiotherapy.
  • Subjects with other primary malignancies.
  • Subjects with contraindications to radiotherapy, as determined by the investigators.
  • Any severe disease which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control, and emotional disturbance.
  • Active infection with fever.
  • Active inflammatory bowel disease.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100730

Other trials in China

About this study

Official title: A Prospective Study to Evaluate Optimal Margin of Iterative Cone-beam Computed Tomography Guided Online Adaptive Radiotherapy for Postoperative Treatment of Endometrial and Cervical Cancer

Online adaptive radiotherapy has demonstrated to be feasible to reduce inter-fractional radiotherapy errors as it re-optimizes treatment plan every fraction. To investigate the extent and value of margin reduction，we conduct a prospective clinical trial to determine the optimal margin and toxicity of smaller margin.

Read the detailed description

This is a prospective phase II clinical trial with an anticipated total of more than 380 radiotherapy fractions of 15 patients to evaluate optimal margin of iterative cone-beam computed tomography（iCBCT） guided online adaptive radiotherapy （oART） for postoperative treatment of endometrial and cervical cancer. Postoperative endometrial and cervical cancer patients with following characteristics are included in the present study:（a）underwent radical surgery （b）no residual tumor at the resection margin by postoperative pathology（c）pathological findings indicate risk factors but no metastasis (d) adjuvant radiotherapy are prescribe (e)without evidence of para-aortic metastatic lymph nodes. Five patients （almost 125 fractions）treated with oART have the target volume contoured on pre-treatment iCBCTs and end-treatment iCBCTs. Anterior-posterior, lateral, and superior-inferior shifts were calculated and the average shift in all directions was calculated. A clinical target volume (CTV) to planing tumor volume (PTV) expansion is determined and verifies on a validation cohort of 10 patients (almost 250 fractions) treated with oART. Record acute toxicity from the start of treatment to 3 months after treatment.

Being tested
online adaptive radiotherapy
Keywords
Uterine Cervical Neoplasm, Endometrial Neoplasms, Online Adaptive Radiotherapy, Adjuvant Radiotherapy
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.

  • online adaptive radiotherapyRadiation

    CTV covers pelvis.

Study groups in NCT05682950
Study groupRoleWhat they receive
Online Adaptive RadiotherapyExperimentalPatients receive online adaptive radiotherapy. The CTV contours of the following areas: vaginal cuff, obturator nodal chain, internal iliac nodal chain, external iliac nodal chain, presacral nodal chain and common iliac nodal chain. The upper border of CTV is at the level of aortic bifurcation. A dose of 45-50.4Gy is delivered to CTV with online adaptive radiotherapy.
Receives: Radiation: online adaptive radiotherapy

What is being measured

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

  1. The dose coverage of target volume as assessed by planing tumor volume V100%

    Planing tumor volume V100%, defined as the planing tumor volume receiving at least 100% of the prescribed dose (V100%), is used to evaluate the dose coverage of target volume.

    Measured: Through study completion, total an average of six month

  2. A minimum PTV margin could encompass CTV

    Expansions were applied to the pretreatment PTV to assess required minimum margin required to encompass the postreatment CTV.

    Measured: Through study completion, toral an average of six month

Secondary outcomes (6)

  1. Safety for treatment as assessed by organs at risk doses

    Safety for treatment was mainly evaluated by the organs at risk doses, including bladder, rectum, bone marrow, etc

    Measured: Through study completion, total an average of six month

  2. Number of participants with acute toxicity as assessed by CTCAE 5.0

    Evaluated with CTCAE 5.0

    Measured: From the start of treatment to 3 months after treatment

  3. Adaptive time data

    For each treatment in each fraction, adaptive time was recorded from first cone beam computed tomography (CBCT) to the selection of the preferred plan for the treatment.

    Measured: Through study completion, total an average of six month

  4. Target contouring accuracy

    For every target in each fraction, the evaluation of accuracy for target contouring are categorized as follow: no edits, minor edits, moderate edits, major edits and not applicable.

    Measured: Through study completion, total an average of six month

  5. Organs at risk contouring accuracy

    For every organs at risk in each fraction, the evaluation of accuracy for organs at risk contouring are categorized as follows: no edits, minor edits, moderate edits, major edits and not applicable.

    Measured: Through study completion, total an average of six month

  6. Late toxicity evaluated with Radiation Therapy Oncology Group (RTOG)/EORTC late radiation morbidity scoring scheme

    Evaluated every three months with Radiation Therapy Oncology Group (RTOG)/EORTC late radiation morbidity scoring scheme

    Measured: total an average of 2-year

Timeline

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

  1. First posted12 Jan 2023
  2. Study start12 Sep 2022
  3. Primary completion6 Feb 2023
  4. Study completion6 Feb 2025

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05682950
Sponsor's protocol ID
pumch-ART
Status last verified
May 2026
First submitted
14 Dec 2022
Last updated
8 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • de Jong R, Visser J, van Wieringen N, Wiersma J, Geijsen D, Bel A. Feasibility of Conebeam CT-based online adaptive radiotherapy for neoadjuvant treatment of rectal cancer. Radiat Oncol. 2021 Jul 23;16(1):136. doi: 10.1186/s13014-021-01866-7.

    PubMed 34301300

  • Schiff JP, Stowe HB, Price A, Laugeman E, Hatscher C, Hugo GD, Badiyan SN, Kim H, Robinson CG, Henke LE. In Silico Trial of Computed Tomography-Guided Stereotactic Adaptive Radiation Therapy (CT-STAR) for the Treatment of Abdominal Oligometastases. Int J Radiat Oncol Biol Phys. 2022 Dec 1;114(5):1022-1031. doi: 10.1016/j.ijrobp.2022.06.078. Epub 2022 Jun 26.

    PubMed 35768023

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing online adaptive radiotherapy in people with Uterine Cervical Neoplasm and Endometrial Neoplasms, run by Peking Union Medical College Hospital 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 10 inclusion and 6 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: finished, as of the sponsor's last update on 8 Jun 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The dose coverage of target volume as assessed by planing tumor volume V100% (time frame: Through study completion, total an average of six month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05682950, which also lists 2 linked publications.

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 8 Jun 2026.

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