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Active, not recruitingNCT05869123Updated Jun 8, 2026

Online Adaptive Radiotherapy for Postoperative Treatment of Endometrial and Cervical Cancer

A Phase 1/2 interventional study of Online adaptive radiotherapy in Uterine Cervical Neoplasm and Endometrial Neoplasms, sponsored by Peking Union Medical College Hospital. Active, not recruiting at 1 site in China. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-06-08.

Sponsored by Peking Union Medical College Hospital · Phase 1/2, Interventional, and Treatment

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Oct 2022, registered May 2023).
Phase
Phase 1/2
Study type
Interventional
Enrollment
17
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
Female
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Study summary

Online adaptive radiotherapy (oART) has demonstrated to be feasible to reduce planning target volume (PTV) margins for postoperative treatment of endometrial and cervical cancer. To explore the value of reduced margins in oART for postoperative treatment of endometrial and cervical cancer, we conducted a prospective clinical trial to determine the clinical efficacy and toxicity of reduced margins.

Read the detailed description

This is an investigator-initiated efficacious, single-center, open-label clinical trial study. This study hypothesizes that the use of reduced PTV margins in oART for postoperative treatment of endometrial and cervical cancer could decrease toxicity and achieve more accurate dosimetric coverage. A dose of 45 or 50.4 Gy is delivered to clinical target volume (CTV) with reduced margin oART. Patients receive cisplatin based concurrent chemotherapy. The primary endpoint is acute toxicity. The first 10 patients were included in the study that have demonstrated the feasibility of reducing the margin (ClinicalTrials.gov ID: NCT05682950).

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Conditions studied

  • Uterine Cervical Neoplasm
  • Endometrial Neoplasms

Keywords

  • Uterine Cervical Neoplasm
  • Endometrial Neoplasms
  • Online Adaptive Radiotherapy
  • Adjuvant Radiotherapy
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In context

Uterine Cervical Neoplasms

1,881 studies on the registry are indexed under Uterine Cervical Neoplasms; 567 are open to participants now.

This study's enrollment of 17 is below the median of 100 across 1,377 interventional studies indexed under Uterine Cervical Neoplasms.

Browse Uterine Cervical Neoplasms studies →

Lead sponsor

Peking Union Medical College Hospital is the lead sponsor of 1,115 studies on the registry; 463 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  1. Patients must be informed of the investigational nature of this study and give written informed consent before treatment.
  2. 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).
  3. Pathological findings indicate risk factors and adjuvant radiotherapy are prescribe.
  4. Karnofsky score ≥ 70.
  5. Subjects aged ≥ 18 years and ≤ 70 years.
  6. No evidence of para-aortic metastatic lymph nodes.
  7. No contraindications to CT scanning.
  8. Subjects must be able to cooperate in completing the entire study.
  9. Adequate marrow: neutrophile granulocyte count ≥1.5*10\^9/L, hemoglobin ≥ 80 g/L, platelet count ≥100*10\^9/L.
  10. Normal liver and kidney function: Creatinine (Cr) \< 1.5 mg/dl, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) \< 2*upper limit of normal (ULN).

Exclusion criteria

Exclusion Criteria:

  1. Subjects who have received prior pelvic radiotherapy.
  2. Subjects with other primary malignancies.
  3. Subjects with contraindications to radiotherapy, as determined by the investigators.
  4. 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.
  5. Active infection with fever.
  6. Active inflammatory bowel disease.
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Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
17 participants (actual)

Study arms

  • Experimental
    Online Adaptive Radiotherapy

    Patients receive online adaptive radiotherapy with 5mm PTV margin. The CTV-N covered pelvic lymph nodes (common, internal and external iliac, obturator, and presacral) and CTV-V covered proximal vagina and any paravaginal or retracted parametrial tissue. A dose of 45 or 50.4Gy is delivered to CTV with online adaptive radiotherapy.

    Radiation: Online adaptive radiotherapy

Interventions

  • RadiationOnline adaptive radiotherapy

    PTV with 5 margins covers CTV

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What researchers measure

Primary outcomes

  1. Physician-reported acute toxicity

    Physician-reported acute toxicity evaluated with Common Terminology Criteria for Adverse Events (CTCAE) 5.0

    Time frame: From the start of treatment to 3 months after treatment

Secondary outcomes

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

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

    Time frame: 3-year

  2. 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.

    Time frame: Through study completion, an average of five month

  3. Target automatically 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.

    Time frame: Through study completion, an average of five month

  4. 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.

    Time frame: Through study completion, an average of five month

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Study locations

1 site
  • Peking Union Medical College Hospital
    Beijing, Beijing Municipality 100730, China
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References and documents

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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05869123
Lead sponsor
Peking Union Medical College Hospital
Responsible party
Sponsor
First posted
May 22, 2023
Start date
Oct 20, 2022
Primary completion
Mar 3, 2023
Completion
Sep 3, 2026 (estimated)
Last update
Jun 8, 2026

Study contacts

Fuquan Zhang, M.D.
study chair · Peking Union Medical College Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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