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NCT Number: NCT05880485

Online Adaptive Radiotherapy Cervical Cancer With Reduced Margin for Cervical Cancer

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

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Uterine Cervical Neoplasm Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

About this study

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 cervical cancer could decrease toxicity and achieve more accurate dosimetric coverage. A dose of 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients must be informed of the investigational nature of this study and give written informed consent before treatment.
  • Age ≥18 years and ≤ 75 years.
  • Patients with newly histologically confirmed cervical cancer, including squamous cell carcinoma, adenocarcinoma and adenosquamous carcinoma, et al.
  • No evidence of para-aortic metastatic lymph nodes (MLNs) and inguinal lymph nodes on CT, MRI or positron emission tomograph (PET)/CT.
  • No contraindications to CT scanning.
  • No evidence of distant metastasis (FIGO stage IVB).
  • 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).

Exclusion criteria

  • With common iliac MLNs.
  • Tumor extended to the lower third of the vagina.
  • Tumor spread to mucosa of the bladder or rectum.
  • Prior surgery (including pelvic or para-aortic lymph nodes resection, except for tumor biopsy), radiotherapy or chemotherapy to primary tumor or nodes.
  • Prior malignancy.
  • History of previous radiotherapy to the abdomen or pelvis.
  • Pregnancy or lactation.
  • Active inflammatory bowel disease, or history of severe stomach or duodenal ulcer.
  • Active infection with fever.
  • Patients with unacceptable risk that intracavitary brachytherapy can not be conducted.
  • 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.

Treatment and study plan

online adaptive radiotherapy

Radiation

PTV with 5-10 margins covers CTV

Primary outcomes

  1. Patient-reported acute toxicity

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

    Patient-reported acute toxicity evaluated with European Organization for Research and Treatment of Cancer Quality of Life C30 (EORTC QLQ-C30) 3.0 questionnaire

  2. Physician-reported acute toxicity

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

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

Secondary outcomes

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

    Time frame: 3-year

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

  2. The irradiated doses of organs at risk

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

    The organs at risk includes bladder, rectum, bone marrow, femur head left, femur head right and bowel that may be irradiated near the target volume

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

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

    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.

  4. Target volume contouring accuracy

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

    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.

  5. Response evaluation evaluated with RECIST 1.1

    Time frame: One month after treatment

    Evaluated with RECIST 1.1

  6. Movement of the uterus during per radiotherapy fractions

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

    The pre- and post-treatment CBCT scans will be obtained during per treatment. The uterus intra-fractional motion were evaluated by comparison of uterus centroid from pre-treatment CBCT and uterus centroid from post-treatment images.

  7. Movement of the cervix during per radiotherapy fractions

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

    The pre- and post-treatment CBCT scans will be obtained during per treatment. The cervix intra-fractional motion were evaluated by comparison of cervix centroid from pre-treatment CBCT and cervix centroid from post-treatment images.

  8. Progression-free survival

    Time frame: 2-year

    Progression-free survival is defined as the time from randomization to disease progression or death from any cause, whichever is first.

  9. Personalized margin for cervical cancer

    Time frame: Six month after treatment

    Pre- and post-treatment images are uploaded to the online adaptive radiotherapy simulator to re-delineate the target volume and determine the personalized margin range.

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Official study title

A Prospective Study to Evaluate Online Adaptive Radiotherapy in Cervical Cancer With Reduced Margin

Important dates

Study start
2023
Primary completion
2023
Study completion
2026
First posted
May 30, 2023
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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