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Recruiting

NCT Number: NCT06562166

Online Adaptive Radiotherapy for Cervical Cancer

This study aims to evaluate the clinical efficacy and safety of online adaptive radiotherapy for cervical cancer patients received radical radiotherapy. By comparing with image-guided radiotherapy, the study explores the potential advantages of online adaptive radiotherapy in reducing treatment toxicity and improving local control.

Recruiting

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Key information

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 18-80 years old;
  • Pathologically confirmed diagnosis of cervical cancer and pathological type of cervical squamous carcinoma;
  • 2018 FIGO Stage Ib3, II, IIIB and IIIC1
  • Proposed radical pelvic radiotherapy + concurrent sensitizing chemotherapy (platinum-based (cisplatin 30-40mg/m2 or carboplatin alone), starting concurrently in the first week, ≥5 courses)
  • ECOG score 0-2
  • Life expectancy greater than 6 months
  • Ability to remain lying down for more than 30 minutes
  • Patients were fully voluntary and autonomous and co-operated in signing the study informed consent form
  • Complete blood count and basal metabolic indexes within 14 days before enrolment must meet the following requirements: NEUT ≥ 1.5*109/L, HGB ≥ 60g/L, platelets ≥ 100×109/, blood creatinine <1.5 mg/dL. AST and ALT are within 2 times the upper limit of normal
  • Must complete baseline assessments and investigations required before treatment before enrolment
  • be eligible for regular follow-up

Exclusion criteria

  • Have received radiotherapy or chemotherapy in the past
  • Have undergone radical surgery for cervical cancer
  • Have a previous history of malignant tumor
  • Pregnant or lactating women
  • Presence of other serious co-morbidities such as poorly controlled cardiovascular, urinary, digestive, respiratory, hematological and central nervous system diseases.

Treatment and study plan

online adaptive radiotherapy

Radiation

Patients in ART group received daily online adaptive radiotherapy with a prescription dose of 50.4Gy/28f.

Primary outcomes

  1. Acute non-hematological toxicity

    Time frame: From the start of treatment until 3 months later

    Acute non-hematologic toxicities include gastrointestinal and genitourinary toxicities, which will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

Secondary outcomes

  1. treatment response

    Time frame: 3 months after completion of treatment

    Treatment response will be evaluated according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

Study contacts

Contact information is provided by the study sponsor or research team.

Shuai Sun

CONTACT

[email protected]

15801390180

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Collaborators

  • Affiliated Hospital of Jiangsu University
  • Jingzhou First People's Hospital
  • The First Affiliated Hospital of Nanhua University
  • Tongji Hospital
  • Zhongnan Hospital

Registry information

Official study title

Online Adaptive Radiotherapy (oART) in Radical Radiotherapy for Cervical Cancer - A Multi-center Randomized Controlled Study

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Aug 20, 2024
Registry last updated
Jan 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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