Online Adaptive Radiotherapy for Cervical Cancer

January 7, 2026 updated by: Peking Union Medical College Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

124

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China, 100730
        • Recruiting
        • Peking Union Medical College Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. 18-80 years old;
  2. Pathologically confirmed diagnosis of cervical cancer and pathological type of cervical squamous carcinoma;
  3. 2018 FIGO Stage Ib3, II, IIIB and IIIC1
  4. Proposed radical pelvic radiotherapy + concurrent sensitizing chemotherapy (platinum-based (cisplatin 30-40mg/m2 or carboplatin alone), starting concurrently in the first week, ≥5 courses)
  5. ECOG score 0-2
  6. Life expectancy greater than 6 months
  7. Ability to remain lying down for more than 30 minutes
  8. Patients were fully voluntary and autonomous and co-operated in signing the study informed consent form
  9. 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
  10. Must complete baseline assessments and investigations required before treatment before enrolment
  11. be eligible for regular follow-up

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ART
Radiation: online adaptive radiotherapy
Patients in ART group received daily online adaptive radiotherapy with a prescription dose of 50.4Gy/28f.
No Intervention: IGRT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From the start of treatment until 3 months later

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months after completion of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 5, 2024

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

August 16, 2024

First Submitted That Met QC Criteria

August 16, 2024

First Posted (Actual)

August 20, 2024

Study Record Updates

Last Update Posted (Actual)

January 8, 2026

Last Update Submitted That Met QC Criteria

January 7, 2026

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ART_cervical cancer

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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