Cervical CancerPhase 2NCT06562166
Online Adaptive Radiotherapy for Cervical Cancer
A Phase 2 study testing online adaptive radiotherapy in people with Cervical Cancer, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Cervical Cancer
- 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
- 124 participants
- Where
- 1 siteChina
- Study dates
- 5 Sep 2024to 1 Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking union medical college hospital
Beijing, 100730
Shuai Sun, +86-15540101705, drsunshuai@163.com
About this study
Official title: 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.
- Conditions
- Cervical Cancer
- Being tested
- online adaptive radiotherapy
- Keywords
- cervical cancer, adaptive radiotherapy
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
online adaptive radiotherapyRadiation
Patients in ART group received daily online adaptive radiotherapy with a prescription dose of 50.4Gy/28f.
| Study group | Role | What they receive |
|---|---|---|
| ART | Experimental | Not described Receives: Radiation: online adaptive radiotherapy |
| IGRT | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute non-hematological toxicity
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.
Measured: From the start of treatment until 3 months later
Secondary outcomes (1)
treatment response
Treatment response will be evaluated according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Measured: 3 months after completion of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2024
- Study start5 Sep 2024
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Affiliated Hospital of Jiangsu University, Zhongnan Hospital, Jingzhou First People's Hospital, The First Affiliated Hospital of Nanhua University, Tongji Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06562166
- Sponsor's protocol ID
- ART_cervical cancer
- Status last verified
- Feb 2025
- First submitted
- 16 Aug 2024
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Online Adaptive Radiotherapy (oART) in Radical Radiotherapy for Cervical Cancer - A Multi-center Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06562166
- Acronym / sponsor ID
- ART_cervical cancer
- Conditions
- Cervical Cancer
- Keywords
- cervical cancer, adaptive radiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Collaborators
- Affiliated Hospital of Jiangsu University, Zhongnan Hospital, Jingzhou First People's Hospital, The First Affiliated Hospital of Nanhua University, Tongji Hospital
- Study start
- 5 Sep 2024 (actual)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 20 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ART | Experimental | Radiation: online adaptive radiotherapy |
| IGRT | No intervention | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| online adaptive radiotherapyPatients in ART group received daily online adaptive radiotherapy with a prescription dose of 50.4Gy/28f. | Radiation | ART |
Primary outcome
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.
1 secondary outcome
treatment response
Time frame: 3 months after completion of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing online adaptive radiotherapy in people with Cervical Cancer, 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 11 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 8 Jan 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shuai Sun (15801390180, sunshuai@pumch.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute non-hematological toxicity (time frame: From the start of treatment until 3 months later). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jan 2026.