Locally Advanced Cervical CancerNCT06882473
A Clinical Study of Pelvic Concurrent Chemoradiotherapy Combined with CT-guided Intracavitary Brachytherapy with Adaptive Simultaneous Dose Escalation for Locally Advanced Cervical Cancer
A study testing Brachytherapy and CT-guided online adaptive external beam pelvic radiotherapy are delivered on the same day in people with Locally Advanced Cervical Cancer, run by Peking University Third Hospital at 1 site in China.
Trial summary
The standard treatment for locally advanced cervical cancer is cisplatin-based concurrent chemoradiotherapy with external beam radiotherapy (EBRT) and Brachytherapy (BT). overall treatment time (OTT) has been found to be an important predictor of treatment response. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Locally Advanced Cervical Cancer
- What is being tested?
- Brachytherapy and CT-guided online adaptive external beam pelvic radiotherapy are delivered on the same day
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 15 Mar 2025to 15 Mar 2027
- Phase
- Interventional
- 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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sign the informed consent;
- Age :18 to 75 years old;
- Histologically or cytologically confirmed cervical cancer;
- According to the International Federation of Gynecology and Obstetrics (FIGO 2018) stage IB3, IIA2, IIB, III, IV (local advanced), and had not received treatment before enrollment;
- Measurable lesions according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1;
- ECOG physical performance score 0-2;
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- Expected survival time >= 3 months;
- LVEF >= 55%;
- Bone marrow function: neutrophil >= 1.5×109/L, platelet ≥ 100×109/L, white blood cell 4.0-10.0×109/L, hemoglobin >= 90 g/L;
- Liver and kidney function: serum creatinine <= 1.5 times upper limit of normal; AST and ALT≤2.5 times upper limit of normal (ULN) or <= 5 times ULN in the presence of liver metastasis; Total bilirubin <=1.5 times upper limit of normal, or <= 2.5 times upper limit of normal if the patient has Gilbert's syndrome;
- Subjects of childbearing age must agree to use effective contraception during the trial, and women of childbearing age must have a negative serum or urine pregnancy test;
- Non-lactating patients;
Who cannot join
- Patients with prior abdominal or pelvic radiotherapy;
- being mentally ill and unable to cooperate with treatment;
- Serious uncontrolled medical diseases, such as serious internal medical diseases, including severe heart disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension, uncontrolled infection, active peptic ulcer, etc.;
- Unable to tolerate cisplatin chemotherapy;
- receiving other experimental drugs or participating in clinical trials for other anticancer treatment purposes within 30 days before the first radiotherapy;
- Severe infection within 4 weeks before study treatment, including but not limited to infectious complications requiring hospitalization, bacteremia, or severe pneumonia;
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- Human immunodeficiency virus (HIV) -positive persons;
- HBsAg positive and HBV-DNA titer >= 1×10^3 IU/mL; Participants were eligible for inclusion if they were HBsAg positive and had a peripheral blood HBV-DNA level of < 1×10^3 IU/mL, and if the investigator considered the participant to be in a stable phase of chronic hepatitis B without increasing the risk to the participant.
- Hepatitis C virus (HCV) antibody positive or human immunodeficiency virus (HIV) antibody positive and HCV RNA test positive;
- Patients judged by the investigator to be ineligible for the study.
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
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
Zhichen Lin, 86+13121135252, 1910301321@pku.edu.cn
About this study
The standard treatment for locally advanced cervical cancer is cisplatin-based concurrent chemoradiotherapy with external beam radiotherapy (EBRT) and Brachytherapy (BT). overall treatment time (OTT) has been found to be an important predictor of treatment response. Some studies have shown that the acceleration of tumor cell regeneration during the extension of radiotherapy leads to poor local control. Prolonging the overall treatment time of cervical cancer radiotherapy for more than 8 weeks leads to an increase in pelvic local control failure. Therefore, shortening OTT has great potential benefits from both clinical efficacy and social benefits. Shortening OTT in radical cervical cancer radiotherapy includes hypofractionated EBRT and shortening the interval between BT and EBRT. However, further shortening OTT may lead to an increase in acute and late toxicity. Adaptive radiotherapy (ART) strategies systematically monitor variations in target and neighbouring structures to inform treatment-plan modification during radiotherapy. The application of image-guided adaptive brachytherapy (IGABT) has clearly demonstrated the advantages of this approach in the treatment of cervical cancer. Previous studies have shown that the implementation of IGABT can achieve personalized treatment, dose increase, improve clinical efficacy, reduce normal tissue toxicity and side effects, and strengthen international standardized quality control. In this study, online adaptive pelvic EBRT combined with IGABT based on uRT-linac was performed under online CT guidance.
The aim of this study is to evaluate the safety and efficacy of pelvic concurrent chemoradiotherapy combined with CT-guided intracavitary brachytherapy with adaptive simultaneous dose escalation in locally advanced cervical cancer.
- Conditions
- Locally Advanced Cervical Cancer
- Being tested
- Brachytherapy and CT-guided online adaptive external beam pelvic radiotherapy are delivered on the same day
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brachytherapy and CT-guided online adaptive external beam pelvic radiotherapy are delivered on the same dayOther
Brachytherapy and CT-guided online adaptive external beam pelvic radiotherapy are delivered on the same day.
| Study group | Role | What they receive |
|---|---|---|
| treatment group | Experimental | External beam radiation therapy: The patients are irradiated with 6MV X-rays at 1.8Gy per fraction, 5 fractions per week, with a total dose of 45-50.4Gy in 25-28 fractions for 5-6 weeks.
Brachytherapy: CT-guided 192Ir high dose rate brachytherapy is used, twice a week, on the same day as external beam radiation therapy, 6Gy per fraction, a total dose of 30Gy. The total radiotherapy dose shouldn't be less than 85Gy EQD2. The overall treatment time ≤ 45 days.
Chemotherapy: Cisplatin 40 mg/m2, d1, i.v. weekly. Six cycles of concurrent chemotherapy should be completed. Treatment continued until disease progression, unacceptable toxic effects happened, or a decision by the investigator and/or patient to discontinue treatment. Receives: Other: Brachytherapy and CT-guided online adaptive external beam pelvic radiotherapy are delivered on the same day |
What is being measured
The primary outcome is the main question the study is designed to answer.
the nature of adverse events
the nature of adverse events is assessd by RTOG/EORTC radiation toxicity grading
Measured: The time frame extends from the initiation of radiotherapy to 24 months after the completion of radiotherapy
the frequency of adverse events
Measured: The time frame extends from the initiation of radiotherapy to 24 months after the completion of radiotherapy
Secondary outcomes (3)
objective response rate
Measured: The time frame extends from the initiation of radiotherapy to 12 months after the completion of radiotherapy
tumor control rate
Measured: The time frame extends from the initiation of radiotherapy to 24 months after the completion of radiotherapy
local progression-free survival time
Measured: The time frame extends from the initiation of radiotherapy until the first recorded local recurrence, with an initial assessment period of 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2025
- Study start15 Mar 2025 (estimated)
- Primary completion15 Mar 2027 (estimated)
- Study completion15 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Cervical CancerStudies of the same condition, open and under way.
- More trials run by Peking University Third 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ping Jiang, Study director, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06882473
- Sponsor's protocol ID
- 797-02
- Status last verified
- Mar 2025
- First submitted
- 7 Feb 2025
- Last updated
- 18 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study of Pelvic Concurrent Chemoradiotherapy Combined with CT-guided Intracavitary Brachytherapy with Adaptive Simultaneous Dose Escalation for Locally Advanced Cervical Cancer
- ClinicalTrials.gov ID
- NCT06882473
- Acronym / sponsor ID
- 797-02
- Conditions
- Locally Advanced Cervical Cancer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 15 Mar 2025 (estimated)
- Primary completion
- 15 Mar 2027 (estimated)
- Study completion
- 15 Mar 2027 (estimated)
- First posted
- 18 Mar 2025 (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.
The standard treatment for locally advanced cervical cancer is cisplatin-based concurrent chemoradiotherapy with external beam radiotherapy (EBRT) and Brachytherapy (BT). overall treatment time (OTT) has been found to be an important predictor of treatment response. Some studies have shown that the acceleration of tumor cell regeneration during the extension of radiotherapy leads to poor local control. Prolonging the overall treatment time of cervical cancer radiotherapy for more than 8 weeks leads to an increase in pelvic local control failure. Therefore, shortening OTT has great potential benefits from both clinical efficacy and social benefits. Shortening OTT in radical cervical cancer radiotherapy includes hypofractionated EBRT and shortening the interval between BT and EBRT. However, further shortening OTT may lead to an increase in acute and late toxicity. Adaptive radiotherapy (ART) strategies systematically monitor variations in target and neighbouring structures to inform treatment-plan modification during radiotherapy. The application of image-guided adaptive brachytherapy (IGABT) has clearly demonstrated the advantages of this approach in the treatment of cervical cancer. Previous studies have shown that the implementation of IGABT can achieve personalized treatment, dose increase, improve clinical efficacy, reduce normal tissue toxicity and side effects, and strengthen international standardized quality control. In this study, online adaptive pelvic EBRT combined with IGABT based on uRT-linac was performed under online CT guidance.
The aim of this study is to evaluate the safety and efficacy of pelvic concurrent chemoradiotherapy combined with CT-guided intracavitary brachytherapy with adaptive simultaneous dose escalation in locally advanced cervical cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment group | Experimental | Other: Brachytherapy and CT-guided online adaptive external beam pelvic radiotherapy are delivered on the same dayExternal beam radiation therapy: The patients are irradiated with 6MV X-rays at 1.8Gy per fraction, 5 fractions per week, with a total dose of 45-50.4Gy in 25-28 fractions for 5-6 weeks. Brachytherapy: CT-guided 192Ir high dose rate brachytherapy is used, twice a week, on the same day as external beam radiation therapy, 6Gy per fraction, a total dose of 30Gy. The total radiotherapy dose shouldn't be less than 85Gy EQD2. The overall treatment time ≤ 45 days. Chemotherapy: Cisplatin 40 mg/m2, d1, i.v. weekly. Six cycles of concurrent chemotherapy should be completed. Treatment continued until disease progression, unacceptable toxic effects happened, or a decision by the investigator and/or patient to discontinue treatment. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Sign the informed consent;
- Age :18 to 75 years old;
- Histologically or cytologically confirmed cervical cancer;
- According to the International Federation of Gynecology and Obstetrics (FIGO 2018) stage IB3, IIA2, IIB, III, IV (local advanced), and had not received treatment before enrollment;
- Measurable lesions according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1;
Key exclusion criteria (10 listed)
- Patients with prior abdominal or pelvic radiotherapy;
- being mentally ill and unable to cooperate with treatment;
- Serious uncontrolled medical diseases, such as serious internal medical diseases, including severe heart disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension, uncontrolled infection, active peptic ulcer, etc.;
- Unable to tolerate cisplatin chemotherapy;
- receiving other experimental drugs or participating in clinical trials for other anticancer treatment purposes within 30 days before the first radiotherapy;
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 |
|---|---|---|
| Brachytherapy and CT-guided online adaptive external beam pelvic radiotherapy are delivered on the same dayBrachytherapy and CT-guided online adaptive external beam pelvic radiotherapy are delivered on the same day. | Other | treatment group |
Primary outcome
the nature of adverse events
Time frame: The time frame extends from the initiation of radiotherapy to 24 months after the completion of radiotherapy
the nature of adverse events is assessd by RTOG/EORTC radiation toxicity grading
the frequency of adverse events
Time frame: The time frame extends from the initiation of radiotherapy to 24 months after the completion of radiotherapy
3 secondary outcomes
objective response rate
Time frame: The time frame extends from the initiation of radiotherapy to 12 months after the completion of radiotherapy
tumor control rate
Time frame: The time frame extends from the initiation of radiotherapy to 24 months after the completion of radiotherapy
local progression-free survival time
Time frame: The time frame extends from the initiation of radiotherapy until the first recorded local recurrence, with an initial assessment period of 24 months.
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 18 Mar 2025.
- Individual participant dataSharing planned: No
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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.
Ping Jiang study director
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brachytherapy and CT-guided online adaptive external beam pelvic radiotherapy are delivered on the same day in people with Locally Advanced Cervical Cancer, run by Peking University Third 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 12 inclusion and 10 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: opening soon, as of the sponsor's last update on 18 Mar 2025. 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.
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 Junjie Wang professor (0086-17355240686, junjiewang@pku.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the nature of adverse events (time frame: The time frame extends from the initiation of radiotherapy to 24 months after the completion of radiotherapy). The study lists 2 primary outcomes in all. 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 18 Mar 2025.