Stage IIb Cervical Cancer Radical RadiotherapyNCT07249957
Reducing Radiation Target Volume for Stage IIb Cervical Cancer
A study testing The external irradiation area only covers the entire uterus (including the primary lesion in the cervix), bilateral parametrium, and 3 cm below the cervical/vaginal lesions. in people with Stage IIb Cervical Cancer Radical Radiotherapy, run by Chongqing University Cancer Hospital.
Trial summary
This is a domestic single-center prospective clinical trial. The study selected patients with histologically confirmed cervical squamous cell carcinoma, diagnosed as stage IIb according to the FIGO 2018 staging principle (tumor size < 4 cm). Read more about this study
- Who is it for?
- Ages 50 to 75 years, women only
- Conditions the study is for
- Stage IIb Cervical Cancer Radical Radiotherapy
- What is being tested?
- The external irradiation area only covers the entire uterus (including the primary lesion in the cervix), bilateral parametrium, and 3 cm below the cervical/vaginal lesions.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Nov 2025to Oct 2029
- 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 50 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient voluntarily participated in this study and signed the informed consent form;
- Age range: 50 to 75 years old;
- Patients with cervical cancer who had not undergone surgery or chemotherapy and were initially diagnosed with squamous cell carcinoma by pathological histology, and were HPV high-risk positive;
- According to the 2018 International Federation of Gynecology and Obstetrics (FIGO) staging system, it was stage IIb (tumor size < 4 cm);
- ECOG score: 0 to 1, with an expected survival of more than 6 months;
- Pregnant women must undergo a pregnancy test (serum or urine) 7 days before enrollment, and the result must be negative, and they are willing to use appropriate contraceptive methods during the trial;
- According to the investigator's judgment, there are no absolute contraindications to radiotherapy and chemotherapy or surgery, and they can comply with the trial protocol.
Who cannot join
- Active or uncontrolled severe infections;
- Cirrhosis, decompensated liver disease;
- History of immunodeficiency, including HIV positive or having other acquired congenital immune deficiency diseases;
- Chronic renal insufficiency and renal failure;
- Patients with other malignancies that require treatment and/or newly diagnosed within 5 years;
- Myocardial infarction, severe arrhythmia, and ≥ grade 2 congestive heart failure (NYHA classification);
Show all 13Show fewer
- Patients who have undergone pelvic artery embolization;
- Patients who have received radiotherapy for pelvic malignant tumors in the past;
- Patients who have received partial hysterectomy or radical hysterectomy in the past;
- Patients with a history of severe allergic reaction to platinum-based chemotherapy drugs;
- Comorbidities, requiring the use of drugs that cause significant liver and kidney damage during treatment, such as tuberculosis, etc.;
- Patients who cannot understand the experimental content and cannot cooperate, or who refuse to sign the informed consent form;
- Patients with serious accompanying diseases or other special conditions that seriously endanger their safety or affect their ability to complete the study.
About this study
Official title: Reducing Radiation Target Volume in Radical Radiotherapy for Stage IIb Cervical Cancer: A Single-arm Exploratory Study
This is a domestic single-center prospective clinical trial. The study selected patients with histologically confirmed cervical squamous cell carcinoma, diagnosed as stage IIb according to the FIGO 2018 staging principle (tumor size < 4 cm). The patients first received 6 cycles of induction chemotherapy (carboplatin (AUC2) + paclitaxel (80 mg/m2), q1w), followed by concurrent chemoradiotherapy with a platinum-based regimen. The external beam radiation field only covered the entire uterus (including the primary lesion of the cervix), the bilateral parametrium, and the lesion of the cervix/vagina extending 3 cm downward. A total of 60 participants are planned to be included in the study.
- Being tested
- The external irradiation area only covers the entire uterus (including the primary lesion in the cervix), bilateral parametrium, and 3 cm below the cervical/vaginal lesions.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The external irradiation area only covers the entire uterus (including the primary lesion in the cervix), bilateral parametrium, and 3 cm below the cervical/vaginal lesions.Radiation
The external irradiation area only covers the entire uterus (including the primary lesion in the cervix), bilateral parametrium, and 3 cm below the cervical/vaginal lesions.
| Study group | Role | What they receive |
|---|---|---|
| Radical radiotherapy for IIb cervical cancer to reduce the irradiation area | Experimental | Not described Receives: Radiation: The external irradiation area only covers the entire uterus (including the primary lesion in the cervix), bilateral parametrium, and 3 cm below the cervical/vaginal lesions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
1."Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v4.0" 2."Therapeutic Effect as Assessed by RECIST1.1"
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2025
- Study startNov 2025 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionOct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage IIb Cervical Cancer Radical RadiotherapyStudies of the same condition, open and under way.
- 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chongqing University Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dongling Zou, Chongqing University Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07249957
- Sponsor's protocol ID
- CQGOG0116
- Status last verified
- Sep 2025
- First submitted
- 18 Sep 2025
- Last updated
- 25 Nov 2025
- 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 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Radiation Target Volume in Radical Radiotherapy for Stage IIb Cervical Cancer: A Single-arm Exploratory Study
- ClinicalTrials.gov ID
- NCT07249957
- Acronym / sponsor ID
- CQGOG0116
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Chongqing University Cancer HospitalUniversity, hospital or other
- Study start
- Nov 2025 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2029 (estimated)
- First posted
- 25 Nov 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.
This is a domestic single-center prospective clinical trial. The study selected patients with histologically confirmed cervical squamous cell carcinoma, diagnosed as stage IIb according to the FIGO 2018 staging principle (tumor size < 4 cm). The patients first received 6 cycles of induction chemotherapy (carboplatin (AUC2) + paclitaxel (80 mg/m2), q1w), followed by concurrent chemoradiotherapy with a platinum-based regimen. The external beam radiation field only covered the entire uterus (including the primary lesion of the cervix), the bilateral parametrium, and the lesion of the cervix/vagina extending 3 cm downward. A total of 60 participants are planned to be included in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radical radiotherapy for IIb cervical cancer to reduce the irradiation area | Experimental | Radiation: The external irradiation area only covers the entire uterus (including the primary lesion in the cervix), bilateral parametrium, and 3 cm below the cervical/vaginal lesions. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- The patient voluntarily participated in this study and signed the informed consent form;
- Age range: 50 to 75 years old;
- Patients with cervical cancer who had not undergone surgery or chemotherapy and were initially diagnosed with squamous cell carcinoma by pathological histology, and were HPV high-risk positive;
- According to the 2018 International Federation of Gynecology and Obstetrics (FIGO) staging system, it was stage IIb (tumor size < 4 cm);
- ECOG score: 0 to 1, with an expected survival of more than 6 months;
Key exclusion criteria (13 listed)
- Active or uncontrolled severe infections;
- Cirrhosis, decompensated liver disease;
- History of immunodeficiency, including HIV positive or having other acquired congenital immune deficiency diseases;
- Chronic renal insufficiency and renal failure;
- Patients with other malignancies that require treatment and/or newly diagnosed within 5 years;
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 |
|---|---|---|
| The external irradiation area only covers the entire uterus (including the primary lesion in the cervix), bilateral parametrium, and 3 cm below the cervical/vaginal lesions.The external irradiation area only covers the entire uterus (including the primary lesion in the cervix), bilateral parametrium, and 3 cm below the cervical/vaginal lesions. | Radiation | Radical radiotherapy for IIb cervical cancer to reduce the irradiation area |
Primary outcome
1."Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v4.0" 2."Therapeutic Effect as Assessed by RECIST1.1"
Time frame: 4 years
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 25 Nov 2025.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing The external irradiation area only covers the entire uterus (including the primary lesion in the cervix), bilateral parametrium, and 3 cm below the cervical/vaginal lesions. in people with Stage IIb Cervical Cancer Radical Radiotherapy, run by Chongqing University Cancer Hospital.
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 7 inclusion and 13 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 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1."Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v4.0" 2."Therapeutic Effect as Assessed by RECIST1.1" (time frame: 4 years). 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 25 Nov 2025.