Reducing Radiation Target Volume for Stage IIb Cervical Cancer

NCT07249957 | Not Yet Recruiting DMC

• 1 other identifier: CQGOG0116
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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). 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.

Conditions

Stage IIb Cervical Cancer Radical Radiotherapy

Outcome Measures

Primary Outcomes (1)

• 1."Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v4.0" 2."Therapeutic Effect as Assessed by RECIST1.1"

  4 years

Study Arms (1)

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.

Interventions

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.

Radical radiotherapy for IIb cervical cancer to reduce the irradiation area

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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);
• 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.

Sponsors & Collaborators

• Chongqing University Cancer Hospital: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Dept. of Gynecological Oncology Chongqing University Cancer Hospital

Study Record Dates

• First Submitted: September 18, 2025
• First Posted: November 25, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2029
• Last Updated: November 25, 2025

Record last verified: 2025-09