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NCT07249957

Reducing Radiation Target Volume for Stage IIb Cervical Cancer

Sponsor: Chongqing University Cancer Hospital

View on ClinicalTrials.gov

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.

Official title: Reducing Radiation Target Volume in Radical Radiotherapy for Stage IIb Cervical Cancer: A Single-arm Exploratory Study

Key Details

Gender

FEMALE

Age Range

50 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-11

Completion Date

2029-10

Last Updated

2025-11-25

Healthy Volunteers

Conditions

Stage IIb Cervical Cancer Radical Radiotherapy

Interventions

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.

Inclusion Criteria: 1. The patient voluntarily participated in this study and signed the informed consent form; 2. Age range: 50 to 75 years old; 3. 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; 4. According to the 2018 International Federation of Gynecology and Obstetrics (FIGO) staging system, it was stage IIb (tumor size \< 4 cm); 5. ECOG score: 0 to 1, with an expected survival of more than 6 months; 6. 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; 7. 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. Exclusion Criteria: 1. Active or uncontrolled severe infections; 2. Cirrhosis, decompensated liver disease; 3. History of immunodeficiency, including HIV positive or having other acquired congenital immune deficiency diseases; 4. Chronic renal insufficiency and renal failure; 5. Patients with other malignancies that require treatment and/or newly diagnosed within 5 years; 6. Myocardial infarction, severe arrhythmia, and ≥ grade 2 congestive heart failure (NYHA classification); 7. Patients who have undergone pelvic artery embolization; 8. Patients who have received radiotherapy for pelvic malignant tumors in the past; 9. Patients who have received partial hysterectomy or radical hysterectomy in the past; 10. Patients with a history of severe allergic reaction to platinum-based chemotherapy drugs; 11. Comorbidities, requiring the use of drugs that cause significant liver and kidney damage during treatment, such as tuberculosis, etc.; 12. Patients who cannot understand the experimental content and cannot cooperate, or who refuse to sign the informed consent form; 13. Patients with serious accompanying diseases or other special conditions that seriously endanger their safety or affect their ability to complete the study.