Reducing Radiation Target Volume for Stage IIb Cervical Cancer

Chongqing University Cancer Hospital

Status: Not yet enrolling

Conditions: Stage IIb Cervical Cancer Radical Radiotherapy

Treatments: 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 type: Interventional

Funder types: Other

Identifiers

NCT07249957

CQGOG0116

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 50 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

60 participants in 1 patient group

Radical radiotherapy for IIb cervical cancer to reduce the irradiation area

Experimental group

Treatment:

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.