Reducing Radiation Target Volume for Stage IIb Cervical Cancer

Официальное название

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

Обзор

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.

Вмешательства

• Лучевая терапия 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.

Первичные конечные точки

• 1."Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v4.0" 2."Therapeutic Effect as Assessed by RECIST1.1" [Срок оценки: 4 years]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07249957 · CQGOG0116

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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