Reducing Radiation Target Volume in Radical Radiotherapy for Stage IIb Cervical Cancer: A Single-arm Exploratory Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 主要终点
- 1."Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v4.0" 2."Therapeutic Effect as Assessed by RECIST1.1"
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Radical radiotherapy for IIb cervical cancer to reduce the irradiation area
干预措施: 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)
结局指标
主要结局
1."Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v4.0" 2."Therapeutic Effect as Assessed by RECIST1.1"
时间窗: 4 years
次要结局
未报告次要终点
研究者
Dongling Zou
Director of Dept. of Gynecological Oncology Chongqing University Cancer Hospital
Chongqing University Cancer Hospital