A Phase III Randomized Study of Pretherapeutic Para-aortic Lymphadenectomy in Women With Locally Advanced Cervical Cancer Dispositioned to Definitive Chemoradiotherapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 5
- 主要终点
- Overall Survival Rate
研究概览
简要总结
The goal of this clinical research study is to learn if a surgical procedure called an extraperitoneal laparoscopic lymphadenectomy followed by chemotherapy and tailored radiation therapy can help to control the disease for a longer time than standard-of-care chemotherapy and whole pelvic radiation therapy.
详细描述
You will have a positron emission tomography/computed tomography (PET/CT) scan to check the status of the disease. For up to 6 hours before the PET/CT scan, you must not eat or drink anything except water. A small tube will be placed in your arm, and you will receive an injection of a very small amount of a mildly radioactive sugar material into your bloodstream. The radioactive nature of this injected material allows the scanner to "see" it in certain places in your body. After the injection, you will need to rest quietly until it is time for the scan. The amount of rest time may vary, but be prepared to wait for between 45 and 90 minutes. During the scan, you will lie flat on your back on a table. The scan itself may last up to 1 hour.
The study doctor will discuss the test results with you. If the test shows that you are not eligible to take part in the study, you will not be enrolled. Other treatment options will be discussed with you.
Study Groups:
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups. You have an equal chance of being assigned to either group.
If you are in Group 1, you will have an extraperitoneal laparoscopic lymphadenectomy followed by chemoradiation therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with clinical stage IB2-IVA cervical squamous cell carcinoma, adenosquamous, or adenocarcinoma.
- •Women with FDG-PET positive or indeterminate pelvic lymph nodes or indeterminate low common iliac nodes and negative paraaortic nodes.
- •Women with planned treatment of primary definitive chemoradiation therapy.
- •Patient information and written informed consent form signed.
- •Age >/= 18 years old
- •ECOG Performance Status (PS) </= 2
- •Life Expectancy >/= 3 months
排除标准
- •Women with stage IA or IB1 cancer.
- •Women with prior radiotherapy to the pelvis or retroperitoneal surgery.
- •Women with neuroendocrine histologies, or histologies other than squamous, adenosquamous or adenocarcinoma.
- •Women with FDG PETpositive high common or paraaortic lymph node metastasis confirmed by biopsy.
- •Women who have undergone simple or radical hysterectomy prior to radiotherapy.
- •Women with planned treatment of radiotherapy only (without chemotherapy).
- •Women with planned treatment of palliative radiotherapy.
- •Women with metastatic disease outside of pelvis.
- •Women who have completed treatment for other malignancies (except non-melanomatous skin cancer) < 5 years from their new diagnosis of cervical cancer.
- •Women who are pregnant, women who are likely to be pregnant or are breastfeeding.
- •Women with any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with patient's safety, provision of informed consent or compliance to study procedures.
- •(French Sites Only) Women not affiliated with Social Security System in France.
- •(French Sites Only) Women deprived of liberty or under guardianship.
结局指标
主要结局
Overall Survival Rate
时间窗: 3 years
To determine if patients with locally advanced cervical cancer have longer overall survivals with pretherapeutic paraaortic surgical staging followed by tailored chemoradiation when compared to patients who undergo standard radiologic staging followed by whole pelvic chemoradiation therapy.
次要结局
未报告次要终点