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Extraperitoneal Lymph Node Dissection in Patients With Cervical Cancer

2012年3月22日 更新者:M.D. Anderson Cancer Center

A Pilot Study of Laparoscopic Extraperitoneal Lymph Node Dissection in Patients With Locally Advanced Cervical Cancer

Primary Objectives:

  • To determine the feasibility of performing an extraperitoneal laparoscopic lymphadenectomy in patients with stage IB2-IVA cervical carcinoma who are dispositioned to undergo radiotherapy and concurrent chemotherapy.
  • To document intraoperative and postoperative complications in patients undergoing extraperitoneal laparoscopic lymphadenectomy.
  • To determine the rate of lymph node metastases in the para-aortic region in patients with stage IB2-IVA cervical cancer.
  • To correlate histopathological findings in the para-aortic lymph nodes with preoperative imaging studies (Positron emission tomography (PET) and magnetic resonance imaging (MRI) and computed tomography (CT)).

研究概览

详细说明

Currently, the decision about how much radiation should be given to patients with stage IB2-IVA cervical cancer is based on direct physical examination, chest x-ray, computed tomography (CT) scan, magnetic resonance imaging (MRI) scan, cystoscopy (examination of the bladder), proctoscopy (examination of the rectum), and possibly an intravenous pyelogram (a test that uses dye to outline the bladder, kidneys, and the tubes that carry urine from the kidney to the bladder on an x-ray). Unfortunately, these techniques may not identify cancer that has spread to the lymph nodes. Studies have shown that cancer in the lymph nodes is one of the most important factors in the return of the cancer. Standard radiation therapy treats the lymph nodes in the pelvis area but does not include the lymph nodes in the abdomen (called para aortic lymph nodes) . If cancer is present in the lymph nodes in the abdomen and it was not detected by the standard techniques, the cancer could be undertreated and the risk of the cancer returning would be high.

Using a surgical procedure called extraperitoneal laparoscopic lymphadenectomy, surgeons can remove and examine the lymph nodes in the abdomen. This may help to find cancer in the lymph nodes that cannot be detected using standard techniques. If these lymph nodes contain cancer, the area of the body treated with radiation can be "extended" to treat new areas. This means that radiation will be used to treat both the para-aortic lymph nodes (lymph nodes in the abdomen) in addition to the standard pelvic radiation.

Before beginning your radiation therapy, you will be taken to the operating room for the laparoscopy procedure. The laparoscopy procedure involves placing a telescope-like instrument through a small, usually ½ inch, incision (cut) in the abdomen. Three other small incisions are made to place additional instruments that may be needed to complete the surgery. Before the laparoscope is inserted, carbon dioxide gas (CO2) is introduced into the side of the abdomen. This gas helps to separate the organs inside the abdominal cavity, making it easier for the surgeon to see. The laparoscope is then inserted through the small incision. The laparoscope has a small camera on the end of the instrument. This is attached to a high-resolution TV monitor. Using the TV monitor, the surgeon can see inside your body without making a large incision. While watching the TV monitor, the surgeon uses the laparoscope to find the para aortic lymph nodes and removes them. Once the procedure is finished, the carbon dioxide gas is removed and you are taken to the recovery room.

The lymph nodes that were removed will be sent to the lab and evaluated for the presence of any cancer cells. If cancer is found, your radiation therapy will be adjusted to also treat the lymph nodes. If no signs of cancer is found, you will receive the standard radiation therapy.

If, during the laparoscopy procedure, the surgeon finds an obvious sign of cancer (such as enlarged lymph nodes) then an exploratory laparotomy will be performed. This procedure involves making a long incision in the abdomen so that the surgeon can remove any additional lymph nodes that may contain cancer.

All participants will undergo a Positron Emission Tomography scan, also called a PET scan, before their scheduled surgery. This test studies the function of organs such as the heart, brain, and bone. The test is different from other imaging tests such as x-rays, CT scans, or MRI's because PET images show how tissues function. The other imaging methods show what the tissues look like. The PET scanner is similar to a CT or an MRI scanner. The bed on the scanner moves during the exam so that each area of the body can be imaged. The PET scanner makes no noise.

Before the PET scan, a blood test (about 1 teaspoon) will be done to check your blood sugar level. The day before the scan, you will be asked to follow a special diet. This is to control the amount of sugar in your bloodstream. One the day of the scan a small tube will be placed in your vein to administer a very small amount of radioactive material. This material allows the PET scanner to "see" where the sugar is metabolized in your body. The amount of time the scan takes depends on how tall you are and why you are having the test. After the scan, patients rest for about 45 to 90 minutes before being discharged. Family members are not allowed to come in with the patient during the test. Overall, you should allow about 3 hours for this scan. If you had this test prior to entering the study, you do not have to have this test repeated as long as it was done within 4 weeks of the laparoscopy.

This is an investigational study. The PET/CT scan will be performed only at M. D. Anderson and the laparoscopy procedure will be performed at both M. D. Anderson and Lyndon Baines Johnson General Hospital (LBJGH). The chemotherapy and/or radiation treatments may be done at either MD Anderson or in your hometown. Up to 70 patients will be enrolled in this multicenter study. Up to 55 will be enrolled at M. D. Anderson.

研究类型

观察性的

注册 (实际的)

65

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Texas
      • Houston、Texas、美国、77030
        • UT MD Anderson Cancer Center
      • Houston、Texas、美国、77030
        • Lyndon Baines Johnson General Hospital

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人
  • 年长者

接受健康志愿者

有资格学习的性别

女性

取样方法

非概率样本

研究人群

Patients diagnosed with stage IB2-IVA cervical cancer.

描述

Inclusion Criteria:

  • Patients with stage IB2-IVA cervical cancer who are candidates for treatment with radiotherapy and concurrent chemotherapy.
  • Patients with biopsy-proven cervical carcinoma, any histology.
  • Patients must have no evidence of para aortic lymphadenopathy (< 2cm in diameter) on the preoperative computed tomography (CT) or magnetic resonance imaging (MRI) scan of the abdomen and pelvis.
  • Patients must sign an IRB approved informed consent.
  • Patients with adequate bone marrow, renal and hepatic function: White Blood Count (WBC) >/= 3,000 cells/mcl, Platelets >/= 100,000/mcl, Creatinine </= 2.0 mg%, Bilirubin </= 1.5 x the upper limit of normal and Serum glutamic pyruvic transaminase (SGPT) </= 3 x the upper limit of normal.
  • Zubrod Performance Status of 0, 1, or 2.
  • Patients must be suitable candidates for surgery.
  • Patients who had a PET/CT scan prior to study entry are eligible if a) the study was done within 4 weeks of surgery, and b) they have no evidence of para aortic lymphadenopathy (< 2cm in diameter) on either a preoperative CT or MRI scan of the abdomen and pelvis.

Exclusion Criteria:

  • Patients who have had prior retroperitoneal surgery.
  • Patients who have received prior pelvic or abdominal radiotherapy.
  • Patients known to have upper abdominal intraperitoneal disease or evidence of ovarian metastases.
  • Patients who are pregnant.
  • Patients with evidence of distant metastases on chest x-ray, CT or MRI scan or by physical examination.
  • Patients with contraindications to laparoscopy.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
干预/治疗
Laparoscopy Procedure
Laparoscopy procedure in abdomen to remove para aortic lymph nodes of patients diagnosed with cervical cancer.
Laparoscope used to find and remove para aortic lymph nodes in abdomen.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Complication Rates
大体时间:6 Years
Complication rates determined as number of participants with inherent complications to procedure calculated separately from overall complications divided by to total number of participants.
6 Years

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Pedro Ramirez, MD、M.D. Anderson Cancer Center

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2003年10月1日

初级完成 (实际的)

2011年5月1日

研究完成 (实际的)

2011年5月1日

研究注册日期

首次提交

2007年7月10日

首先提交符合 QC 标准的

2007年7月10日

首次发布 (估计)

2007年7月12日

研究记录更新

最后更新发布 (估计)

2012年3月26日

上次提交的符合 QC 标准的更新

2012年3月22日

最后验证

2012年3月1日

更多信息

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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