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Extraperitoneal Lymph Node Dissection in Patients With Cervical Cancer

2012년 3월 22일 업데이트: 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)).

연구 개요

상세 설명

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.

연구 유형

관찰

등록 (실제)

65

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

    • Texas
      • Houston, Texas, 미국, 77030
        • UT MD Anderson Cancer Center
      • Houston, Texas, 미국, 77030
        • Lyndon Baines Johnson General Hospital

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 어린이
  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

여성

샘플링 방법

비확률 샘플

연구 인구

Patients diagnosed with stage IB2-IVA cervical cancer.

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트
개입 / 치료
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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Complication Rates
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Pedro Ramirez, MD, M.D. Anderson Cancer Center

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

유용한 링크

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2003년 10월 1일

기본 완료 (실제)

2011년 5월 1일

연구 완료 (실제)

2011년 5월 1일

연구 등록 날짜

최초 제출

2007년 7월 10일

QC 기준을 충족하는 최초 제출

2007년 7월 10일

처음 게시됨 (추정)

2007년 7월 12일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2012년 3월 26일

QC 기준을 충족하는 마지막 업데이트 제출

2012년 3월 22일

마지막으로 확인됨

2012년 3월 1일

추가 정보

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

자궁 경부암에 대한 임상 시험

Extraperitoneal Laparoscopic Lymphadenectomy에 대한 임상 시험

3
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