Clinical trial NCT01365156: Extraperitoneal Para-aortic Lymph Node Dissection (EPLND) for Cervix
Official title: A Phase III Randomized Study of Pretherapeutic Para-aortic Lymphadenectomy in Women With Locally Advanced Cervical Cancer Dispositioned to Definitive Chemoradiotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cervical Squamous Cell Carcinoma
Adenosquamous Carcinoma
Adenocarcinoma
Locally Advanced Malignant Neoplasm
Cervical Cancer
Keywords: locally advanced cervical cancer
pretherapeutic para-aortic surgical staging
radiologic staging
pretherapeutic surgical staging
para-aortic metastatic disease
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2011-06-03
Enrollment: 28
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

If you are in Group 2, you will receive standard-of-care chemoradiation therapy only.

Study Procedure and Visits:

If you are in Group 1, you will have an extraperitoneal laparoscopic lymphadenectomy, a procedure where surgeons remove and examine the lymph nodes in the abdomen. The study doctor will explain the risks for this procedure to you and you will sign a separate surgical consent form. This procedure will be performed 7-10 days before chemoradiation treatment begins.

During the laparoscopy procedure, a telescope-like instrument with a small camera on the end (a laparoscope) will be placed through a small cut in the abdomen. Three (3) other small cuts will be made to place instruments that may be needed to complete the surgery. Before the laparoscope is inserted, carbon dioxide gas will be pumped into your abdomen making it easier for the surgeon to see. The laparoscope will then be placed through the small cut. Using a TV monitor, the surgeon will use the camera to find the lymph nodes in the abdomen and then remove them. After the procedure is finished, the carbon dioxide gas will be removed and you will be taken to the recovery room.

If these lymph nodes contain cancer, the area of the body treated with radiation can be "extended" to treat new areas. Future treatment options will be based on what is found. This means that radiation will be used to treat both the lymph nodes in the abdomen and the standard area of radiation in the pelvis.

Participants in both groups will then have radiation for 5 days in a row for 5 to 5½ weeks. If the study doctor thinks it is needed and you agree, you will have extra radiation treatments.

Participants in both groups will receive cisplatin chemotherapy by vein over about 2 hours, 1 time every week for about 6 weeks. In most cases, treatment is given on Mondays (Days 1, 8, 15, 22, 29, and 36).

After 5 to 5½ weeks of chemotherapy and radiation treatment, participants in both groups will receive implants in the pelvis for about 48 hours. You will remain in the hospital at this time. The study doctor will explain the risks for this procedure to you and you will sign a separate surgical consent form.

Length of Study:

You may be on study for up to 5 years. Your participation on the study will be over after you have completed radiation treatment and the follow-up visits described below. You may be taken off study if intolerable side effects occur or if you are unable to follow study directions.

Long-Term Follow-Up:

The following tests and procedures will be performed:

* You will have a PET scan to check the status of the disease 3 months after you complete radiation treatment.
* You have a CT scan to check the status of the disease every 6 months for the next 3 years after that.

You will visit the clinic for a physical exam:

* Every 3 months for the first 2 years
* Every 6 months for the next 3 years, and
* One (1) time each year after that, up to 5 years

This is an investigational study. The extraperitoneal laparoscopic lymphadenectomy is considered investigational. Chemoradiation treatment is FDA approved for the treatment of cervical cancer.

Up to 600 patients will take part in this multicenter study. Up to 40 will be enrolled at MD Anderson. Up to 15 will be enrolled at the Harris Health System.

Eligibility criteria: Inclusion Criteria:

1. Women with clinical stage IB2-IVA cervical squamous cell carcinoma, adenosquamous, or adenocarcinoma.
2. Women with FDG-PET positive or indeterminate pelvic lymph nodes or indeterminate low common iliac nodes and negative paraaortic nodes.
3. Women with planned treatment of primary definitive chemoradiation therapy.
4. Patient information and written informed consent form signed.
5. Age \>/= 18 years old
6. ECOG Performance Status (PS) \</= 2
7. Life Expectancy \>/= 3 months

Exclusion Criteria:

1. Women with stage IA or IB1 cancer.
2. Women with prior radiotherapy to the pelvis or retroperitoneal surgery.
3. Women with neuroendocrine histologies, or histologies other than squamous, adenosquamous or adenocarcinoma.
4. Women with FDG PETpositive high common or paraaortic lymph node metastasis confirmed by biopsy.
5. Women who have undergone simple or radical hysterectomy prior to radiotherapy.
6. Women with planned treatment of radiotherapy only (without chemotherapy).
7. Women with planned treatment of palliative radiotherapy.
8. Women with metastatic disease outside of pelvis.
9. Women who have completed treatment for other malignancies (except non-melanomatous skin cancer) \< 5 years from their new diagnosis of cervical cancer.
10. Women who are pregnant, women who are likely to be pregnant or are breastfeeding.
11. 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.
12. (French Sites Only) Women not affiliated with Social Security System in France.
13. (French Sites Only) Women deprived of liberty or under guardianship.

Primary outcomes:
measure: Overall Survival Rate
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Lyndon B. Johnson General Hospital
state: Texas
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
city: Brussels
country: Belgium
facility: Vall d'Hebron Hospital
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Michael M. Frumovitz, MD, MPH
role: STUDY_CHAIR
References: