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A Phase III Randomized Study of Pretherapeutic Para-aortic Lymphadenectomy in Women With Locally Advanced Cervical Cancer Dispositioned to Definitive Chemoradiotherapy


Phase 3
18 Years
N/A
Open (Enrolling)
Female
Cervical Squamous Cell Carcinoma, Adenosquamous Carcinoma, Adenocarcinoma, Locally Advanced Malignant Neoplasm, Cervical Cancer

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Trial Information

A Phase III Randomized Study of Pretherapeutic Para-aortic Lymphadenectomy in Women With Locally Advanced Cervical Cancer Dispositioned to Definitive Chemoradiotherapy


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.


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. An approved Informed Consent and authorization permitting release of personal health
information must be signed by the patient or guardian.

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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Three Year Overall Survival Rate

Outcome Description:

Overall survival (OS) with the product limit estimator of Kaplan and Meier overall survivals with pretherapeutic para-aortic surgical staging followed by tailored chemoradiation when compared to patients who undergo standard radiologic staging followed by whole pelvic chemoradiation therapy after PET scan only.

Outcome Time Frame:

3 years

Safety Issue:

No

Principal Investigator

Michael M. Frumovitz, MD, MPH

Investigator Role:

Study Chair

Investigator Affiliation:

UT MD Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2010-0952

NCT ID:

NCT01365156

Start Date:

August 2011

Completion Date:

Related Keywords:

  • Cervical Squamous Cell Carcinoma
  • Adenosquamous Carcinoma
  • Adenocarcinoma
  • Locally Advanced Malignant Neoplasm
  • Cervical Cancer
  • locally advanced cervical cancer
  • pretherapeutic para-aortic surgical staging
  • radiologic staging
  • pretherapeutic surgical staging
  • para-aortic metastatic disease
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Neoplasms
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Uterine Cervical Neoplasms
  • Carcinoma, Adenosquamous

Name

Location

UT MD Anderson Cancer CenterHouston, Texas  77030