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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2011-02400 | Registry Identifier | NCI CTRP |
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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.
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 visit the clinic for a physical exam:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EPLND + Chemoradiation | Experimental | Group 1: Extraperitoneal laparoscopic lymphadenectomy followed by chemoradiation therapy |
|
| Chemoradiation | Active Comparator | Group 2: standard-of-care chemoradiation therapy only |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Extraperitoneal laparoscopic lymphadenectomy (EPLND) | Procedure | Laparoscopic surgical procedure to remove and examine lymph nodes in abdomen, 7-10 days before chemoradiation treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival Rate | 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. | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael M. Frumovitz, MD, MPH | M.D. Anderson Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lyndon B. Johnson General Hospital | Houston | Texas | 77026 | United States | ||
| University of Texas MD Anderson Cancer Center |
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| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Website | View source |
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The study was activated on 08/03/2011 and closed to new patient entry on 03/18/2016. All recruitments were done in a medical clinic setting.
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| ID | Title | Description |
|---|---|---|
| FG000 | Surgery Group | Laparoscopic extraperitoneal paraaortic lymphadenectomy followed by tailored chemoradiation |
| FG001 | Chemoradiation Group | Standard of care whole pelvic chemoradiation therapy |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 24, 2012 |
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|
| Chemoradiation | Radiation | Radiation for 5 days in a row for 5 to 5½ weeks plus Cisplatin Chemotherapy cisplatin chemotherapy by vein over about 2 hours, 1 time every week for about 6 weeks. |
|
| Houston |
| Texas |
| 77030 |
| United States |
| Vall d'Hebron Hospital | Brussels | Belgium |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Surgery Group | Laparoscopic extraperitoneal paraaortic lymphadenectomy followed by tailored chemoradiation |
| BG001 | Chemoradiation Group | Standard of care whole pelvic chemoradiation therapy |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Overall Survival Rate | 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. | Due to lack of funding and low accrual we were unable to determine the Overall Survival Rate. | Posted | 3 years |
|
|
AEs will be collected from the time the patient signs the informed consent form up to 6 months post treatment, up to 8 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Surgery Group | Laparoscopic extraperitoneal paraaortic lymphadenectomy followed by tailored chemoradiation | 0 | 14 | 0 | 14 | 5 | 14 |
| EG001 | Chemoradiation Group | Standard of care whole pelvic chemoradiation therapy | 0 | 14 | 0 | 14 | 3 | 14 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Rectal Hemorrhage | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Vaginal discharge | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dyspareunia | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hot flashes | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Urinary frequency | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Frumovitz,Professor, Gyn Onc & Reproductive Med | UT MD Anderson Cancer Center | (713) 792-9599 | mfrumovitz@mdanderson.org |
| Jan 5, 2021 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D018196 | Carcinoma, Adenosquamous |
| D000230 | Adenocarcinoma |
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D018193 | Neoplasms, Complex and Mixed |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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| ID | Term |
|---|---|
| D059248 | Chemoradiotherapy |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
| D011878 | Radiotherapy |
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| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| United States |
|