Cervical CancerNCT00500435
Extraperitoneal Lymph Node Dissection in Patients With Cervical Cancer
An observational study of Cervical Cancer, run by M.D. Anderson Cancer Center at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- Extraperitoneal Laparoscopic Lymphadenectomy
- Type of treatment
- Surgery or procedure
- How many people
- 65 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2003to May 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients diagnosed with stage IB2-IVA cervical cancer.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Lyndon Baines Johnson General Hospital
Houston, Texas, 77030
UT MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: 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)).
Read the detailed description
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.
- Conditions
- Cervical Cancer
- Being tested
- Extraperitoneal Laparoscopic Lymphadenectomy
- Keywords
- Cervical Cancer, Laparoscopy, Lymph Node Dissection, Extraperitoneal Laparoscopic Lymphadenectomy
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extraperitoneal Laparoscopic LymphadenectomyProcedure or surgery
Laparoscope used to find and remove para aortic lymph nodes in abdomen.
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopy Procedure | Laparoscopy procedure in abdomen to remove para aortic lymph nodes of patients diagnosed with cervical cancer. Receives: Procedure: Extraperitoneal Laparoscopic Lymphadenectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complication Rates
Complication rates determined as number of participants with inherent complications to procedure calculated separately from overall complications divided by to total number of participants.
Measured: 6 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2007 (estimated)
- Study startOct 2003
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pedro Ramirez, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00500435
- Sponsor's protocol ID
- ID03-0098
- Status last verified
- Mar 2012
- First submitted
- 10 Jul 2007
- Last updated
- 26 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Laparoscopic Extraperitoneal Lymph Node Dissection in Patients With Locally Advanced Cervical Cancer
- ClinicalTrials.gov ID
- NCT00500435
- Acronym / sponsor ID
- ID03-0098
- Conditions
- Cervical Cancer
- Keywords
- Cervical Cancer, Laparoscopy, Lymph Node Dissection, Extraperitoneal Laparoscopic Lymphadenectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Oct 2003
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 12 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)).
Detailed description
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Laparoscopy Procedure | – | Procedure: Extraperitoneal Laparoscopic LymphadenectomyLaparoscopy procedure in abdomen to remove para aortic lymph nodes of patients diagnosed with cervical cancer. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients diagnosed with stage IB2-IVA cervical cancer.
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extraperitoneal Laparoscopic LymphadenectomyLaparoscope used to find and remove para aortic lymph nodes in abdomen. | Procedure or surgery | Laparoscopy Procedure |
Primary outcome
Complication Rates
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2012.
- MD Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pedro Ramirez, MD principal investigator
M.D. Anderson Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Cancer, run by M.D. Anderson Cancer Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complication Rates (time frame: 6 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2012.