Cervical Squamous Cell CarcinomaPhase 3NCT01365156
Extraperitoneal Para-aortic Lymph Node Dissection (EPLND) for Cervix
A Phase 3 study testing Extraperitoneal laparoscopic lymphadenectomy (EPLND) and Chemoradiation in people with Cervical Squamous Cell Carcinoma and Adenosquamous Carcinoma, run by M.D. Anderson Cancer Center at 3 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Squamous Cell Carcinoma, Adenosquamous Carcinoma, Adenocarcinoma
- What is being tested?
- Extraperitoneal laparoscopic lymphadenectomy (EPLND) and Chemoradiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Aug 2011to 24 Jan 2020
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women with clinical stage IB2-IVA cervical squamous cell carcinoma, adenosquamous, or adenocarcinoma.
- Women with FDG-PET positive or indeterminate pelvic lymph nodes or indeterminate low common iliac nodes and negative paraaortic nodes.
- Women with planned treatment of primary definitive chemoradiation therapy.
- Patient information and written informed consent form signed.
- Age >/= 18 years old
- ECOG Performance Status (PS) </= 2
- Life Expectancy >/= 3 months
Who cannot join
- Women with stage IA or IB1 cancer.
- Women with prior radiotherapy to the pelvis or retroperitoneal surgery.
- Women with neuroendocrine histologies, or histologies other than squamous, adenosquamous or adenocarcinoma.
- Women with FDG PETpositive high common or paraaortic lymph node metastasis confirmed by biopsy.
- Women who have undergone simple or radical hysterectomy prior to radiotherapy.
- Women with planned treatment of radiotherapy only (without chemotherapy).
Show all 13Show fewer
- Women with planned treatment of palliative radiotherapy.
- Women with metastatic disease outside of pelvis.
- Women who have completed treatment for other malignancies (except non-melanomatous skin cancer) < 5 years from their new diagnosis of cervical cancer.
- Women who are pregnant, women who are likely to be pregnant or are breastfeeding.
- 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.
- (French Sites Only) Women not affiliated with Social Security System in France.
- (French Sites Only) Women deprived of liberty or under guardianship.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
Lyndon B. Johnson General Hospital
Houston, Texas, 77026
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: A Phase III Randomized Study of Pretherapeutic Para-aortic Lymphadenectomy in Women With Locally Advanced Cervical Cancer Dispositioned to Definitive Chemoradiotherapy
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.
Read the 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.
- Conditions
- Cervical Squamous Cell Carcinoma, Adenosquamous Carcinoma, Adenocarcinoma, Locally Advanced Malignant Neoplasm, Cervical Cancer
- Being tested
- Extraperitoneal laparoscopic lymphadenectomy (EPLND), Chemoradiation
- Keywords
- locally advanced cervical cancer, pretherapeutic para-aortic surgical staging, radiologic staging, pretherapeutic surgical staging, para-aortic metastatic disease
- Medical subject headings
- Carcinoma, Adenosquamous, Adenocarcinoma, Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extraperitoneal laparoscopic lymphadenectomy (EPLND)Procedure or surgery
Also called Laparoscopic Extraperitoneal lymphadenectomy, Extraperitoneal Para-aortic Lymph Node Dissection, EPLND
Laparoscopic surgical procedure to remove and examine lymph nodes in abdomen, 7-10 days before chemoradiation treatment
ChemoradiationRadiation
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.
| Study group | Role | What they receive |
|---|---|---|
| EPLND + Chemoradiation | Experimental | Group 1: Extraperitoneal laparoscopic lymphadenectomy followed by chemoradiation therapy Receives: Procedure: Extraperitoneal laparoscopic lymphadenectomy (EPLND); Radiation: Chemoradiation |
| Chemoradiation | Active comparator | Group 2: standard-of-care chemoradiation therapy only Receives: Radiation: Chemoradiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2011 (estimated)
- Study startAug 2011
- Primary completion24 Jan 2020
- Study completion24 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cervical Squamous Cell CarcinomaStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael M. Frumovitz, MD, MPH, Study chair, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01365156
- Sponsor's protocol ID
- 2010-0952
- Other IDs
- NCI-2011-02400
- Status last verified
- Jan 2021
- First submitted
- 1 Jun 2011
- Last updated
- 3 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Randomized Study of Pretherapeutic Para-aortic Lymphadenectomy in Women With Locally Advanced Cervical Cancer Dispositioned to Definitive Chemoradiotherapy
- ClinicalTrials.gov ID
- NCT01365156
- Acronym / sponsor ID
- 2010-0952
- 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
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Aug 2011 (actual)
- Primary completion
- 24 Jan 2020 (actual)
- Study completion
- 24 Jan 2020 (actual)
- First posted
- 3 Jun 2011 (estimated)
- Results
- Posted 3 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EPLND + Chemoradiation | Experimental | Procedure: Extraperitoneal laparoscopic lymphadenectomy (EPLND), Radiation: ChemoradiationGroup 1: Extraperitoneal laparoscopic lymphadenectomy followed by chemoradiation therapy |
| Chemoradiation | Active comparator | Radiation: ChemoradiationGroup 2: standard-of-care chemoradiation therapy only |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Women with clinical stage IB2-IVA cervical squamous cell carcinoma, adenosquamous, or adenocarcinoma.
- Women with FDG-PET positive or indeterminate pelvic lymph nodes or indeterminate low common iliac nodes and negative paraaortic nodes.
- Women with planned treatment of primary definitive chemoradiation therapy.
- Patient information and written informed consent form signed.
- Age >/= 18 years old
Key exclusion criteria (13 listed)
- Women with stage IA or IB1 cancer.
- Women with prior radiotherapy to the pelvis or retroperitoneal surgery.
- Women with neuroendocrine histologies, or histologies other than squamous, adenosquamous or adenocarcinoma.
- Women with FDG PETpositive high common or paraaortic lymph node metastasis confirmed by biopsy.
- Women who have undergone simple or radical hysterectomy prior to radiotherapy.
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 lymphadenectomy (EPLND)Also: Laparoscopic Extraperitoneal lymphadenectomy, Extraperitoneal Para-aortic Lymph Node Dissection, EPLNDLaparoscopic surgical procedure to remove and examine lymph nodes in abdomen, 7-10 days before chemoradiation treatment | Procedure or surgery | EPLND + Chemoradiation |
| ChemoradiationRadiation 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. | Radiation | Chemoradiation, EPLND + Chemoradiation |
Primary outcome
Overall Survival Rate
Time frame: 3 years
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- University of Texas MD Anderson Cancer Center WebsiteLink 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.
Michael M. Frumovitz, MD, MPH study chair
M.D. Anderson Cancer Center
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Extraperitoneal laparoscopic lymphadenectomy (EPLND) and Chemoradiation in people with Cervical Squamous Cell Carcinoma and Adenosquamous Carcinoma, run by M.D. Anderson Cancer Center at 3 sites in 2 countries.
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 7 inclusion and 13 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 3 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Belgium. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Overall Survival Rate (time frame: 3 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 3 Feb 2021; AzTrials last refreshed its copy on 26 Oct 2026.