Cervical CancerNCT00595725
Intra-Operative Lymphatic Mapping in Patients With Invasive Carcinoma of the Cervix or Endometrial Carcinoma
A study testing Lymphatic Mapping in people with Cervical Cancer and Endometrial Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to learn if a surgical technique called intraoperative lymphatic mapping can accurately identify the lymph node that is at greatest risk if endometrial or cervical cancer spreads to the lymph nodes. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cervical Cancer, Endometrial Cancer, Cervical Carcinoma
- What is being tested?
- Lymphatic Mapping
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 151 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2003to Sep 2011
- Phase
- Interventional
- 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
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with endometrial cancer diagnosed on endometrial biopsy or dilatation and curettage.
- Patients with invasive cervical cancer diagnosed on cervical biopsy or cone biopsy.
- Patients with a performance status of 0, 1, 2, or 3 by the Gynecologic Oncology Group criteria (Appendix).
- Patients with stage I to ~IIA invasive cervical cancer disease according to the International Federation of Gynecology and Obstetrics (FIGO) clinical staging criteria (Appendix).
- Patients with clinical stage I endometrial cancer
- Patients who will undergo surgery to include a hysterectomy, radical hysterectomy and/or radical trachelectomy and bilateral lymphadenectomy via laparotomy or laparoscopy
- Patients who have signed an approved informed consent.
Who cannot join
- Patients with history of prior pelvic or para-aortic lymphadenectomy.
- Patients with stage IIB-IV invasive cervical cancer by FIGO criteria.
- Patients with recurrent endometrial or cervical cancer.
- Patients with prior pelvic radiation.
- Any patient with endometrial or cervical cancer treated with neoadjuvant chemotherapy and radiation therapy.
- Patients with a performance score of 4 by the Gynecologic Oncology Group criteria or who are not good surgical candidates (Appendix).
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- Patients with grossly infected primary tumors.
- Patients with known allergy to triphenyl-ethane compounds.
- Patients with known deficiency of Glucose-G-Phosphate Dehydrogenase.
- Patients with known Hemolytic Anemia from Pyruvate Kinase and G6PD Deficiencies.
- Severe Renal Disease.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
The purpose of this study is to learn if a surgical technique called intraoperative lymphatic mapping can accurately identify the lymph node that is at greatest risk if endometrial or cervical cancer spreads to the lymph nodes.
Early cervical cancer is usually treated by removing the cervix, tissue around the cervix, and the upper vagina. If needed, the uterus is also removed. The treatment also includes removing lymph nodes from the pelvis. Endometrial cancer is usually treated by removing the cervix, uterus, fallopian tubes and ovaries.
The treatment also includes removing lymph nodes from the pelvis.
Read the detailed description
Patients with FIGO stage I endometrial cancer or patients with FIGO stage I-IIA invasive cervical cancer and who will be undergoing surgical management to include a lymphadenectomy.
↓ Injection of radioisotope and preoperative lymphoscintigraphy with Tc99m either the day before or on the day of surgery by the Nuclear Medicine Department.
↓ Intraoperative lymphatic mapping with blue dye and gamma probe.
↓ Hysterectomy, Radical hysterectomy and/or radical trachelectomy and pelvic lymphadenectomy.
- Conditions
- Cervical Cancer, Endometrial Cancer, Cervical Carcinoma
- Being tested
- Lymphatic Mapping
- Keywords
- Cervix, Endometrium, Cervical Carcinoma, Lymphatic Mapping
- Medical subject headings
- Uterine Cervical Neoplasms, Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lymphatic MappingOther
Intra-Operative Lymphatic Mapping
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Other: Lymphatic Mapping |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the feasibility of identifying the sentinel lymph node in patients with endometrial and invasive cervical cancer using a combination of radioisotope and blue dye.
Measured: 7 years
Secondary outcomes (2)
To determine the feasibility of locating sentinel nodes in the pelvis and/or paraaortic region with preoperative lymphoscintigraphy.
Measured: 7 years
To document the location of the sentinel nodes in patients with invasive cervical cancer.
Measured: 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2008 (estimated)
- Study startFeb 2003
- Primary completionSep 2011
- Study completionSep 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 Memorial Sloan Kettering 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mary Gemignani, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00595725
- Sponsor's protocol ID
- 02-127
- Status last verified
- Sep 2011
- First submitted
- 7 Jan 2008
- Last updated
- 8 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-Operative Lymphatic Mapping in Patients With Invasive Carcinoma of the Cervix or Endometrial Carcinoma
- ClinicalTrials.gov ID
- NCT00595725
- Acronym / sponsor ID
- 02-127
- Conditions
- Cervical Cancer, Endometrial Cancer, Cervical Carcinoma
- Keywords
- Cervix, Endometrium, Cervical Carcinoma, Lymphatic Mapping
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- Feb 2003
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 16 Jan 2008 (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.
The purpose of this study is to learn if a surgical technique called intraoperative lymphatic mapping can accurately identify the lymph node that is at greatest risk if endometrial or cervical cancer spreads to the lymph nodes.
Early cervical cancer is usually treated by removing the cervix, tissue around the cervix, and the upper vagina. If needed, the uterus is also removed. The treatment also includes removing lymph nodes from the pelvis. Endometrial cancer is usually treated by removing the cervix, uterus, fallopian tubes and ovaries.
The treatment also includes removing lymph nodes from the pelvis.
Detailed description
Patients with FIGO stage I endometrial cancer or patients with FIGO stage I-IIA invasive cervical cancer and who will be undergoing surgical management to include a lymphadenectomy.
↓ Injection of radioisotope and preoperative lymphoscintigraphy with Tc99m either the day before or on the day of surgery by the Nuclear Medicine Department.
↓ Intraoperative lymphatic mapping with blue dye and gamma probe.
↓ Hysterectomy, Radical hysterectomy and/or radical trachelectomy and pelvic lymphadenectomy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: Lymphatic Mapping |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with endometrial cancer diagnosed on endometrial biopsy or dilatation and curettage.
- Patients with invasive cervical cancer diagnosed on cervical biopsy or cone biopsy.
- Patients with a performance status of 0, 1, 2, or 3 by the Gynecologic Oncology Group criteria (Appendix).
- Patients with stage I to ~IIA invasive cervical cancer disease according to the International Federation of Gynecology and Obstetrics (FIGO) clinical staging criteria (Appendix).
- Patients with clinical stage I endometrial cancer
Key exclusion criteria (11 listed)
- Patients with history of prior pelvic or para-aortic lymphadenectomy.
- Patients with stage IIB-IV invasive cervical cancer by FIGO criteria.
- Patients with recurrent endometrial or cervical cancer.
- Patients with prior pelvic radiation.
- Any patient with endometrial or cervical cancer treated with neoadjuvant chemotherapy and radiation therapy.
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 |
|---|---|---|
| Lymphatic MappingIntra-Operative Lymphatic Mapping | Other | 1 |
Primary outcome
To determine the feasibility of identifying the sentinel lymph node in patients with endometrial and invasive cervical cancer using a combination of radioisotope and blue dye.
Time frame: 7 years
2 secondary outcomes
To determine the feasibility of locating sentinel nodes in the pelvis and/or paraaortic region with preoperative lymphoscintigraphy.
Time frame: 7 years
To document the location of the sentinel nodes in patients with invasive cervical cancer.
Time frame: 7 years
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 8 Sep 2011.
- Memorial Sloan-Kettering 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.
Mary Gemignani, MD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lymphatic Mapping in people with Cervical Cancer and Endometrial Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site 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 7 inclusion and 11 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 8 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
To determine the feasibility of identifying the sentinel lymph node in patients with endometrial and invasive cervical cancer using a combination of radioisotope and blue dye. (time frame: 7 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 8 Sep 2011.