Cervical AdenocarcinomaNCT00070317
Lymph Node Mapping and Sentinel Lymph Node Identification in Patients With Stage IB1 Cervical Cancer
A study testing Isosulfan Blue, Lymph Node Mapping and Lymphangiography in people with Cervical Adenocarcinoma and Cervical Adenosquamous Carcinoma, run by Gynecologic Oncology Group at 1 site in United States.
Trial summary
This clinical trial is studying how well lymph node mapping and sentinel lymph node identification work in finding lymph node metastases in patients with stage IB1 cervical cancer. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Cervical Adenocarcinoma, Cervical Adenosquamous Carcinoma, Cervical Squamous Cell Carcinoma
- What is being tested?
- Isosulfan Blue, Lymph Node Mapping and Lymphangiography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2004to Jan 2013
- Phase
- Interventional
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of carcinoma of the cervix of 1 of the following cellular types:
- Squamous cell carcinoma
- Adenocarcinoma
- Adenosquamous cell carcinoma
- Stage IB1 disease (no greater than 4 cm)
- No unequivocal evidence of metastases
Show all 12Show fewer
- Adequate surgical candidate
- No known allergy to triphenylmethane compounds
- No prior pelvic irradiation
- No prior retroperitoneal surgery
- More than 4 weeks since prior cold knife or loop electrosurgical excision procedure (LEEP) cone biopsy
- Prior cone biopsy allowed provided current disease is stage IB1
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Gynecologic Oncology Group
Philadelphia, Pennsylvania, 19103
About this study
Official title: Lymphatic Mapping and Sentinel Node Identification in Patients With Stage1B1 Cervical Carcinoma
This clinical trial is studying how well lymph node mapping and sentinel lymph node identification work in finding lymph node metastases in patients with stage IB1 cervical cancer. Diagnostic procedures, such as lymph node mapping and sentinel lymph node identification, performed before and during surgery, may improve the ability to detect lymph node metastases in patients who have cervical cancer.
Read the detailed description
OBJECTIVES:
- Determine the sensitivity of the sentinel lymph node in the determination of lymph node metastases, using preoperative or intraoperative lymphatic mapping, in patients with stage IB1 cervical cancer.
II. Determine the false-negative predictive value of the sentinel lymph node in the determination of lymph node metastases in these patients.
OUTLINE: This is a multicenter study.
Patients receive radiolabeled technetium Tc 99m sulfur colloid injected around the tumor 6 hours prior to or after induction of anesthesia right before surgery. Patients then undergo radical hysterectomy and complete pelvic and low para-aortic lymphadenectomy. Intraoperatively, patients undergo lymphatic mapping and sentinel lymph node identification using isosulfan blue or methylene blue injected at 4 locations in the cervix and a hand-held gamma counter.
- Conditions
- Cervical Adenocarcinoma, Cervical Adenosquamous Carcinoma, Cervical Squamous Cell Carcinoma, Stage I Cervical Cancer
- Being tested
- Isosulfan Blue, Lymph Node Mapping, Lymphangiography, Methylene Blue, Radionuclide Imaging
- 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.
Isosulfan BlueDrug
Also called Lymphazurin, N-[4-[(4-(diethylamino)phenyl)(2,5-disulfophenyl)methylene]-2,5-cyclohexadien-1-ylidene]-N-ethyl-ethanaminium hydroxide
Undergo lymphangiography using isosulfan blue or methylene blue
Lymph Node MappingProcedure or surgery
Also called lymphatic mapping
Undergo lymphatic mapping
LymphangiographyProcedure or surgery
Also called Lymphography
Undergo lymphangiography using isosulfan blue or methylene blue
Methylene BlueDrug
Also called Azul de Metileno, Azul Metile, Blu di Metilene, CI Basic Blue 9
Undergo lymphangiography using isosulfan blue or methylene blue
Radionuclide ImagingProcedure or surgery
Also called nuclear medicine scan, radioimaging, Radionuclide Scanning, Scan
Undergo radionuclide imaging with technetium Tc 99m sulfur colloid
Sentinel Lymph Node BiopsyProcedure or surgery
Also called Sentinel Node Biopsy, Sentinel node biopsy alone, SLNB, SNB
Undergo complete pelvic and low para-aortic lymphadenectomy
Technetium Tc-99m Sulfur ColloidRadiation
Also called Tc 99m Sulfur Colloid, Tc-99m SC, Technetium Tc 99m Sulfur Colloid
Undergo radionuclide imaging with technetium Tc 99m sulfur colloid
Therapeutic Conventional SurgeryProcedure or surgery
Undergo radical hysterectomy
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic | Experimental | Patients receive radiolabeled technetium Tc 99m sulfur colloid injected around the tumor 6 hours prior to or after induction of anesthesia right before surgery. Patients then undergo radical hysterectomy and complete pelvic and low para-aortic lymphadenectomy. Intraoperatively, patients undergo lymphatic mapping and sentinel lymph node identification using isosulfan blue or methylene blue injected at 4 locations in the cervix and a hand-held gamma counter. Receives: Drug: Isosulfan Blue; Procedure: Lymph Node Mapping; Procedure: Lymphangiography; Drug: Methylene Blue; Procedure: Radionuclide Imaging; Procedure: Sentinel Lymph Node Biopsy; Radiation: Technetium Tc-99m Sulfur Colloid; Procedure: Therapeutic Conventional Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity
Sensitivity is defined as the proportion of patients who test as positive sentinel node among the patients who have lymph node metastases.
Measured: At the time of surgery
False Negative Predictive Value (FNPV)
The proportion of patients with FNPV among patients who tests as negative sentinel node, where FNPV is defined as a person who tests as negative sentinel node but who actually has lymph node metastases
Measured: At the time of Surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2003 (estimated)
- Study startJun 2004
- Primary completionJan 2013
- Study completionJan 2013
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 AdenocarcinomaStudies of the same condition, open and under way.
- 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
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gynecologic Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Charles Levenback, Principal investigator, Gynecologic Oncology Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00070317
- Sponsor's protocol ID
- GOG-0206
- Other IDs
- NCI-2012-02559, CDR0000331918, GOG-0206, GOG-0206, U10CA027469
- Status last verified
- Jun 2015
- First submitted
- 3 Oct 2003
- Last updated
- 6 Nov 2017
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lymphatic Mapping and Sentinel Node Identification in Patients With Stage1B1 Cervical Carcinoma
- ClinicalTrials.gov ID
- NCT00070317
- Acronym / sponsor ID
- GOG-0206
- Conditions
- Cervical Adenocarcinoma, Cervical Adenosquamous Carcinoma, Cervical Squamous Cell Carcinoma, Stage I Cervical Cancer
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Gynecologic Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jun 2004
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 7 Oct 2003 (estimated)
- Results
- Posted 3 Oct 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial is studying how well lymph node mapping and sentinel lymph node identification work in finding lymph node metastases in patients with stage IB1 cervical cancer. Diagnostic procedures, such as lymph node mapping and sentinel lymph node identification, performed before and during surgery, may improve the ability to detect lymph node metastases in patients who have cervical cancer.
Detailed description
OBJECTIVES:
- Determine the sensitivity of the sentinel lymph node in the determination of lymph node metastases, using preoperative or intraoperative lymphatic mapping, in patients with stage IB1 cervical cancer.
II. Determine the false-negative predictive value of the sentinel lymph node in the determination of lymph node metastases in these patients.
OUTLINE: This is a multicenter study.
Patients receive radiolabeled technetium Tc 99m sulfur colloid injected around the tumor 6 hours prior to or after induction of anesthesia right before surgery. Patients then undergo radical hysterectomy and complete pelvic and low para-aortic lymphadenectomy. Intraoperatively, patients undergo lymphatic mapping and sentinel lymph node identification using isosulfan blue or methylene blue injected at 4 locations in the cervix and a hand-held gamma counter.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic | Experimental | Drug: Isosulfan Blue, Procedure: Lymph Node Mapping, Procedure: Lymphangiography, Drug: Methylene Blue, Procedure: Radionuclide Imaging, Procedure: Sentinel Lymph Node Biopsy, Radiation: Technetium Tc-99m Sulfur Colloid, Procedure: Therapeutic Conventional SurgeryPatients receive radiolabeled technetium Tc 99m sulfur colloid injected around the tumor 6 hours prior to or after induction of anesthesia right before surgery. Patients then undergo radical hysterectomy and complete pelvic and low para-aortic lymphadenectomy. Intraoperatively, patients undergo lymphatic mapping and sentinel lymph node identification using isosulfan blue or methylene blue injected at 4 locations in the cervix and a hand-held gamma counter. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- Diagnosis of carcinoma of the cervix of 1 of the following cellular types:
- Stage IB1 disease (no greater than 4 cm)
- No unequivocal evidence of metastases
- Adequate surgical candidate
- No known allergy to triphenylmethane compounds
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Isosulfan BlueAlso: Lymphazurin, N-[4-[(4-(diethylamino)phenyl)(2,5-disulfophenyl)methylene]-2,5-cyclohexadien-1-ylidene]-N-ethyl-ethanaminium hydroxideUndergo lymphangiography using isosulfan blue or methylene blue | Drug | Diagnostic |
| Lymph Node MappingAlso: lymphatic mappingUndergo lymphatic mapping | Procedure or surgery | Diagnostic |
| LymphangiographyAlso: LymphographyUndergo lymphangiography using isosulfan blue or methylene blue | Procedure or surgery | Diagnostic |
| Methylene BlueAlso: Azul de Metileno, Azul Metile, Blu di Metilene, CI Basic Blue 9Undergo lymphangiography using isosulfan blue or methylene blue | Drug | Diagnostic |
| Radionuclide ImagingAlso: nuclear medicine scan, radioimaging, Radionuclide Scanning, ScanUndergo radionuclide imaging with technetium Tc 99m sulfur colloid | Procedure or surgery | Diagnostic |
| Sentinel Lymph Node BiopsyAlso: Sentinel Node Biopsy, Sentinel node biopsy alone, SLNB, SNBUndergo complete pelvic and low para-aortic lymphadenectomy | Procedure or surgery | Diagnostic |
| Technetium Tc-99m Sulfur ColloidAlso: Tc 99m Sulfur Colloid, Tc-99m SC, Technetium Tc 99m Sulfur ColloidUndergo radionuclide imaging with technetium Tc 99m sulfur colloid | Radiation | Diagnostic |
| Therapeutic Conventional SurgeryUndergo radical hysterectomy | Procedure or surgery | Diagnostic |
Primary outcome
Sensitivity
Time frame: At the time of surgery
Sensitivity is defined as the proportion of patients who test as positive sentinel node among the patients who have lymph node metastases.
False Negative Predictive Value (FNPV)
Time frame: At the time of Surgery
The proportion of patients with FNPV among patients who tests as negative sentinel node, where FNPV is defined as a person who tests as negative sentinel node but who actually has lymph node metastases
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Charles Levenback principal investigator
Gynecologic Oncology Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Isosulfan Blue, Lymph Node Mapping and Lymphangiography in people with Cervical Adenocarcinoma and Cervical Adenosquamous Carcinoma, run by Gynecologic Oncology Group 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 12 inclusion and 0 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: stopped early, as of the sponsor's last update on 6 Nov 2017. 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?
Yes. Results are posted in the registry (first posted 3 Oct 2017). 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?
Sensitivity (time frame: At the time of surgery). The study lists 2 primary outcomes in all. 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 6 Nov 2017.