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Lymph Node Mapping and Sentinel Lymph Node Identification in Patients With Stage IB1 Cervical Cancer

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ClinicalTrials.gov Identifier: NCT00070317
Recruitment Status : Terminated
First Posted : October 7, 2003
Results First Posted : October 3, 2017
Last Update Posted : November 6, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Gynecologic Oncology Group

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Conditions Cervical Adenocarcinoma
Cervical Adenosquamous Carcinoma
Cervical Squamous Cell Carcinoma
Stage I Cervical Cancer
Interventions 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
Enrollment 102
Recruitment Details This trial was opened to patient entry on June 21, 2004 and was closed to entry July 21, 2008.
Pre-assignment Details  
Arm/Group Title Radionuclide and Isosulfan Blue Injection
Hide Arm/Group Description

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.

Isosulfan Blue: Undergo lymphangiography using isosulfan blue or methylene blue Lymph Node Mapping: Undergo lymphatic mapping Lymphangiography: Undergo lymphangiography using isosulfan blue or methylene blue Methylene Blue: Undergo lymphangiography using isosulfan blue or methylene blue Radionuclide Imaging: Undergo radionuclide imaging with technetium Tc 99m sulfur colloid Sentinel Lymph Node Biopsy: Undergo complete pelvic and low para-aortic lymphadenectomy Technetium Tc-99m Sulfur Colloid: Undergo radionuclid

Period Title: Overall Study
Started 102
Completed 89
Not Completed 13
Reason Not Completed
Inevaluable (Never Treated)             1
Ineligible Wrong Cell type/primary/stage             3
Ineligible required test not done             1
Ineligible-Improper prior treatment             2
Ineligible-Inadequate pathology             6
Arm/Group Title Diagnostic
Hide Arm/Group Description

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.

Isosulfan Blue: Undergo lymphangiography using isosulfan blue or methylene blue Lymph Node Mapping: Undergo lymphatic mapping Lymphangiography: Undergo lymphangiography using isosulfan blue or methylene blue Methylene Blue: Undergo lymphangiography using isosulfan blue or methylene blue Radionuclide Imaging: Undergo radionuclide imaging with technetium Tc 99m sulfur colloid Sentinel Lymph Node Biopsy: Undergo complete pelvic and low para-aortic lymphadenectomy Technetium Tc-99m Sulfur Colloid: Undergo radionuclid

Overall Number of Baseline Participants 89
Hide Baseline Analysis Population Description
Eligible and evaluable patients
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 89 participants
20-29 years
6
   6.7%
30-39 years
23
  25.8%
40-49 years
31
  34.8%
50-59 years
17
  19.1%
60-69 years
9
  10.1%
70-79 years
2
   2.2%
80-89 years
1
   1.1%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 89 participants
Female
89
 100.0%
Male
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 89 participants
American Indian or Alaska Native
4
   4.5%
Asian
3
   3.4%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
3
   3.4%
White
75
  84.3%
More than one race
0
   0.0%
Unknown or Not Reported
4
   4.5%
1.Primary Outcome
Title Sensitivity
Hide Description Sensitivity is defined as the proportion of patients who test as positive sentinel node among the patients who have lymph node metastases.
Time Frame At the time of surgery
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and evaluable patients with lymph node metastasis and identified sentinel node
Arm/Group Title Diagnostic
Hide Arm/Group Description:

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.

Isosulfan Blue: Undergo lymphangiography using isosulfan blue or methylene blue Lymph Node Mapping: Undergo lymphatic mapping Lymphangiography: Undergo lymphangiography using isosulfan blue or methylene blue Methylene Blue: Undergo lymphangiography using isosulfan blue or methylene blue Radionuclide Imaging: Undergo radionuclide imaging with technetium Tc 99m sulfur colloid Sentinel Lymph Node Biopsy: Undergo complete pelvic and low para-aortic lymphadenectomy Technetium Tc-99m Sulfur Colloid: Undergo radionuclid

Overall Number of Participants Analyzed 21
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: Percentage of participants
85.7
(67 to 96)
2.Primary Outcome
Title False Negative Predictive Value (FNPV)
Hide Description 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
Time Frame At the time of Surgery
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and evaluable patients who tested as negative sentinel node and have lymph node sampling
Arm/Group Title Diagnostic
Hide Arm/Group Description:

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.

Isosulfan Blue: Undergo lymphangiography using isosulfan blue or methylene blue Lymph Node Mapping: Undergo lymphatic mapping Lymphangiography: Undergo lymphangiography using isosulfan blue or methylene blue Methylene Blue: Undergo lymphangiography using isosulfan blue or methylene blue Radionuclide Imaging: Undergo radionuclide imaging with technetium Tc 99m sulfur colloid Sentinel Lymph Node Biopsy: Undergo complete pelvic and low para-aortic lymphadenectomy Technetium Tc-99m Sulfur Colloid: Undergo radionuclid

Overall Number of Participants Analyzed 51
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: Percentage of participants
5.9
(2 to 15)
Time Frame All treatment-related adverse events which occurred within 30 days of study surgical procedure are reported.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Diagnostic
Hide Arm/Group Description

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.

Isosulfan Blue: Undergo lymphangiography using isosulfan blue or methylene blue Lymph Node Mapping: Undergo lymphatic mapping Lymphangiography: Undergo lymphangiography using isosulfan blue or methylene blue Methylene Blue: Undergo lymphangiography using isosulfan blue or methylene blue Radionuclide Imaging: Undergo radionuclide imaging with technetium Tc 99m sulfur colloid Sentinel Lymph Node Biopsy: Undergo complete pelvic and low para-aortic lymphadenectomy Technetium Tc-99m Sulfur Colloid: Undergo radionuclid

All-Cause Mortality
Diagnostic
Affected / at Risk (%)
Total   0/89 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Diagnostic
Affected / at Risk (%)
Total   0/89 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Diagnostic
Affected / at Risk (%)
Total   32/89 (35.96%) 
Blood and lymphatic system disorders   
Hemoglobin * 1  20/89 (22.47%) 
Other Blood/Bone Marrow * 1  1/89 (1.12%) 
Neutrophils * 1  1/89 (1.12%) 
Lymphocele * 1  1/89 (1.12%) 
Other Lymphatics * 1  1/89 (1.12%) 
Cardiac disorders   
Cardiac * 1  1/89 (1.12%) 
Gastrointestinal disorders   
Vomiting * 1  1/89 (1.12%) 
Nausea * 1  1/89 (1.12%) 
Other Gastrointestinal * 1  3/89 (3.37%) 
Diarrhea * 1  1/89 (1.12%) 
General disorders   
Constitutional Symptoms * 1  8/89 (8.99%) 
Pain * 1  6/89 (6.74%) 
Infections and infestations   
Infection * 1  4/89 (4.49%) 
Metabolism and nutrition disorders   
Metabolic/Laboratory * 1  2/89 (2.25%) 
Renal and urinary disorders   
Renal/Genitourinary * 1  3/89 (3.37%) 
Skin and subcutaneous tissue disorders   
Dermatology/Skin * 1  1/89 (1.12%) 
Surgical and medical procedures   
Intra-Op Injury: Ureter * 1  1/89 (1.12%) 
Vascular disorders   
Thrombosis/Thrombus/Embolism * 1  1/89 (1.12%) 
1
Term from vocabulary, CTCAE (3.0)
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Linda Gedeon for Wei Deng, PhD.
Organization: NRG Oncology
Phone: 716-845-1169
Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT00070317     History of Changes
Other Study ID Numbers: GOG-0206
NCI-2012-02559 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000331918
GOG-0206 ( Other Identifier: Gynecologic Oncology Group )
GOG-0206 ( Other Identifier: CTEP )
U10CA027469 ( U.S. NIH Grant/Contract )
First Submitted: October 3, 2003
First Posted: October 7, 2003
Results First Submitted: September 8, 2017
Results First Posted: October 3, 2017
Last Update Posted: November 6, 2017