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| ID | Type | Description | Link |
|---|---|---|---|
| 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 | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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.
OBJECTIVES:
I. 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Isosulfan Blue | Drug | Undergo lymphangiography using isosulfan blue or methylene blue |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity | Sensitivity is defined as the proportion of patients who test as positive sentinel node among the patients who have lymph node metastases. | 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 | At the time of Surgery |
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Inclusion Criteria:
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
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
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| Name | Affiliation | Role |
|---|---|---|
| Charles Levenback | Gynecologic Oncology Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gynecologic Oncology Group | Philadelphia | Pennsylvania | 19103 | United States |
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This trial was opened to patient entry on June 21, 2004 and was closed to entry July 21, 2008.
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| ID | Title | Description |
|---|---|---|
| FG000 | Radionuclide and Isosulfan Blue Injection | 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Lymph Node Mapping | Procedure | Undergo lymphatic mapping |
|
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| Lymphangiography | Procedure | Undergo lymphangiography using isosulfan blue or methylene blue |
|
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| Methylene Blue | Drug | Undergo lymphangiography using isosulfan blue or methylene blue |
|
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| Radionuclide Imaging | Procedure | Undergo radionuclide imaging with technetium Tc 99m sulfur colloid |
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| Sentinel Lymph Node Biopsy | Procedure | Undergo complete pelvic and low para-aortic lymphadenectomy |
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| Technetium Tc-99m Sulfur Colloid | Radiation | Undergo radionuclide imaging with technetium Tc 99m sulfur colloid |
|
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| Therapeutic Conventional Surgery | Procedure | Undergo radical hysterectomy |
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| COMPLETED |
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| NOT COMPLETED |
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Eligible and evaluable patients
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| ID | Title | Description |
|---|---|---|
| BG000 | Diagnostic | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Sensitivity | Sensitivity is defined as the proportion of patients who test as positive sentinel node among the patients who have lymph node metastases. | Eligible and evaluable patients with lymph node metastasis and identified sentinel node | Posted | Number | 90% Confidence Interval | Percentage of participants | At the time of surgery |
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| Primary | 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 | Eligible and evaluable patients who tested as negative sentinel node and have lymph node sampling | Posted | Number | 90% Confidence Interval | Percentage of participants | At the time of Surgery |
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All treatment-related adverse events which occurred within 30 days of study surgical procedure are reported.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Diagnostic | 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 | 0 | 89 | 0 | 89 | 32 | 89 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hemoglobin | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Other Blood/Bone Marrow | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Neutrophils | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Cardiac | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Constitutional Symptoms | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dermatology/Skin | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Other Gastrointestinal | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Infection | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Lymphocele | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Other Lymphatics | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Metabolic/Laboratory | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Pain | General disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Renal/Genitourinary | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Intra-Op Injury: Ureter | Surgical and medical procedures | CTCAE (3.0) | Non-systematic Assessment |
| |
| Thrombosis/Thrombus/Embolism | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Linda Gedeon for Wei Deng, PhD. | NRG Oncology | 716-845-1169 | lgedeon@gogstats.org |
| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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| ID | Term |
|---|---|
| C025484 | iso-sulfan blue |
| C008769 | sulfan blue |
| D008751 | Methylene Blue |
| D021701 | Sentinel Lymph Node Biopsy |
| D013671 | Technetium Tc 99m Sulfur Colloid |
| ID | Term |
|---|---|
| D010640 | Phenothiazines |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D001706 | Biopsy |
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D013048 | Specimen Handling |
| D003949 | Diagnostic Techniques, Surgical |
| D013514 | Surgical Procedures, Operative |
| D008197 | Lymph Node Excision |
| D008919 | Investigative Techniques |
| D007287 | Inorganic Chemicals |
| D017556 | Technetium Compounds |
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| Title | Measurements |
|---|---|
|
| 50-59 years |
|
| 60-69 years |
|
| 70-79 years |
|
| 80-89 years |
|
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Counts |
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| Participants |
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