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Lymph Node Mapping and Sentinel Lymph Node Identification in Patients With Stage IB1 Cervical Cancer
This study has been terminated.
Sponsor:
Gynecologic Oncology Group
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT00070317
First received: October 3, 2003
Last updated: June 3, 2015
Last verified: June 2015
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Purpose
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.
| Condition | Intervention |
|---|---|
| Cervical Adenocarcinoma Cervical Adenosquamous Carcinoma Cervical Squamous Cell Carcinoma Stage I Cervical Cancer | 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 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Lymphatic Mapping and Sentinel Node Identification in Patients With Stage1B1 Cervical Carcinoma |
Resource links provided by NLM:
Further study details as provided by Gynecologic Oncology Group:
Primary Outcome Measures:
- Sensitivity, defined as the proportion of patients who test as SN (+) among the patients who have LN metastases (LN+) [ Time Frame: At the time of surgery ]The confidence interval of the sensitivity will be calculated by appropriate method.
Secondary Outcome Measures:
- Success rate of SN identification [ Time Frame: Up to 8 years ]
| Enrollment: | 102 |
| Study Start Date: | June 2004 |
| Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 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.
|
Drug: Isosulfan Blue
Undergo lymphangiography using isosulfan blue or methylene blue
Other Names:
Procedure: Lymph Node Mapping
Undergo lymphatic mapping
Other Name: lymphatic mapping
Procedure: Lymphangiography
Undergo lymphangiography using isosulfan blue or methylene blue
Other Name: Lymphography
Drug: Methylene Blue
Undergo lymphangiography using isosulfan blue or methylene blue
Other Names:
Procedure: Radionuclide Imaging
Undergo radionuclide imaging with technetium Tc 99m sulfur colloid
Other Names:
Procedure: Sentinel Lymph Node Biopsy
Undergo complete pelvic and low para-aortic lymphadenectomy
Other Names:
Radiation: Technetium Tc-99m Sulfur Colloid
Undergo radionuclide imaging with technetium Tc 99m sulfur colloid
Other Names:
Procedure: Therapeutic Conventional Surgery
Undergo radical hysterectomy
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | Child, Adult, Senior |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
-
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
- 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
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00070317
Please refer to this study by its ClinicalTrials.gov identifier: NCT00070317
Locations
| United States, Pennsylvania | |
| Gynecologic Oncology Group | |
| Philadelphia, Pennsylvania, United States, 19103 | |
Sponsors and Collaborators
Gynecologic Oncology Group
National Cancer Institute (NCI)
Investigators
| Principal Investigator: | Charles Levenback | Gynecologic Oncology Group |
More Information
| 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 ) |
| Study First Received: | October 3, 2003 |
| Last Updated: | June 3, 2015 |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Squamous Cell Adenocarcinoma Uterine Cervical Neoplasms Carcinoma, Adenosquamous Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Squamous Cell Uterine Neoplasms Genital Neoplasms, Female |
Urogenital Neoplasms Neoplasms by Site Uterine Cervical Diseases Uterine Diseases Genital Diseases, Female Neoplasms, Complex and Mixed Methylene Blue Technetium Tc 99m Sulfur Colloid Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Radiopharmaceuticals |
ClinicalTrials.gov processed this record on July 21, 2017