Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information
Lymph Node Mapping and Sentinel Lymph Node Identification in Patients With Stage IB1 Cervical Cancer
| Phase | Type | Status | Age | Sponsor | Protocol IDs |
|---|---|---|---|---|---|
| No phase specified | Diagnostic, Treatment | Completed | Not specified | NCI | GOG-0206 NCT00070317 |
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.
- Determine the false-negative predictive value of the sentinel lymph node in the determination of lymph node metastases in these patients.
Entry Criteria
Disease Characteristics:
- 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
Prior/Concurrent Therapy:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- No prior pelvic irradiation
Surgery
- 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
Patient Characteristics:
Age
- Not specified
Performance status
- Not specified
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
- Not specified
Other
- No known allergy to triphenylmethane compounds
Expected Enrollment
590A total of 295-590 patients will be accrued for this study within 18-36 months.
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.
Trial Lead Organizations
Gynecologic Oncology Group
 | | | ||
| Charles Levenback, MD, Protocol chair | |
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| Registry Information | ||
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| Official Title | Lymphatic Mapping And Sentinel Node Identification In Patients With Cervical Cancer | |
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| Trial Start Date | 2004-07-07 | |
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| Trial Completion Date | 2010-12-20 | |
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| Registered in ClinicalTrials.gov | NCT00070317 | |
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| Date Submitted to PDQ | 2003-08-27 | |
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| Information Last Verified | 2008-07-23 | |
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| NCI Grant/Contract Number | CA27469 | |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.
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