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| Sponsors and Collaborators: |
Gynecologic Oncology Group National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00070317 |
Purpose
RATIONALE: 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.
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.
| Condition | Intervention |
|---|---|
|
Cervical Cancer |
Drug: isosulfan blue Drug: methylene blue Procedure: conventional surgery Procedure: laparoscopic surgery Procedure: lymphangiography Procedure: radionuclide imaging Procedure: sentinel lymph node biopsy Radiation: technetium Tc 99m sulfur colloid |
| Study Type: | Interventional |
| Study Design: | Diagnostic, Open Label |
| Official Title: | Lymphatic Mapping And Sentinel Node Identification In Patients With Cervical Cancer |
| Estimated Enrollment: | 590 |
| Study Start Date: | July 2004 |
| Estimated Primary Completion Date: | January 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
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.
PROJECTED ACCRUAL: A total of 295-590 patients will be accrued for this study within 18-36 months.
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of carcinoma of the cervix of 1 of the following cellular types:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Contacts and Locations
Show 36 Study Locations| Study Chair: | Charles Levenback, MD | M.D. Anderson Cancer Center |
More Information
| Study ID Numbers: | CDR0000331918, GOG-0206 |
| Study First Received: | October 3, 2003 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00070317 History of Changes |
| Health Authority: | United States: Federal Government |
|
cervical adenocarcinoma cervical adenosquamous cell carcinoma cervical squamous cell carcinoma stage I cervical cancer |
|
Epidermoid Carcinoma Squamous Cell Carcinoma Adenocarcinoma Carcinoma, Squamous Cell |
Carcinoma, Adenosquamous Methylene Blue Carcinoma |
|
Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Pharmacologic Actions Methylene Blue |
