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



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

For Condition: cervical adenosquamous cell carcinoma,stage 1 cervical cancer,cervical adenocarcinoma,cervical squamous cell carcinoma
Status: Not yet recruiting
Sponsor(s): Gynecologic Oncology Group , National Cancer Institute (NCI)
Synopsis: 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 nodemetastases in patients who have cervical cancer. PURPOSE: Diagnostic trial to study the effectiveness of lymph node mapping and sentinel lymph node identification before and during surgery in detecting lymph node metastases in patients who have stage IB1 cervical cancer.
Details: OBJECTIVES: - Determine the sensitivity of the sentinel lymph node in the determination of lymph node metastases, using combined preoperative and 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. OUTLINE: This is a multicenter study. Prior to surgery, patients receive radiolabeled technetium Tc 99m sulfur colloid injected around the tumor and then undergo lymphoscintigraphy. Patients 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 250-500 patients will be accrued for this study within 16-32 months.
Eligibility:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol 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 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 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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
CharlesLevenback,  Study Chair,  M.D. Anderson Cancer Center


Additional Information:
Study ID Numbers:  CDR0000331918;  GOG-0206
Study Start Date: 
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00070317

Other Stage 1 Cervical Cancer Studies:
1. Oxaliplatin and Paclitaxel in Treating Patients With Locally Recurrent or Metastatic Cervical Cancer

2. Surgery and Vaccine Therapy in Treating Patients With Early Cervical Cancer

3. Gemcitabine in Treating Patients With Persistent or Recurrent Cancer of the Cervix

4. Bryostatin-1 Plus Cisplatin in Treating Patients With Recurrent or Advanced Cancer of the Cervix

5. Comparison of Three Chemotherapy Regimens in Treating Patients With Stage IVB, Recurrent, or Persistent Cervical Cancer

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