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

Tracking Information

First Received Date ^ICMJE

October 3, 2003

Last Updated Date

February 6, 2009

Start Date ^ICMJE

July 2004

Estimated Primary Completion Date

January 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00070317 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Lymphatic Mapping And Sentinel Node Identification In Patients With Cervical Cancer

Brief Summary

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.

Detailed Description

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.

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.

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Diagnostic, Open Label

Condition ^ICMJE

Cervical Cancer

Intervention ^ICMJE

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 Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

590

Completion Date

Estimated Primary Completion Date

January 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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
Prior cone biopsy allowed provided current disease is stage IB1

Gender

Female

Ages

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Canada, Spain

Administrative Information

NCT ID ^ICMJE

NCT00070317

Responsible Party

Study ID Numbers ^ICMJE

CDR0000331918, GOG-0206

Study Sponsor ^ICMJE

Gynecologic Oncology Group

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Study Chair:

Charles Levenback, MD

M.D. Anderson Cancer Center

Information Provided By

National Cancer Institute (NCI)

Verification Date

July 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP