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

Study Description

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Brief Summary:

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 or disease	Intervention/treatment	Phase
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	Not Applicable

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	102 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Diagnostic
Official Title:	Lymphatic Mapping and Sentinel Node Identification in Patients With Stage1B1 Cervical Carcinoma
Study Start Date :	June 2004
Actual Primary Completion Date :	January 2013
Actual Study Completion Date :	January 2013

Arms and Interventions

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Arm

Intervention/treatment

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: Lymphazurin; N-[4-[(4-(diethylamino)phenyl)(2,5-disulfophenyl)methylene]-2,5-cyclohexadien-1-ylidene]-N-ethyl-ethanaminium hydroxide 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: Azul de Metileno; Azul Metile; Blu di Metilene; CI Basic Blue 9; CI-52015; Collubleu; Colour Index No. 52015; Desmoidpillen; Methylenum Caeruleum; Methylthioninii Chloridum; Methylthioninium Chloride; Schultz No. 1038; Tetramethylthionine Chloride Trihydrate; Urolene Blue; Vitableu Procedure: Radionuclide Imaging; Undergo radionuclide imaging with technetium Tc 99m sulfur colloid; Other Names: nuclear medicine scan; radioimaging; Radionuclide Scanning; Scan; SCINTIGRAPHY Procedure: Sentinel Lymph Node Biopsy; Undergo complete pelvic and low para-aortic lymphadenectomy; Other Names: Sentinel Node Biopsy; Sentinel node biopsy alone; SLNB; SNB Radiation: Technetium Tc-99m Sulfur Colloid; Undergo radionuclide imaging with technetium Tc 99m sulfur colloid; Other Names: Tc 99m Sulfur Colloid; Tc-99m SC; Technetium Tc 99m Sulfur Colloid Procedure: Therapeutic Conventional Surgery; Undergo radical hysterectomy

Outcome Measures

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Primary Outcome Measures :

1. Sensitivity [ Time Frame: At the time of surgery ]
   Sensitivity is defined as the proportion of patients who test as positive sentinel node among the patients who have lymph node metastases.
2. False Negative Predictive Value (FNPV) [ Time Frame: At the time of Surgery ]
   The proportion of patients with FNPV among patients who tests as negative sentinel node, where FNPV is defined as a person who tests as negative sentinel node but who actually has lymph node metastases

Eligibility Criteria

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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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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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 )
First Posted:	October 7, 2003
Results First Posted:	October 3, 2017
Last Update Posted:	November 6, 2017
Last Verified:	June 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