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

This study has been terminated.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT00070317
First received: October 3, 2003
Last updated: June 3, 2015
Last verified: June 2015
  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. 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 Intervention
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

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Lymphatic Mapping and Sentinel Node Identification in Patients With Stage1B1 Cervical Carcinoma

Resource links provided by NLM:


Further study details as provided by Gynecologic Oncology Group:

Primary Outcome Measures:
  • Sensitivity, defined as the proportion of patients who test as SN (+) among the patients who have LN metastases (LN+) [ Time Frame: At the time of surgery ] [ Designated as safety issue: No ]
    The confidence interval of the sensitivity will be calculated by appropriate method.


Secondary Outcome Measures:
  • Success rate of SN identification [ Time Frame: Up to 8 years ] [ Designated as safety issue: No ]

Enrollment: 102
Study Start Date: June 2004
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00070317

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

Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT00070317     History of Changes
Other Study ID Numbers: GOG-0206  NCI-2012-02559  CDR0000331918  GOG-0206  GOG-0206  U10CA027469 
Study First Received: October 3, 2003
Last Updated: June 3, 2015
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on December 02, 2016