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

Cervical Adenocarcinoma Clinical Trial

Official title:

Lymphatic Mapping and Sentinel Node Identification in Patients With Stage1B1 Cervical Carcinoma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00070317
• Other study ID #: GOG-0206
• Secondary ID: NCI-2012-02559CD
• Status: Terminated
• Phase: N/A
• First received: October 3, 2003
• Last updated: October 3, 2017
• Start date: June 2004
• Est. completion date: January 2013

Study information

• Verified date: June 2015
• Source: Gynecologic Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 102
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Carcinoma
• Carcinoma, Adenosquamous
• Carcinoma, Squamous Cell
• Cervical Adenocarcinoma
• Cervical Adenosquamous Carcinoma
• Cervical Squamous Cell Carcinoma
• Stage I Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Drug:
• Isosulfan Blue
Undergo lymphangiography using isosulfan blue or methylene blue

Procedure:
• Lymph Node Mapping
Undergo lymphatic mapping
• Lymphangiography
Undergo lymphangiography using isosulfan blue or methylene blue

Drug:
• Methylene Blue
Undergo lymphangiography using isosulfan blue or methylene blue

Procedure:
• Radionuclide Imaging
Undergo radionuclide imaging with technetium Tc 99m sulfur colloid
• Sentinel Lymph Node Biopsy
Undergo complete pelvic and low para-aortic lymphadenectomy

Radiation:
• Technetium Tc-99m Sulfur Colloid
Undergo radionuclide imaging with technetium Tc 99m sulfur colloid

Procedure:
• Therapeutic Conventional Surgery
Undergo radical hysterectomy

Locations

Country	Name	City	State
United States	Gynecologic Oncology Group	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Gynecologic Oncology Group	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity	Sensitivity is defined as the proportion of patients who test as positive sentinel node among the patients who have lymph node metastases.	At the time of surgery
Primary	False Negative Predictive Value (FNPV)	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	At the time of Surgery