Sentinel Node Detection in Cervical Cancer

Sentinel Lymph Node Biopsy Clinical Trial

— SLNcxca  

Official title:

Sentinel Node Detection in Cervical Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03680833
• Other study ID #: RegionSkaneKKLund2
• Status: Recruiting
• Phase: N/A
• Start date: June 15, 2014
• Est. completion date: December 2021

Study information

• Verified date: September 2018
• Source: Region Skane
• Contact: Jan Persson, ass professor
• Phone: +46733522080
• Email: jan.persson[@]med.lu.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Evaluation of sensitivity of Sentinel lymph nodes for detecting nodal metastases in cervical cancer

Description:

Consecutive women with stage 1a2-2a1 cervical cancer scheduled for surgery will be approached for eligibility by defined criteria.

Sentinel nodes will be detected by a combined use of Indocyanine green and Tc99 radiocolloid ( first 75 patients) and for the continuation with either the combined use or the best performing of those tracers.

Technical success rates, adverse events (related study intervention and overall) sensitivity and negative predictive values will be estimated.

An interim analyse will be performed after 34 node positive patients based on the Fleming two stage analyse. The null hypothesis of sensitivity of 85% will be tested against an estimated sensitivity of 95%. At this stage the study may be closed for futility, closed as hull hypothesis is rejected or continued to reach another 28 node positive patients.

As a full pelvic lymphadenectomy will be performed after detection of sentinel nodes patient will act ast their own controls.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 226
• Est. completion date: December 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Women of age 18 years and older at the time of informed consent.

• Women with a pathologically proven cervical carcinoma of any histologic subtype, clinically stage 1a2- 2a1 planned for primary surgery

• Absence of any exclusion criteria

Exclusion Criteria:

• Non consenting patients

• Ongoing pregnancy

• Inability to understand written and/or oral study information

• Who performance status III or more

• Previous lower limb lymphedema

• Surgical contraindication to a laparoscopic approach or lymphadenectomy at surgeons discretion.

• Anesthesiologic contraindication to a laparoscopic approach at the anesthetist's discretion

• Locally advanced disease or intraabdominal/distant metastases at preoperative CT, MRI or ultrasonography

• Radiologically suspect pelvic nodal metastatic disease according to the RECIST criteria (>= 1 node with >=16 mm short axis diameter)

• Allergy to Iodine

• Patients with a known liver disease

• Patients with a significant bleeding disorder or mandatory antithrombotic treatment.

Related Conditions & MeSH terms

• Sentinel Lymph Node Biopsy
• Uterine Cervical Neoplasms

Intervention

Procedure:
• Sentinel node detection in cervical cancer
The study intervention is the injection of tracer followed by detection and removal of sentinel lymph nodes

Locations

Country	Name	City	State
Sweden	Department of Gynecology and Obstetrics	Lund

Sponsors (1)

Lead Sponsor	Collaborator
Region Skane

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sentinel node detection in cervical cancer; Sensitivity and negative predictive values for identifying pelvic nodal disease, See detailed study protocol	Detection of Sentinel nodes followed by full pelvic lymphadenectomy	4-5 years