MedTrace Logo

Central Neck Dissection in Patients With Clinical Node Negative Thyroid Cancer

NCT02138214 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 117

Last updated 2020-12-21

Study results available
· View outcomes & findings →

Summary

This phase II trial studies how well thyroid gland removal with or without central lymph node dissection works in treating patients with thyroid cancer or suspected thyroid cancer that has not spread to the lymph nodes (randomized into Arms I and II). Arms I and II are compared to a standard of care (SOC) Arm III to enable comparison of quality of life among various surgical treatments. Currently, the standard treatment for thyroid cancer is total thyroidectomy, or complete removal of the thyroid. The lymph nodes in the central part of the neck may also be surgically removed, called central lymph node dissection. Prophylactic removal of the lymph nodes may increase the risk of life-threatening complications, and may reduce post-surgery quality of life. It may also prevent the cancer from returning and reduce the need for additional surgery. It is not yet known whether recurrence rates and complication levels are lower after thyroid gland removal alone or with central lymph node dissection.

Conditions

  • Stage I Papillary Thyroid Cancer
  • Stage II Papillary Thyroid Cancer
  • Stage III Papillary Thyroid Cancer

Interventions

PROCEDURE

Thyroidectomy

Undergo total thyroidectomy

PROCEDURE

entral lymph node dissection (CLND)

Undergo total thyroidectomy with ipsilateral prophylactic CND

OTHER

Quality-of-life assessment

Voice evaluation, interviews, ancillary studies

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • University of Wisconsin, Madison

    lead OTHER

Principal Investigators

  • Rebecca Sippel · University of Wisconsin, Madison

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
73 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-06
Primary Completion
2019-10-30
Completion
2020-10-26

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02138214 on ClinicalTrials.gov