CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 117 enrolled
Drug / intervention
Thyroidectomy +2 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02138214
NCT02138214Phase 2Completed

Thyroid Gland Removal With or Without Central Lymph Node Dissection in Treating Patients With Node Negative Thyroid Cancer

University of Wisconsin, Madison·interventional·Posted May 14, 2014·Updated Dec 21, 2020

In Brief

A Phase 2 clinical trial evaluating Thyroidectomy, entral lymph node dissection (CLND), and 1 other intervention for Stage I Papillary Thyroid Cancer and 2 related conditions. Completed, enrolled 117 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedMay 14, 2014
Enrollment StartJun 6, 2014
Primary CompletionOct 30, 2019
Study CompletionOct 26, 2020
TodayJul 2, 2026
Enrollment to primary: 5.4 yearsPosted 12.1 years ago

Interventions

Thyroidectomyprocedure

Undergo total thyroidectomy

entral lymph node dissection (CLND)procedure

Undergo total thyroidectomy with ipsilateral prophylactic CND

Quality-of-life assessmentother

Voice evaluation, interviews, ancillary studies