NCT02138214

Central Neck Dissection in Patients With Clinical Node Negative Thyroid Cancer

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 117 (actual)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: All
• Age: 21 Years – 73 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVES: I. To determine the rate of transient and permanent hypocalcemia SECONDARY OBJECTIVES: I. To determine the rate of voice and swallowing problems. II. To determine the degree to which quality of life (QOL) is compromised. III. To determine the degree to which accurate quality of life measures can be extracted from patient interview narratives using natural language processing techniques. IV. To determine clinical recurrence rates. OUTLINE: Patients are randomized to 1 of 2 treatment arms, if ineligible into a SOC arm. Arm I: Patients undergo total thyroidectomy alone. Arm II: Patients undergo total thyroidectomy with ipsilateral prophylactic central neck dissection (CND). Arm III: Patients ineligible to be randomized into Arm I or II, Standard of Care (SOC) comparator receiving same follow up. After completion of study treatment, patients are followed up at day 1, 2 and 6 weeks, and 6 and 12 months.

Conditions

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2014-06-06
• Primary completion: 2019-10-30
• Completion: 2020-10-26
• First posted: 2014-05-14
• Last updated: 2020-12-21
• Results posted: 2020-12-21

Locations

1 site across 1 country: United States