Thyroid Gland Removal With or Without Central Lymph Node Dissection in Treating Patients With Node Negative Thyroid Cancer
Conditions
Stage I Papillary Thyroid Cancer - Stage II Papillary Thyroid Cancer - Stage III Papillary Thyroid Cancer
Conditions: official terms
Carcinoma - Thyroid Diseases - Thyroid Neoplasms
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Intervention
Name: thyroidectomy Type: Procedure
Name: thyroidectomy Type: Procedure
Name: central lymph node dissection Type: Procedure
Name: quality-of-life assessment Type: Procedure
Overall Status
Recruiting
Summary
This randomized 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. Currently, the standard treatment for thyroid cancer is total thyroidectomy, or complete removal of the thyroid. Sometimes, 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 clinical recurrence rates.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients undergo total thyroidectomy alone.

ARM II: Patients undergo total thyroidectomy with ipsilateral prophylactic central neck dissection (CND).

After completion of study treatment, patients are followed up at day 1, 2 and 6 weeks, and 6 and 12 months.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 70 Years
Minimum Age: 21 Years
Gender: Both
Criteria: Inclusion Criteria:

- Pre-operative diagnosis or suspicion of papillary thyroid cancer, usually by fine needle aspiration (FNA)

- No pre-operative evidence of cervical lymph node metastases on neck ultrasound

- No evidence of distant metastases (minimum of a negative complete x-ray [CXR])

- Ability to read and write in English

Exclusion Criteria:

- Largest papillary thyroid carcinoma < 1 cm in size on ultrasound

- Previous thyroid surgery

- Concurrent active malignancy of another type

- Inability to give informed consent or lacks decision making capacity

- T4 tumor

- Pre-existing vocal cord paralysis

- Chronic neurologic condition which affects voice or swallow (for instance, multiple sclerosis or Parkinson disease)

- Baseline laryngeal pathology that would warrant intervention that could affect voice or swallow function

- Becomes pregnant before surgery or at any time while on study

- Does not want radioactive iodine

- INTRA-OPERATION EXCLUSION CRITERIA

- Evidence of nodal involvement identified in the operating room (OR)

- Failure to confirm diagnosis of cancer in participant
Location
University of Wisconsin
Madison, Wisconsin, United States
Status: Recruiting
Contact: Rebecca S. Sippel - sippel@surgery.wisc.edu
Start Date
June 2014
Sponsors
University of Wisconsin, Madison
Source
University of Wisconsin, Madison
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page