Central Neck Dissection in Patients With Clinical Node Negative Thyroid Cancer

University of Wisconsin (UW)

Status and phase: Completed; Phase 2

Conditions: Stage III Papillary Thyroid Cancer; Stage II Papillary Thyroid Cancer; Stage I Papillary Thyroid Cancer

Treatments: Procedure: Thyroidectomy; Procedure: entral lymph node dissection (CLND); Other: Quality-of-life assessment

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02138214

SMPH\SURGERY\SURGERY (Other Identifier)

UW13115 (Other Identifier)

A539700 (Other Identifier)

2014-0391 (Other Identifier)

NCI-2014-00833 (Registry Identifier)

R01CA176911 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 117 patients

Sex: All

Ages: 21 to 73 years old

Volunteers: No Healthy Volunteers

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 (randomization arms only)
• No evidence of distant metastases
• 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

INTRA-OPERATION EXCLUSION CRITERIA (randomization arms only)

• Evidence of nodal involvement identified in the operating room (OR)
• Failure to confirm diagnosis of cancer in participant

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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117 participants in 3 patient groups

Arm I (no CND)

Experimental group

Description:

Patients undergo total thyroidectomy alone.

Treatment:

Procedure: Thyroidectomy

Other: Quality-of-life assessment

Arm II (CND)

Experimental group

Description:

Patients undergo total thyroidectomy with ipsilateral prophylactic CND.

Treatment:

Procedure: Thyroidectomy

Other: Quality-of-life assessment

Procedure: entral lymph node dissection (CLND)

Arm III (SOC)

Active Comparator group

Description:

Patients who are not eligible for randomization into Arm I or Arm II, Standard of Care (SOC) group. No specific trial intervention, treated as per patient and physician preference

Treatment:

Other: Quality-of-life assessment