Central Neck Dissection in Patients With Clinical Node Negative Thyroid Cancer
Condition: Stage I Papillary Thyroid Cancer; Stage II Papillary Thyroid Cancer; Stage III Papillary Thyroid Cancer
MeSH terms: Thyroid Neoplasms; Thyroid Cancer, Papillary; Thyroid Diseases
Intervention: Thyroidectomy; entral lymph node dissection (CLND); Quality-of-life assessment
Intervention description: Undergo total thyroidectomy; Undergo total thyroidectomy with ipsilateral prophylactic CND; Voice evaluation, interviews, ancillary studies
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 117.0
Sex: All
Minimum age: 21 Years
Maximum age: 73 Years
Healthy volunteers: No

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.
    

Eligibility 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
             (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