Central Neck Dissection in Patients With Clinical Node Negative Thyroid Cancer
Completed · Phase 2
Conditions studied: Stage I Papillary Thyroid Cancer, Stage II Papillary Thyroid Cancer, Stage III Papillary Thyroid Cancer
In brief
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.
Key facts
- Study ID
- NCT02138214
- Run by
- University of Wisconsin, Madison
- People needed
- 117
- Starts
- 2014-06-06
- Expected to finish
- 2020-10-26
- Last updated by the study team
- 2020-12-21
Who can join
Age: 21 and older, up to 73. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University of Wisconsin — Madison, Wisconsin, United States
Full record on ClinicalTrials.gov
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