Phase 2 N=90 Randomized Double-blind Treatment

Central Neck Dissection in Patients With Clinical Node Negative Thyroid Cancer

Stage I Papillary Thyroid Cancer · Stage II Papillary Thyroid Cancer · Stage III Papillary Thyroid Cancer

Bottom Line

View on ClinicalTrials.gov: NCT02138214 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2020

Primary outcome: Primary: Percentage of Participants With Transient Hypoparathyroidism, as Defined by a Day 1 Serum Parathyroid Hormone (PTH) Level of < 10 pg/ml — 24.1; 33.3 percentage of participants — p=0.567

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Thyroidectomy (Procedure); entral lymph node dissection (CLND) (Procedure); Quality-of-life assessment (Other)
Age: Adult, Older Adult · 21+ yrs
Sex: All
Sponsor: University of Wisconsin, Madison
Primary completion: Oct 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants With Transient Hypoparathyroidism, as Defined by a Day 1 Serum Parathyroid Hormone (PTH) Level of < 10 pg/ml	24.1; 33.3	0.567
PRIMARY Post-operative Serum Calcium (mg/dL) at Day 12	9.39; 9.13	0.110
PRIMARY Total Calcium Consumption in First 2 Weeks	21876.63; 25470.19	—
PRIMARY Number of Participants With Hypocalcemia Symptoms in First 2 Weeks	8; 6	0.758
PRIMARY Hypocalcemia Symptom Severity Scale (Range of 1-5)	3; 2.50; 3.36; 1.42	—
PRIMARY Percentage of Participants That Required Calcium and Calcitriol at Month 6	0; 3	0.236
PRIMARY Post-operative Serum PTH (pg/ml) at Month 6	45.62; 44.24	0.759
PRIMARY Post-operative Serum Calcium Level at Month 6	9.12; 8.98	0.400
SECONDARY Rate of Transient and Permanent Hypocalcemia	—	—
SECONDARY Rate of Voice and Swallowing Problems	—	—
SECONDARY Degree to Which Quality of Life (QOL) is Compromised	—	—
SECONDARY Clinical Recurrence Rates	—	—
SECONDARY Degree to Which Accurate Quality of Life (QOL) Measures Can be Extracted From Patient Interview Narratives Using Natural Language Processing Techniques	—	—

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02138214). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.