Clinical trial NCT02138214: Central Neck Dissection in Patients With Clinical Node Negative Thyroid Cancer
Official title: Thyroid Gland Removal With or Without Central Lymph Node Dissection in Treating Patients With Node Negative Thyroid Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Stage I Papillary Thyroid Cancer
Stage II Papillary Thyroid Cancer
Stage III Papillary Thyroid Cancer
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2014-05-14
Enrollment: 117
Sex: ALL
Minimum age (years): 21
Maximum age (years): 73
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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.

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

Primary outcomes:
measure: Percentage of Participants With Transient Hypoparathyroidism, as Defined by a Day 1 Serum Parathyroid Hormone (PTH) Level of < 10 pg/ml
timeFrame: Post-operative day 1
measure: Post-operative Serum Calcium (mg/dL) at Day 12
timeFrame: At day 12
measure: Total Calcium Consumption in First 2 Weeks
timeFrame: 2 weeks after surgery
measure: Number of Participants With Hypocalcemia Symptoms in First 2 Weeks
timeFrame: 2 weeks
measure: Hypocalcemia Symptom Severity Scale (Range of 1-5)
timeFrame: 2 weeks post surgery
measure: Percentage of Participants That Required Calcium and Calcitriol at Month 6
timeFrame: At Month 6
measure: Post-operative Serum PTH (pg/ml) at Month 6
timeFrame: At Month 6
measure: Post-operative Serum Calcium Level at Month 6
timeFrame: At Month 6
Secondary outcomes:
measure: Rate of Transient and Permanent Hypocalcemia
timeFrame: Post-operative day 1 - Month 6
measure: Rate of Voice and Swallowing Problems
timeFrame: Post operative day 1 - up to 1 year
measure: Degree to Which Quality of Life (QOL) is Compromised
timeFrame: Post-operative day 1 - up to 1 year
measure: Clinical Recurrence Rates
timeFrame: Week 6 - up to 5 years
measure: Degree to Which Accurate Quality of Life (QOL) Measures Can be Extracted From Patient Interview Narratives Using Natural Language Processing Techniques
timeFrame: Post-operative day 1 - up to 1 year
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Rebecca Sippel
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sippel RS, Robbins SE, Poehls JL, Pitt SC, Chen H, Leverson G, Long KL, Schneider DF, Connor NP. A Randomized Controlled Clinical Trial: No Clear Benefit to Prophylactic Central Neck Dissection in Patients With Clinically Node Negative Papillary Thyroid Cancer. Ann Surg. 2020 Sep 1;272(3):496-503. doi: 10.1097/SLA.0000000000004345.
citation: Kletzien H, Macdonald CL, Orne J, Francis DO, Leverson G, Wendt E, Sippel RS, Connor NP. Comparison Between Patient-Perceived Voice Changes and Quantitative Voice Measures in the First Postoperative Year After Thyroidectomy: A Secondary Analysis of a Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2018 Nov 1;144(11):995-1003. doi: 10.1001/jamaoto.2018.0309.