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Completed

NCT Number: NCT02138214

Central Neck Dissection in Patients With Clinical Node Negative Thyroid Cancer

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Thyroidectomy

Procedure

Undergo total thyroidectomy

entral lymph node dissection (CLND)

Procedure

Undergo total thyroidectomy with ipsilateral prophylactic CND

Quality-of-Life Assessment

Other

Voice evaluation, interviews, ancillary studies

Primary outcomes

  1. Percentage of Participants With Transient Hypoparathyroidism, as Defined by a Day 1 Serum Parathyroid Hormone (PTH) Level of < 10 pg/ml

    Time frame: Post-operative day 1

    Rate of transient hypoparathyroidism will be assessed in terms of percentage of participants with day 1 serum PTH level of < 10 pg/ml.

  2. Post-operative Serum Calcium (mg/dL) at Day 12

    Time frame: At day 12

    Post-operative serum calcium (mg/dL) at Day 12

  3. Total Calcium Consumption in First 2 Weeks

    Time frame: 2 weeks after surgery

    Total calcium consumption in first 2 weeks (total mg). Participants were given calcium symptom logs in which to record their calcium consumption between surgery and their first preoperative follow up appointment, approximately two week.

  4. Number of Participants With Hypocalcemia Symptoms in First 2 Weeks

    Time frame: 2 weeks

    Number of participants with hypocalcemia symptoms and symptom severity in first two weeks, as defined by presence of clinically significant symptoms of hypocalcemia.

    Clinically significant symptoms defined as 1 or more episodes of symptoms of hypocalcemia per day for multiple days, symptoms leading to calls to provider for assistance with managing and/or symptoms leading to escalation of dosage of prescribed medications to treat symptoms of hypocalcemia

  5. Hypocalcemia Symptom Severity Scale (Range of 1-5)

    Time frame: 2 weeks post surgery

    Mean number of occurrences of mild (severity 1 - 2) and severe (severity 3 - 5) hypocalcemia symptoms. Participants were asked to record hypocalcemia symptoms between surgery and first postoperative follow-up at approximately two weeks in their provided calcium symptom logs and rank severity on scale of 1 (mild) to 5 (severe).

  6. Percentage of Participants That Required Calcium and Calcitriol at Month 6

    Time frame: At Month 6

    Requirement for calcium and calcitriol at Month 6 (or, if laboratory values at visit reveal calcium < 8 mg/dL and PTH <15 pg/ml)

  7. Post-operative Serum PTH (pg/ml) at Month 6

    Time frame: At Month 6

  8. Post-operative Serum Calcium Level at Month 6

    Time frame: At Month 6

    Post-operative serum calcium (mg/dL) at Month 6

Secondary outcomes

  1. Rate of Transient and Permanent Hypocalcemia

    Time frame: Post-operative day 1 - Month 6

    The rate of transient and permanent hypocalcemia will be determined by assessing the following:

    I. Post-operative serum calcium (mg/dl) and PTH (pg/ml) at Day 12 and Month 6 II. Total calcium consumption in first 2 weeks (total gm) III. Hypocalcemia symptoms in first 2 weeks (average episodes/day) IV. Hypocalcemia symptom severity scale (range 1-5) V. Requirement for calcium and calcitriol at Month 6 (or, if laboratory values at visit reveal calcium < 8 mg/dL and PTH < 15 pg/ml

    Data will be analyzed using the methods described above.

  2. Rate of Voice and Swallowing Problems

    Time frame: Post operative day 1 - up to 1 year

    The rate of voice and swallowing problems will be determined by assessing the following:

    I. Phonation threshold pressure, in centimeters of water II. Dysphonia severity index (DSI) score (+5 to -5) III. Grade Roughness Breathiness Asthenia Strain (GRBAS) score (0-3) IV. Voice quality parameters as measured by Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V) (0-100 on visual analog scale) V. Vocal fold vibratory and movement parameters as measured by stroboscopy assessment (1-4) VI. Glottal function index score VII. Penetration-Aspiration score as measured by videofluoroscopic swallow study (0-8)

    Data will be analyzed using the methods described above.

  3. Degree to Which Quality of Life (QOL) is Compromised

    Time frame: Post-operative day 1 - up to 1 year

    The degree to which quality (QOL) is compromised will be determined by assessing the following:

    I. Short Form Health Survey (SF-12) Mental Composite Scale (MCS) score II. Short Form Health Survey (SF-12) Physical Composite Scale (PCS) score III. European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) Core-30 (C30) score IV. Thyroid Cancer Specific Quality of Life (ThyCA-QOL) score V. 10-item Eating Assessment Tool (EAT-10) dysphagia inventory score VI. Voice Handicap Index (VHI) score VII. Themes and codes from interview transcripts assessed using qualitative research methods

    Data will be analyzed using the methods described above.

  4. Clinical Recurrence Rates

    Time frame: Week 6 - up to 5 years

    Clinical recurrence rates will be determined by assessing the following:

    I. Percent of patients with a recombinant thyroid-stimulating hormone (rTSH) stimulated thyroglobulin level < 1 ng/ml one year after surgery II. Unstimulated thyroglobulin level prior to beginning week 6 radioactive iodine treatment III. Stimulated thyroglobulin at the time of week 6 radioactive iodine treatment IV. Incidence of unstimulated thyroglobulin > 1 ng/mL at 6 months V. Incidence of stimulated thyroglobulin > 2 ng/mL at 1 year VI. Incidence of biopsy-proven disease identification on neck ultrasound or iodine-131 (I-131) uptake up to 5 years post-surgery

    Data will be analyzed using the methods described above.

  5. Degree to Which Accurate Quality of Life (QOL) Measures Can be Extracted From Patient Interview Narratives Using Natural Language Processing Techniques

    Time frame: Post-operative day 1 - up to 1 year

    The degree to which accurate quality of life (QOL) measures can be extracted from patient interview narratives using natural language process techniques will allow for the development of computer algorithms that convert patient narrative text into simple quality of life measures. Data will be analyzed using the methods described above.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Thyroid Gland Removal With or Without Central Lymph Node Dissection in Treating Patients With Node Negative Thyroid Cancer

Important dates

Study start
2014
Primary completion
2019
Study completion
2020
First posted
May 14, 2014
Registry last updated
Dec 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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