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Central Neck Dissection in Patients With Clinical Node Negative Thyroid Cancer

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ClinicalTrials.gov Identifier: NCT02138214
Recruitment Status : Completed
First Posted : May 14, 2014
Results First Posted : December 21, 2020
Last Update Posted : December 21, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Wisconsin, Madison

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.

Condition or disease Intervention/treatment Phase
Stage I Papillary Thyroid Cancer Stage II Papillary Thyroid Cancer Stage III Papillary Thyroid Cancer Procedure: Thyroidectomy Procedure: entral lymph node dissection (CLND) Other: Quality-of-life assessment Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 117 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Thyroid Gland Removal With or Without Central Lymph Node Dissection in Treating Patients With Node Negative Thyroid Cancer
Actual Study Start Date : June 6, 2014
Actual Primary Completion Date : October 30, 2019
Actual Study Completion Date : October 26, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm I (no CND)
Patients undergo total thyroidectomy alone.
Procedure: Thyroidectomy
Undergo total thyroidectomy

Other: Quality-of-life assessment
Voice evaluation, interviews, ancillary studies

Experimental: Arm II (CND)
Patients undergo total thyroidectomy with ipsilateral prophylactic CND.
Procedure: Thyroidectomy
Undergo total thyroidectomy

Procedure: entral lymph node dissection (CLND)
Undergo total thyroidectomy with ipsilateral prophylactic CND

Other: Quality-of-life assessment
Voice evaluation, interviews, ancillary studies

Active Comparator: Arm III (SOC)
Patients who are not eligible for randomization into Arm I or Arm II, Standard of Care (SOC) group. No specific trial intervention, treated as per patient and physician preference
Other: Quality-of-life assessment
Voice evaluation, interviews, ancillary studies




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 73 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02138214


Locations
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United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Rebecca Sippel University of Wisconsin, Madison
  Study Documents (Full-Text)

Documents provided by University of Wisconsin, Madison:
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT02138214    
Other Study ID Numbers: UW13115
NCI-2014-00833 ( Registry Identifier: NCI Trial ID )
UW13115 ( Other Identifier: University of Wisconsin Carbone Cancer Center )
R01CA176911 ( U.S. NIH Grant/Contract )
2014-0391 ( Other Identifier: UW-Madison Health Sciences IRB )
A539700 ( Other Identifier: UW Madison )
SMPH\SURGERY\SURGERY ( Other Identifier: UW Madison )
First Posted: May 14, 2014    Key Record Dates
Results First Posted: December 21, 2020
Last Update Posted: December 21, 2020
Last Verified: February 2020
Additional relevant MeSH terms:
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Thyroid Neoplasms
Thyroid Cancer, Papillary
Thyroid Diseases
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Adenocarcinoma, Papillary
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type