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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 : Recruiting
First Posted : May 14, 2014
Last Update Posted : August 7, 2019
Sponsor:
Collaborators:
National Cancer Institute (NCI)
National Institutes of Health (NIH)
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: Central lymph node dissection 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)
Estimated Enrollment : 140 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
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : December 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: Central lymph node dissection
Undergo total thyroidectomy with ipsilateral prophylactic CND
Other Name: CLND

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. Rate of transient hypoparathyroidism, as defined by a day 1 serum parathyroid hormone (PTH) level of < 10 pg/ml [ Time Frame: Post-operative day 1 ]
    Data will be analyzed using a mixed model 2-way analysis of variance (ANOVA) examining the effects of treatment group, time and factor interactions, such as radioactive iodine dose. Evaluation time periods (pre-surgery, week 2, week 6, month 6, and 1 year) will serve as between subjects factor and treatment group (prophylactic CND vs no CND) will serve as the between subjects factor. Experiment-wise error will be controlled with an appropriate adjustment to the alpha-level. Data will be transformed as necessary. Nonparametric statistics will be used when assumptions for ANOVA are not achieved.


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.



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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


Contacts
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Contact: Cancer Connect (800) 622-8922 cancerconnect@uwcarbone.wisc.edu

Locations
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United States, Wisconsin
University of Wisconsin Recruiting
Madison, Wisconsin, United States, 53792
Contact: Rebecca S. Sippel       sippel@surgery.wisc.edu   
Principal Investigator: Rebecca S. Sippel         
Sponsors and Collaborators
University of Wisconsin, Madison
National Cancer Institute (NCI)
National Institutes of Health (NIH)
Investigators
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Principal Investigator: Rebecca Sippel 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     History of Changes
Other Study ID Numbers: UW13115
NCI-2014-00833 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
UW13115 ( Other Identifier: University of Wisconsin Hospital and Clinics )
R01CA176911 ( U.S. NIH Grant/Contract )
P30CA014520 ( U.S. NIH Grant/Contract )
2014-0391 ( Other Identifier: UW-Madison Health Sciences IRB )
First Posted: May 14, 2014    Key Record Dates
Last Update Posted: August 7, 2019
Last Verified: August 2019
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