Central Neck Dissection in Patients With Clinical Node Negative Thyroid Cancer

Stage II Papillary Thyroid Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02138214
• Other study ID #: UW13115
• Secondary ID: NCI-2014-00833UW
• Status: Completed
• Phase: Phase 2
• Start date: June 6, 2014
• Est. completion date: October 26, 2020

Study information

• Verified date: February 2020
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 117
• Est. completion date: October 26, 2020
• Est. primary completion date: October 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 73 Years

Eligibility

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

Related Conditions & MeSH terms

• Stage I Papillary Thyroid Cancer
• Stage II Papillary Thyroid Cancer
• Stage III Papillary Thyroid Cancer
• Thyroid Cancer, Papillary
• Thyroid Diseases
• Thyroid Neoplasms

Intervention

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

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

Locations

Country	Name	City	State
United States	University of Wisconsin	Madison	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Transient Hypoparathyroidism, as Defined by a Day 1 Serum Parathyroid Hormone (PTH) Level of < 10 pg/ml	Rate of transient hypoparathyroidism will be assessed in terms of percentage of participants with day 1 serum PTH level of < 10 pg/ml.	Post-operative day 1
Primary	Post-operative Serum Calcium (mg/dL) at Day 12	Post-operative serum calcium (mg/dL) at Day 12	At day 12
Primary	Total Calcium Consumption in First 2 Weeks	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.	2 weeks after surgery
Primary	Number of Participants With Hypocalcemia Symptoms in First 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	2 weeks
Primary	Hypocalcemia Symptom Severity Scale (Range of 1-5)	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).	2 weeks post surgery
Primary	Percentage of Participants That Required Calcium and Calcitriol 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)	At Month 6
Primary	Post-operative Serum PTH (pg/ml) at Month 6		At Month 6
Primary	Post-operative Serum Calcium Level at Month 6	Post-operative serum calcium (mg/dL) at Month 6	At Month 6
Secondary	Rate of Transient and Permanent Hypocalcemia	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.	Post-operative day 1 - Month 6
Secondary	Rate of Voice and Swallowing Problems	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.	Post operative day 1 - up to 1 year
Secondary	Degree to Which Quality of Life (QOL) is Compromised	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.	Post-operative day 1 - up to 1 year
Secondary	Clinical Recurrence Rates	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.	Week 6 - up to 5 years
Secondary	Degree to Which Accurate Quality of Life (QOL) Measures Can be Extracted From Patient Interview Narratives Using Natural Language Processing Techniques	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.	Post-operative day 1 - up to 1 year

External Links

•   University of Wisconsin Carbone Cancer Center Homepage