Total Thyroidectomy With and Without Prophylactic Central Neck Lymph Node Dissection in People With Low-risk Papillary Thyroid Cancer

NCT02408887 | Terminated Phase 2 Results DMC

• 2 other identifiers: 15010515-C-0105
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

Background: \- Papillary thyroid cancer (PTC) often spreads to lymph nodes in the neck. This can be hard to detect. People often have lymph nodes removed anyway, and researchers want to study if this is a good idea. Objective: \- To compare the effectiveness of removing lymph nodes in the neck that show no evidence of cancer along with the thyroid, or removing only the thyroid. Eligibility: \- Adults age 18 and older with PTC or thyroid nodules suspicious for PTC, with no evidence that the disease has spread in the body. Design:

• Participants will be screened with medical history, physical exam, blood tests, scans, and x-rays.
• Participants will:
• Answer questions. They may have a tumor biopsy.
• Have a flexible laryngoscopy. A small tube will pass through the nose to the vocal cords.
• Group 1: have surgery to remove the thyroid gland only. Lymph nodes in the neck will be removed if the cancer has spread.
• Group 2: have surgery to remove the thyroid and lymph nodes in the neck.
• At all post-surgery visits, participants will answer questions and have blood drawn. In addition:
• 1 day: laryngoscopy.
• 2 weeks: possible laryngoscopy.
• 3 months: ultrasound of the thyroid and neck.
• Discuss whether to try hormone treatment and/or radioactive iodine.
• Possible diagnostic whole body radioiodine scan (WBS). Participants will swallow a capsule or liquid and lie under a camera.
• 6 months: ultrasound and maybe laryngoscopy.
• 1 year: diagnostic WBS and ultrasound. Participants may get thyroid stimulating hormone.
• Participants will have annual follow-up visits for 10 years. They will have a physical exam, blood drawn, scans, and may complete a questionnaire.

Conditions

Low-risk Papillary Thyroid Cancer; Endocrine Malignancy; Thyroid Cancer

Keywords

Thyroidectomy; Serum Thyroglobulin; Quality of Life; Central Neck Lymph Node Metastasis; Central Neck Lymph Node Dissection

Outcome Measures

Primary Outcomes (1)

• Number of Participants That Have Biochemical Cure After Total Thyroidectomy (TT) With and Without Prophylactic Central Neck Lymph Node Dissection (pCND)

  number of participants that have biochemical cure after total thyroidectomy (TT) with and without pCND as measured by postoperative thyroid stimulating hormone (TSH)-stimulated serum thyroglobulin (stim-Tg). Per protocol, Biochemical cure is defined as "stim-Tg \< 2 ng/ml or unstimulated Tg ≤ 0.2 ng/ml" post-surgery. Biochemical persistent or recurrent disease is suspected when stim-Tg ≥5 ng/ml or unstimulated Tg \>0.3 ng/ml or a conversion or a rise in anti-Tg antibodies.

  At 3 months (prior to radioactive iodine (RAI) treatment)

Secondary Outcomes (9)

• Number of Participants That Have Biochemical Cure After Total Thyroidectomy (TT) With and Without Prophylactic Central Neck Lymph Node Dissection (pCND)

  Up to 1 year postoperatively or 1 year post remnant ablation.

• Number of Participants Who Completed Quality of Life (QOL) Survey at Following Timepoints: Quality of Life After Total Thyroidectomy (TT) With and Without Prophylactic Central Neck Lymph Node Dissection (pCND)

  pre-operation(op), post-op day 1 and 2, 2 and 3 weeks post-op, 3, 6 and 9 months post-op, 1 and 2 years post-op. Approximately 4 years.

• Voice Quality After Total Thyroidectomy (TT) With and Without Prophylactic Central Neck Lymph Node Dissection (pCND) at 6 Months

  baseline - pre-op and 6 months post-op

• Number of Participants With Hypoparathyroidism

  6 months

• Number of Participants That Have Cervical Wound Complications

  3 months

Other Outcomes (1)

• Number of Participants With Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0)

  Date treatment consent signed to date off study, approximately 46 months and 23 days for the first group and 48 months and 3 days for the second group.

Study Arms (2)

Arm 2/Total Thyroidectomy (TT) Plus Prophylactic Central Neck Dissection (pCND)

ACTIVE COMPARATOR

TT plus pCND

Procedure: Total Thyroidectomy (TT); Procedure: Prophylactic central neck lymph node dissection (pCND)

Arm 1/Total Thyroidectomy (TT) alone

ACTIVE COMPARATOR

TT alone

Procedure: Total Thyroidectomy (TT)

Interventions

Total Thyroidectomy (TT) PROCEDURE

Total removal of thyroid

Arm 1/Total Thyroidectomy (TT) alone; Arm 2/Total Thyroidectomy (TT) Plus Prophylactic Central Neck Dissection (pCND)

Prophylactic central neck lymph node dissection (pCND) PROCEDURE

Lymph node dissection

Arm 2/Total Thyroidectomy (TT) Plus Prophylactic Central Neck Dissection (pCND)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have histologically or cytologically confirmed at least 1 thyroid nodule that is greater than or equal to1 cm. but less than or equal to 4 cm measured in greatest dimension and confirmed by the Laboratory of Pathology, National Cancer Institute (NCI) or confirmed by the pathology laboratory of the enrolling institution:
• Indeterminate thyroid biopsy per Bethesda System for reporting thyroid cytopathology with B-Raf Proto-oncogene Serine/Threonine Kinase (BRAF) Valine 600 Glutamic Acid (V600E) mutation or rearranged in transformation/papillary thyroid carcinomas (RET/PTC) rearrangement
• Cytologically or histologically suspicious or confirmed PTC per Bethesda System for reporting thyroid cytopathology.
• Age greater than or equal to 18 years. Because PTC occurs rarely in patients \<18 years of age, children are excluded from this study.
• Absence of radiographic evidence of extrathyroidal extension.
• Absence of abnormal lymphadenopathy suggesting metastatic PTC on physical examination and/or imaging studies.
• Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
• Patients must have adequate organ function to safely undergo general anesthesia and thyroidectomy. Laboratory values obtained less than or equal to 4 weeks prior to surgery must demonstrate adequate bone marrow function (hemoglobin (Hb) greater than or equal to 6.0 mmol/L, absolute neutrophil count greater than or equal to 1.5 x 10\^9/L, platelets greater than or equal to 80 x 10\^9/L), liver function (serum bilirubin less than or equal to 2 x upper limit of normal (ULN), serum transaminases less than or equal to 3 x ULN). Patients with chronic kidney disease who are on chronic renal replacement therapy are allowed. Other tests, such as pulmonary function tests, cardiac echocardiogram or stress test, will be performed if clinically indicated.
• Ability of subject to understand and the willingness to sign a written informed consent document.
• Women must not become pregnant prior to surgery or during the first 3 months after surgery. Women who can become pregnant will be asked to practice an effective form of birth control for up to 3 months after surgery.

You may not qualify if:

• Patients who have had previous thyroid surgery
• Patients whose tumors are deemed unresectable by clinical/imaging criteria.
• Patients with known synchronous distant metastatic disease.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Pregnant women are excluded because we do not want to expose the unborn child to the procedures necessary to perform the surgery.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Lang BH, Wong KP, Wan KY, Lo CY. Significance of metastatic lymph node ratio on stimulated thyroglobulin levels in papillary thyroid carcinoma after prophylactic unilateral central neck dissection. Ann Surg Oncol. 2012 Apr;19(4):1257-63. doi: 10.1245/s10434-011-2105-5. Epub 2011 Oct 12.

  PMID: 21989667 BACKGROUND

• Iyer NG, Morris LG, Tuttle RM, Shaha AR, Ganly I. Rising incidence of second cancers in patients with low-risk (T1N0) thyroid cancer who receive radioactive iodine therapy. Cancer. 2011 Oct 1;117(19):4439-46. doi: 10.1002/cncr.26070. Epub 2011 Mar 22.

  PMID: 21432843 BACKGROUND

• Lee J, Kwon IS, Bae EH, Chung WY. Comparative analysis of oncological outcomes and quality of life after robotic versus conventional open thyroidectomy with modified radical neck dissection in patients with papillary thyroid carcinoma and lateral neck node metastases. J Clin Endocrinol Metab. 2013 Jul;98(7):2701-8. doi: 10.1210/jc.2013-1583. Epub 2013 May 15.

  PMID: 23678034 BACKGROUND

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Thyroid Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Results Point of Contact

• Title: Dr. Naris Nilubol
• Organization: National Cancer Institute

niluboln@mail.nih.gov

240-760-6154

Study Officials

• Naris Nilubol, M.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 3, 2015
• First Posted: April 6, 2015
• Study Start: April 15, 2015
• Primary Completion: March 26, 2019
• Study Completion: May 7, 2019
• Last Updated: September 27, 2022
• Results First Posted: September 27, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Before publication. At the time of publication or shortly thereafter.
• Access Criteria: A National Institutes of Health (NIH)-funded or approved public repository, clinicaltrials.gov. Biomedical Translational Research Information System (BTRIS) (automatic for activities in the Clinical Center). Publication and/or public presentations.

Locations

US (1)