NCT02408887|TerminatedPhase 2ResultsDMC

Study Stopped

Slow/Insufficient accrual

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

Randomized Controlled Trial of Total Thyroidectomy With and Without Prophylactic Central Neck Lymph Node Dissection in Patients With Low-risk Papillary Thyroid Cancer

National Cancer Institute (NCI)ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

150105

Secondary identifiers

15-C-0105

Study Type

interventional

Actual enrollment (reported)

Locations

1 country

Sites

Timeline

Study Start

April 15, 2015

Actual (reported)

Primary Completion

March 26, 2019

Actual (reported)

Study Completion

May 7, 2019

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: terminated
Actual enrollment (reported): 14 participants
Study completion date: May 7, 2019
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

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Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
April 3, 2015
Actual (reported)
First Posted
April 6, 2015
Actual (reported)
Study Start
April 15, 2015
Actual (reported)
Primary Completion
March 26, 2019
Actual (reported)
Study Completion
May 7, 2019
Actual (reported)
Results Posted
September 27, 2022
Actual (reported)

Last Updated: September 27, 2022
Status Verified: September 2022
Results QC Date: September 8, 2022
Last Update Submitted: September 8, 2022

Conditions

Endocrine Malignancy Low-risk Papillary Thyroid Cancer Thyroid Cancer

Keywords

ThyroidectomySerum ThyroglobulinQuality of LifeCentral Neck Lymph Node Metastasis

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (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.

Contact the study team to confirm eligibility.

Data Sharing

IPD Sharing

Will share

Coded, linked data in a National Institutes of Health (NIH)-funded or approved public repository. Coded, linked data in Biomedical Translational Research Information System (BTRIS) (automatic for activities in the Clinical Center). Identified or coded, linked data with approved participating sites under appropriate agreements.

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.

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier

NCT02408887

Data provider

ClinicalTrials.gov

Source updated

2022-09-27

Normalization version

ctgov-legacy-1

Source retrieved: 2026-10-25 22:36:51 UTC

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (9)

Other Outcomes (1)

Study Arms (2)

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

Arm 1/Total Thyroidectomy (TT) alone

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (3)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

Data Sharing

Source record

Documents

Locations