Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02408887
Recruitment Status : Completed
First Posted : April 6, 2015
Last Update Posted : October 9, 2019
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

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.

Condition or disease Intervention/treatment Phase
Low-risk Papillary Thyroid Cancer Endocrine Malignancy Thyroid Cancer Procedure: Total Thyroidectomy (TT) Procedure: Prophylactic central neck lymph node dissection(pCND) Phase 2

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Total Thyroidectomy With and Without Prophylactic Central Neck Lymph Node Dissection in Patients With Low-risk Papillary Thyroid Cancer
Study Start Date : April 3, 2015
Actual Primary Completion Date : May 7, 2019
Actual Study Completion Date : May 7, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Thyroid

Arm Intervention/treatment
Active Comparator: 1
pCND plus TT
Procedure: Total Thyroidectomy (TT)
Total removal of thyroid

Procedure: Prophylactic central neck lymph node dissection(pCND)
Lymph node dissection

Active Comparator: 2
TT alone
Procedure: Total Thyroidectomy (TT)
Total removal of thyroid




Primary Outcome Measures :
  1. Biochemical cure rates undergoing total thyroidectomy (TT) with and without pCND as measured by postoperative TSH-stimulated serum thyroglobulin (stim-Tg) at 3 months (prior to RAI treatment) [ Time Frame: 3 months ]
    Proportion of patients that have biochemical cure after totalthyroidectomy (TT) with and without pCND


Secondary Outcome Measures :
  1. Biochemical cure rates in patients undergoing total thyroidectomy with and without pCND by postoperative TSH-stimulated serum thyroglobulin (stim-Tg) at 1 year postoperatively in patients who will not receive RAI or 1 year post remnant ablation [ Time Frame: 1 year ]
    Proportion of patients that have biochemical cure after TT with andwithout pCND

  2. The QOL of patients [ Time Frame: 10 years ]
    Proportion of patients that have improvement in quality of life afterTT with and without pCND

  3. Subjective voice quality, swallowing impairment [ Time Frame: 6 month ]
    Proportion of patients that have improvement in voice quality,swallowing impairment after TT with and without pCND

  4. Rate and duration of both symptomatic and asymptomatic hypoparathyroidism [ Time Frame: 6 month ]
    Rate and duration hypoparathyroidism

  5. Rate of cervical wound complications [ Time Frame: 3 month ]
    Proportion of patients that have cervical wound complications

  6. Correlation between BRAF V600E of tumor and median amount of time before disease progression [ Time Frame: at progression ]
    Correlation between BRAF V600E of tumor and median amount of time before disease progression

  7. Neck pain [ Time Frame: 6 month ]
    Proportion of patients that have less neck pain



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:
  • 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, NCI or confirmed by the pathology laboratory of the enrolling institution:

    • Indeterminate thyroid biopsy per Bethesda System for reporting thyroid cytopathology with BRAF V600E mutation or 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.
  • 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 (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 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.

EXCLUSION CRITERIA:

  • 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.

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): NCT02408887


Locations
Layout table for location information
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Layout table for investigator information
Principal Investigator: Naris Nilubol, M.D. National Cancer Institute (NCI)

Additional Information:
Publications:
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT02408887     History of Changes
Other Study ID Numbers: 150105
15-C-0105
First Posted: April 6, 2015    Key Record Dates
Last Update Posted: October 9, 2019
Last Verified: July 30, 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):
Thyroidectomy
Serum Thyroglobulin
Quality of Life
Central Neck Lymph Node Metastasis
Central Neck Lymph Node Dissection
Additional relevant MeSH terms:
Layout table for MeSH terms
Thyroid Neoplasms
Thyroid Cancer, Papillary
Thyroid Diseases
Neoplasms
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Adenocarcinoma, Papillary
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type