Trial Outcomes & Findings for Total Thyroidectomy With and Without Prophylactic Central Neck Lymph Node Dissection in People With Low-risk Papillary Thyroid Cancer (NCT NCT02408887)

Last Updated: 2022-09-27

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

14 participants

Primary outcome timeframe

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

Results posted on

2022-09-27

Participant Flow

Participant milestones

Participant milestones
Measure	Arm 2/Total Thyroidectomy (TT) Plus Prophylactic Central Neck Dissection (pCND) pCND plus TT Total Thyroidectomy (TT): Total removal of thyroid Prophylactic central neck lymph node dissection (pCND): Lymph node dissection	Arm 1/Total Thyroidectomy (TT) Alone TT alone Total Thyroidectomy (TT): Total removal of thyroid
Overall Study STARTED	8	6
Overall Study COMPLETED	7	5
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm 2/Total Thyroidectomy (TT) Plus Prophylactic Central Neck Dissection (pCND) pCND plus TT Total Thyroidectomy (TT): Total removal of thyroid Prophylactic central neck lymph node dissection (pCND): Lymph node dissection	Arm 1/Total Thyroidectomy (TT) Alone TT alone Total Thyroidectomy (TT): Total removal of thyroid
Overall Study Participant was inevaluable due to advanced cancer	1	0
Overall Study Participant was inevaluable due to benign pathology.	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm 2/Total Thyroidectomy (TT) Plus Prophylactic Central Neck Dissection (pCND) n=8 Participants pCND plus TT Total Thyroidectomy (TT): Total removal of thyroid Prophylactic central neck lymph node dissection (pCND): Lymph node dissection	Arm 1/Total Thyroidectomy (TT) Alone n=6 Participants TT alone Total Thyroidectomy (TT): Total removal of thyroid	Total n=14 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants	5 Participants n=7 Participants	13 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Age, Continuous	43.50 years STANDARD_DEVIATION 14.35 • n=5 Participants	56.17 years STANDARD_DEVIATION 14.16 • n=7 Participants	48.93 years STANDARD_DEVIATION 15.18 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Black	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized White	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized Non-Hispanic	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Race/Ethnicity, Customized Unknown	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Other	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants	6 participants n=7 Participants	14 participants n=5 Participants

PRIMARY outcome

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

Population: One participant in Arm 2, and two participants in Arm 1 was inevaluable.

Outcome measures

Outcome measures
Measure	Arm 2/Total Thyroidectomy (TT) Plus Prophylactic Central Neck Dissection (pCND) n=7 Participants pCND plus TT Total Thyroidectomy (TT): Total removal of thyroid Prophylactic central neck lymph node dissection (pCND): Lymph node dissection	Arm 1/Total Thyroidectomy (TT) Alone n=4 Participants TT alone Total Thyroidectomy (TT): Total removal of thyroid
Number of Participants That Have Biochemical Cure After Total Thyroidectomy (TT) With and Without Prophylactic Central Neck Lymph Node Dissection (pCND) Biochemical cure	7 Participants	3 Participants
Number of Participants That Have Biochemical Cure After Total Thyroidectomy (TT) With and Without Prophylactic Central Neck Lymph Node Dissection (pCND) Biochemical persistent or recurrent disease	0 Participants	1 Participants

SECONDARY outcome

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

Population: One participant in Arm 2, and two participants in Arm 1 was inevaluable.

Participants that have biochemical cure after TT with and without pCND by postoperative thyroid-stimulating hormone (TSH)-stimulated serum thyroglobulin (stim-Tg) at 1 year postoperatively in participants who will not receive radioactive iodine (RAI) or 1 year post remnant ablation. 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.

Outcome measures

Outcome measures
Measure	Arm 2/Total Thyroidectomy (TT) Plus Prophylactic Central Neck Dissection (pCND) n=7 Participants pCND plus TT Total Thyroidectomy (TT): Total removal of thyroid Prophylactic central neck lymph node dissection (pCND): Lymph node dissection	Arm 1/Total Thyroidectomy (TT) Alone n=4 Participants TT alone Total Thyroidectomy (TT): Total removal of thyroid
Number of Participants That Have Biochemical Cure After Total Thyroidectomy (TT) With and Without Prophylactic Central Neck Lymph Node Dissection (pCND) Biochemical cure	6 Participants	4 Participants
Number of Participants That Have Biochemical Cure After Total Thyroidectomy (TT) With and Without Prophylactic Central Neck Lymph Node Dissection (pCND) Biochemical persistent or recurrent disease	0 Participants	0 Participants
Number of Participants That Have Biochemical Cure After Total Thyroidectomy (TT) With and Without Prophylactic Central Neck Lymph Node Dissection (pCND) Inconclusive evidence of biochemical cure	1 Participants	0 Participants

SECONDARY outcome

Timeframe: 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.

Population: Not all participants in the respective Arms had completed SF-36 surveys in the timepoints stated in the protocol. The SF-36 survey responses were not scored prior to closure of study.

Number of participants that completed the Quality-of-Life SF-36 questionnaire after TT with and without pCND.

Outcome measures

Outcome measures
Measure	Arm 2/Total Thyroidectomy (TT) Plus Prophylactic Central Neck Dissection (pCND) n=7 Participants pCND plus TT Total Thyroidectomy (TT): Total removal of thyroid Prophylactic central neck lymph node dissection (pCND): Lymph node dissection	Arm 1/Total Thyroidectomy (TT) Alone n=5 Participants TT alone Total Thyroidectomy (TT): Total removal of thyroid
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-op	7 Participants	5 Participants
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) Post-op day 1	6 Participants	3 Participants
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) Post-op day 2	0 Participants	1 Participants
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) 2 weeks post-op	5 Participants	3 Participants
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) 3 weeks post-op	1 Participants	1 Participants
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) 3 months post-op	7 Participants	5 Participants
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) 6 months post-op	6 Participants	4 Participants
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) 9 months post-op	1 Participants	0 Participants
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) 1 year post-op	5 Participants	4 Participants
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) 2 years post-op	0 Participants	1 Participants

SECONDARY outcome

Timeframe: baseline - pre-op and 6 months post-op

Population: One participant in Arm 2, and Arm 1 was inevaluable.

Participants that have improvement in voice quality after TT with and without pCND assessed by the Voice Handicap Index-10 questionnaire. The Voice Handicap Index-10 (VHI-10) is a self-administered questionnaire that assesses participant's subjective voice quality. The average voice scores/indices at 6 months post-operation was measured for all participants per group. Minimum score is 0 and maximum score is 40.The higher the score the worse voice quality.

Outcome measures

Outcome measures
Measure	Arm 2/Total Thyroidectomy (TT) Plus Prophylactic Central Neck Dissection (pCND) n=7 Participants pCND plus TT Total Thyroidectomy (TT): Total removal of thyroid Prophylactic central neck lymph node dissection (pCND): Lymph node dissection	Arm 1/Total Thyroidectomy (TT) Alone n=5 Participants TT alone Total Thyroidectomy (TT): Total removal of thyroid
Voice Quality After Total Thyroidectomy (TT) With and Without Prophylactic Central Neck Lymph Node Dissection (pCND) at 6 Months Baseline- Pre-op	3 score on a scale Interval 0.0 to 13.0	0 score on a scale Interval 0.0 to 20.0
Voice Quality After Total Thyroidectomy (TT) With and Without Prophylactic Central Neck Lymph Node Dissection (pCND) at 6 Months 6 months Post-op	3 score on a scale Interval 0.0 to 27.0	6 score on a scale Interval 0.0 to 25.0

SECONDARY outcome

Timeframe: 6 months

Population: One participant in Arm 2, and Arm 1 was inevaluable.

Number of participants with hypoparathyroidism 6 months post total thyroidectomy with and without prophylactic central neck lymph node dissection. Hypoparathyroidism occurs when one or more of your parathyroid glands are underactive and can lead to low parathyroid hormone and hypocalcemia.

Outcome measures

Outcome measures
Measure	Arm 2/Total Thyroidectomy (TT) Plus Prophylactic Central Neck Dissection (pCND) n=7 Participants pCND plus TT Total Thyroidectomy (TT): Total removal of thyroid Prophylactic central neck lymph node dissection (pCND): Lymph node dissection	Arm 1/Total Thyroidectomy (TT) Alone n=5 Participants TT alone Total Thyroidectomy (TT): Total removal of thyroid
Number of Participants With Hypoparathyroidism	2 Participants	5 Participants

SECONDARY outcome

Timeframe: 3 months

Population: One participant in Arm 2, and Arm 1 was inevaluable.

number of participants that have cervical wound complications such as a hematoma, seroma, and/or surgical site infection.

Outcome measures

Outcome measures
Measure	Arm 2/Total Thyroidectomy (TT) Plus Prophylactic Central Neck Dissection (pCND) n=7 Participants pCND plus TT Total Thyroidectomy (TT): Total removal of thyroid Prophylactic central neck lymph node dissection (pCND): Lymph node dissection	Arm 1/Total Thyroidectomy (TT) Alone n=5 Participants TT alone Total Thyroidectomy (TT): Total removal of thyroid
Number of Participants That Have Cervical Wound Complications Hematoma	0 Participants	0 Participants
Number of Participants That Have Cervical Wound Complications Seroma	0 Participants	0 Participants
Number of Participants That Have Cervical Wound Complications Surgical site infection	0 Participants	0 Participants

SECONDARY outcome

Timeframe: At progression

Population: This outcome measure was not done because data were not collected.

Correlation between BRAF V600E of tumor

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Population: This outcome measure was not done because data were not collected.

Proportion of participants that have less neck pain assessed by the Neck Pain Scale (0 = no pain, and 10 = unimaginable, unspeakable pain).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline - pre-op and 6 months post-op

Population: One participant in Arm 2, and Arm 1 was inevaluable.

Participants that have improvement in swallowing impairment after Total Thyroidectomy (TT) with and without Prophylactic Central Neck Lymph Node Dissection (pCND) assessed by the Swallowing Impairment Score (SIS-6) questionnaire. The average swallowing scores/indices at 6 months post-operation was measured for all participants per group. Minimum score is 0 and maximum score is 24. The higher the score indicates worse swallowing symptoms.

Outcome measures

Outcome measures
Measure	Arm 2/Total Thyroidectomy (TT) Plus Prophylactic Central Neck Dissection (pCND) n=7 Participants pCND plus TT Total Thyroidectomy (TT): Total removal of thyroid Prophylactic central neck lymph node dissection (pCND): Lymph node dissection	Arm 1/Total Thyroidectomy (TT) Alone n=5 Participants TT alone Total Thyroidectomy (TT): Total removal of thyroid
Improvement in Swallowing Impairment After Total Thyroidectomy (TT) With and Without Prophylactic Central Neck Lymph Node Dissection (pCND) at 6 Months Baseline - Pre-op	0 score on a scale Interval 0.0 to 15.0	3 score on a scale Interval 0.0 to 6.0
Improvement in Swallowing Impairment After Total Thyroidectomy (TT) With and Without Prophylactic Central Neck Lymph Node Dissection (pCND) at 6 Months 6 months Post-op	4 score on a scale Interval 0.0 to 19.0	5 score on a scale Interval 0.0 to 18.0

SECONDARY outcome

Timeframe: Completed at pre-operation (op), 3 months, 6 months, 1 year, 2 years and 3 years post-op.

Population: One participant in Arm 2, and two participants in Arm 1 was inevaluable. And not all participants in Arm 2 and Arm 1 had an ultrasound of the neck at each timepoint.

Disease progression is defined as a clinically detectable evidence of disease recurrence after surgery. Disease recurrence is the progression since participants were deemed to have no evidence of disease after surgery. Post-op ultrasounds were assessed for findings that are indicative/suspicious of disease recurrence. No specific response criteria (i.e. RECIST) was used. Ultrasound of neck soft tissue findings indicate progression/recurrence.

Outcome measures

Outcome measures
Measure	Arm 2/Total Thyroidectomy (TT) Plus Prophylactic Central Neck Dissection (pCND) n=7 Participants pCND plus TT Total Thyroidectomy (TT): Total removal of thyroid Prophylactic central neck lymph node dissection (pCND): Lymph node dissection	Arm 1/Total Thyroidectomy (TT) Alone n=5 Participants TT alone Total Thyroidectomy (TT): Total removal of thyroid
Number of Participants Who Developed Disease Progression or Recurrence After Surgery 6 months	0 Participants	0 Participants
Number of Participants Who Developed Disease Progression or Recurrence After Surgery 1 year	0 Participants	0 Participants
Number of Participants Who Developed Disease Progression or Recurrence After Surgery 2 years	0 Participants	0 Participants
Number of Participants Who Developed Disease Progression or Recurrence After Surgery 3 years	0 Participants	0 Participants
Number of Participants Who Developed Disease Progression or Recurrence After Surgery Pre-op	0 Participants	0 Participants
Number of Participants Who Developed Disease Progression or Recurrence After Surgery 3 months	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Here is the number of participants with non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence.

Outcome measures

Outcome measures
Measure	Arm 2/Total Thyroidectomy (TT) Plus Prophylactic Central Neck Dissection (pCND) n=8 Participants pCND plus TT Total Thyroidectomy (TT): Total removal of thyroid Prophylactic central neck lymph node dissection (pCND): Lymph node dissection	Arm 1/Total Thyroidectomy (TT) Alone n=6 Participants TT alone Total Thyroidectomy (TT): Total removal of thyroid
Number of Participants With Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0)	1 Participants	0 Participants

Adverse Events

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

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Arm 1/Total Thyroidectomy (TT) Alone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Arm 2/Total Thyroidectomy (TT) Plus Prophylactic Central Neck Dissection (pCND) n=8 participants at risk pCND plus TT Total Thyroidectomy (TT): Total removal of thyroid Prophylactic central neck lymph node dissection (pCND): Lymph node dissection	Arm 1/Total Thyroidectomy (TT) Alone n=6 participants at risk TT alone Total Thyroidectomy (TT): Total removal of thyroid
Blood and lymphatic system disorders Anemia	12.5% 1/8 • Number of events 1 • 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.	0.00% 0/6 • 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.
Nervous system disorders Lethargy	12.5% 1/8 • Number of events 1 • 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.	0.00% 0/6 • 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.
Vascular disorders Hypotension	12.5% 1/8 • Number of events 1 • 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.	0.00% 0/6 • 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.

Additional Information

Dr. Naris Nilubol

National Cancer Institute

Phone: 240-760-6154

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place