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Thyroxine Replacement Therapy After Lobectomy for Low-risk Papillary Thyroid Carcinoma

Primary Purpose

Thyroid Cancer, Surgery, Recurrence

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Thyroxine
Sponsored by
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thyroid Cancer focused on measuring thyroid cancer, lobectomy, TSH replacement, recurrence

Eligibility Criteria

18 Months - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: (1) Age 18-70 years old, ECOG score 0-2; (2) Patients with the maximum diameter of unilateral thyroid nodules ≤4.0cm by ultrasound, papillary thyroid carcinoma diagnosed by preoperative cytology (Bethesda grade VI) or intraoperative freezing, and planned to undergo thyroid lobectomy; (3) No clinical lymph node metastasis (cN0);No extrathyroidal extension, and the number of pathological lymph node micrometastasis (<0.2cm) was ≤5. (4) no serious medical diseases and major organ dysfunction, such as blood routine, liver, kidney, heart, lung function; No previous history of other head and neck malignancies, no history of neck radiation, no history of deep neck surgery (skin mass excision except clinical); (5) Fully understand this study, have the ability to complete treatment, have follow-up conditions and voluntarily sign informed consent. Exclusion Criteria: (1) History of malignancy in other sites (previous or simultaneous), excluding curable non-melanoma skin cancer and cervical carcinoma in situ; (2) The contralateral thyroid nodules were evaluated by preoperative ultrasound, and the patients with suspicious nodules who underwent fine-needle aspiration cytology and could not confirm the benign or malignant nodules (Bethesda grade I, III-V) were excluded. (3) Cervical lymph node metastasis was evaluated before surgery. Cytological aspiration and Tg eluent determination were performed on suspicious lymph nodes. If cytology was negative and Tg eluent was not higher than the normal range, it was not considered as exclusion criteria. The patients who were sent for intraoperative examination and showed metastasis were excluded. (4) cytological aspiration or intraoperative freezing suspected non-papillary thyroid carcinoma (follicular carcinoma, medullary carcinoma, poorly differentiated or undifferentiated carcinoma) or high-risk subtypes of papillary thyroid carcinoma (high cell type); (5) pregnant or lactating women; (6) A history of drug use or drug abuse within the past 1 year; (7) Participants who had participated in other clinical trials within 4 weeks before enrollment; (8) The patient is unable to accept the preservation of the contralateral gland or cannot cooperate with subsequent thyroid hormone replacement therapy. (9) The investigator assesses subjects who are unsuitable for the trial for other reasons, or who are not expected to complete the study.

Sites / Locations

  • Cancer Hospital, Chinese Academy of Medical ScienceRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

test group

Arm Description

The treatment goal after lobectomy was to control TSH within the normal reference range (0.4-5 mU/L)

Outcomes

Primary Outcome Measures

recurrence
recurrence-free survival

Secondary Outcome Measures

thyroid function
biochemical incomplete (rising serum Tg)

Full Information

First Posted
October 8, 2023
Last Updated
October 13, 2023
Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT06087068
Brief Title
Thyroxine Replacement Therapy After Lobectomy for Low-risk Papillary Thyroid Carcinoma
Official Title
A Prospective, Single-arm Phase II Study of Thyroxine Replacement Therapy After Lobectomy for Low-risk Papillary Thyroid Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
July 31, 2026 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Papillary thyroid carcinoma (PTC) is the most common thyroid cancer and has a good prognosis.According to the 2015 American thyroid association (ATA) guidelines, no gross extrathyroidal extension and the number of pathological lymph node micrometastases (<0.2cm) ≤5 were defined as the low recurrence risk group. After total thyroidectomy and radioiodine treatment, the probability of disease-free status (irritant Tg<1ng/ml, no evidence of other disease recurrence) is about 78%-91%, and the probability of structural recurrence is about 1%-10%. In recent years, due to the further understanding of PTC, surgeons tend to become more conservative in treatment, such as active observation or reducing the extent of surgery. The indication for lobectomy has been extended to tumors <4cm without extrathyroidal extension and clinical lymph node metastasis. For patients treated with lobectomy, current guidelines recommend that Thyroid Stimulating Hormone (TSH) be controlled at 0.5-2 mU/L, but evidence on the prognostic benefits of this TSH inhibition range is lacking.In recent years, a number of studies have suggested that if postoperative TSH in low-risk patients after lobectomy is acceptable within the reference range, it means that a considerable number of patients have a high probability of not receiving thyroxine replacement therapy after surgery, which can significantly improve their quality of life.A previous retrospective study from our institute showed no significant association between TSH levels after lobectomy and prognosis.The aim of this study was to evaluate the benefits and risks of postoperative TSH levels within the reference range (0.4-5 mU/L) in patients with low-risk papillary thyroid cancer who underwent lobectomy.In order to improve the effect of longer recurrence and death time of PTC, the investigators also performed postoperative thyroglobulin and its antibody for short-term treatment response evaluation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Cancer, Surgery, Recurrence
Keywords
thyroid cancer, lobectomy, TSH replacement, recurrence

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
The treatment goal after lobectomy was to control TSH within the normal reference range (0.4-5 mU/L)
Masking
None (Open Label)
Allocation
N/A
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
test group
Arm Type
Experimental
Arm Description
The treatment goal after lobectomy was to control TSH within the normal reference range (0.4-5 mU/L)
Intervention Type
Drug
Intervention Name(s)
Thyroxine
Intervention Description
The treatment goal after lobectomy was to control TSH within the normal reference range (0.4-5 mU/L)
Primary Outcome Measure Information:
Title
recurrence
Description
recurrence-free survival
Time Frame
2 year
Secondary Outcome Measure Information:
Title
thyroid function
Description
biochemical incomplete (rising serum Tg)
Time Frame
1 year; 2 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Months
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: (1) Age 18-70 years old, ECOG score 0-2; (2) Patients with the maximum diameter of unilateral thyroid nodules ≤4.0cm by ultrasound, papillary thyroid carcinoma diagnosed by preoperative cytology (Bethesda grade VI) or intraoperative freezing, and planned to undergo thyroid lobectomy; (3) No clinical lymph node metastasis (cN0);No extrathyroidal extension, and the number of pathological lymph node micrometastasis (<0.2cm) was ≤5. (4) no serious medical diseases and major organ dysfunction, such as blood routine, liver, kidney, heart, lung function; No previous history of other head and neck malignancies, no history of neck radiation, no history of deep neck surgery (skin mass excision except clinical); (5) Fully understand this study, have the ability to complete treatment, have follow-up conditions and voluntarily sign informed consent. Exclusion Criteria: (1) History of malignancy in other sites (previous or simultaneous), excluding curable non-melanoma skin cancer and cervical carcinoma in situ; (2) The contralateral thyroid nodules were evaluated by preoperative ultrasound, and the patients with suspicious nodules who underwent fine-needle aspiration cytology and could not confirm the benign or malignant nodules (Bethesda grade I, III-V) were excluded. (3) Cervical lymph node metastasis was evaluated before surgery. Cytological aspiration and Tg eluent determination were performed on suspicious lymph nodes. If cytology was negative and Tg eluent was not higher than the normal range, it was not considered as exclusion criteria. The patients who were sent for intraoperative examination and showed metastasis were excluded. (4) cytological aspiration or intraoperative freezing suspected non-papillary thyroid carcinoma (follicular carcinoma, medullary carcinoma, poorly differentiated or undifferentiated carcinoma) or high-risk subtypes of papillary thyroid carcinoma (high cell type); (5) pregnant or lactating women; (6) A history of drug use or drug abuse within the past 1 year; (7) Participants who had participated in other clinical trials within 4 weeks before enrollment; (8) The patient is unable to accept the preservation of the contralateral gland or cannot cooperate with subsequent thyroid hormone replacement therapy. (9) The investigator assesses subjects who are unsuitable for the trial for other reasons, or who are not expected to complete the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
jie liu
Phone
+861087787180
Email
liujie10-11@vip.163.com
Facility Information:
Facility Name
Cancer Hospital, Chinese Academy of Medical Science
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
jie liu, MD
Phone
8610-87787180

12. IPD Sharing Statement

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Thyroxine Replacement Therapy After Lobectomy for Low-risk Papillary Thyroid Carcinoma

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