Thyroid Gland Removal With or Without Central Lymph Node Dissection in Treating Patients With Node Negative Thyroid Cancer
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 117
- Locations
- 1
- Primary Endpoint
- Post-operative Serum PTH (pg/ml) at Month 6
Study Overview
Brief Summary
This phase II trial studies how well thyroid gland removal with or without central lymph node dissection works in treating patients with thyroid cancer or suspected thyroid cancer that has not spread to the lymph nodes (randomized into Arms I and II). Arms I and II are compared to a standard of care (SOC) Arm III to enable comparison of quality of life among various surgical treatments. Currently, the standard treatment for thyroid cancer is total thyroidectomy, or complete removal of the thyroid. The lymph nodes in the central part of the neck may also be surgically removed, called central lymph node dissection. Prophylactic removal of the lymph nodes may increase the risk of life-threatening complications, and may reduce post-surgery quality of life. It may also prevent the cancer from returning and reduce the need for additional surgery. It is not yet known whether recurrence rates and complication levels are lower after thyroid gland removal alone or with central lymph node dissection.
Detailed Description
PRIMARY OBJECTIVES:
I. To determine the rate of transient and permanent hypocalcemia
SECONDARY OBJECTIVES:
I. To determine the rate of voice and swallowing problems.
II. To determine the degree to which quality of life (QOL) is compromised.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 21 Years to 73 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Pre-operative diagnosis or suspicion of papillary thyroid cancer, usually by fine needle aspiration (FNA)
- •No pre-operative evidence of cervical lymph node metastases on neck ultrasound (randomization arms only)
- •No evidence of distant metastases
- •Ability to read and write in English
Exclusion Criteria
- •Largest papillary thyroid carcinoma < 1 cm in size on ultrasound
- •Previous thyroid surgery
- •Concurrent active malignancy of another type
- •Inability to give informed consent or lacks decision making capacity
- •Pre-existing vocal cord paralysis
- •Chronic neurologic condition which affects voice or swallow (for instance, multiple sclerosis or Parkinson disease)
- •Baseline laryngeal pathology that would warrant intervention that could affect voice or swallow function
- •Becomes pregnant before surgery or at any time while on study
- •INTRA-OPERATION EXCLUSION CRITERIA (randomization arms only)
- •Evidence of nodal involvement identified in the operating room (OR)
- •Failure to confirm diagnosis of cancer in participant
Arms & Interventions
Arm I (no CND)
Patients undergo total thyroidectomy alone.
Intervention: Thyroidectomy (Procedure)
Arm I (no CND)
Patients undergo total thyroidectomy alone.
Intervention: Quality-of-life assessment (Other)
Arm II (CND)
Patients undergo total thyroidectomy with ipsilateral prophylactic CND.
Intervention: Thyroidectomy (Procedure)
Arm II (CND)
Patients undergo total thyroidectomy with ipsilateral prophylactic CND.
Intervention: entral lymph node dissection (CLND) (Procedure)
Arm II (CND)
Patients undergo total thyroidectomy with ipsilateral prophylactic CND.
Intervention: Quality-of-life assessment (Other)
Arm III (SOC)
Patients who are not eligible for randomization into Arm I or Arm II, Standard of Care (SOC) group. No specific trial intervention, treated as per patient and physician preference
Intervention: Quality-of-life assessment (Other)
Outcomes
Primary Outcomes
Post-operative Serum PTH (pg/ml) at Month 6
Time Frame: At Month 6
Number of Participants With Hypocalcemia Symptoms in First 2 Weeks
Time Frame: 2 weeks
Number of participants with hypocalcemia symptoms and symptom severity in first two weeks, as defined by presence of clinically significant symptoms of hypocalcemia. Clinically significant symptoms defined as 1 or more episodes of symptoms of hypocalcemia per day for multiple days, symptoms leading to calls to provider for assistance with managing and/or symptoms leading to escalation of dosage of prescribed medications to treat symptoms of hypocalcemia
Post-operative Serum Calcium (mg/dL) at Day 12
Time Frame: At day 12
Post-operative serum calcium (mg/dL) at Day 12
Total Calcium Consumption in First 2 Weeks
Time Frame: 2 weeks after surgery
Total calcium consumption in first 2 weeks (total mg). Participants were given calcium symptom logs in which to record their calcium consumption between surgery and their first preoperative follow up appointment, approximately two week.
Hypocalcemia Symptom Severity Scale (Range of 1-5)
Time Frame: 2 weeks post surgery
Mean number of occurrences of mild (severity 1 - 2) and severe (severity 3 - 5) hypocalcemia symptoms. Participants were asked to record hypocalcemia symptoms between surgery and first postoperative follow-up at approximately two weeks in their provided calcium symptom logs and rank severity on scale of 1 (mild) to 5 (severe).
Percentage of Participants That Required Calcium and Calcitriol at Month 6
Time Frame: At Month 6
Requirement for calcium and calcitriol at Month 6 (or, if laboratory values at visit reveal calcium \< 8 mg/dL and PTH \<15 pg/ml)
Post-operative Serum Calcium Level at Month 6
Time Frame: At Month 6
Post-operative serum calcium (mg/dL) at Month 6
Percentage of Participants With Transient Hypoparathyroidism, as Defined by a Day 1 Serum Parathyroid Hormone (PTH) Level of < 10 pg/ml
Time Frame: Post-operative day 1
Rate of transient hypoparathyroidism will be assessed in terms of percentage of participants with day 1 serum PTH level of \< 10 pg/ml.
Secondary Outcomes
- Degree to Which Accurate Quality of Life (QOL) Measures Can be Extracted From Patient Interview Narratives Using Natural Language Processing Techniques(Post-operative day 1 - up to 1 year)
- Clinical Recurrence Rates(Week 6 - up to 5 years)
- Rate of Transient and Permanent Hypocalcemia(Post-operative day 1 - Month 6)
- Degree to Which Quality of Life (QOL) is Compromised(Post-operative day 1 - up to 1 year)
- Rate of Voice and Swallowing Problems(Post operative day 1 - up to 1 year)