Central Neck Dissection in Patients With Clinical Node Negative Thyroid Cancer
| Status: | Recruiting |
|---|---|
| Conditions: | Endocrine |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 21 - 73 |
| Updated: | 8/5/2018 |
| Start Date: | June 2014 |
| End Date: | December 2020 |
| Contact: | Cancer Connect |
| Email: | cancerconnect@uwcarbone.wisc.edu |
| Phone: | (800) 622-8922 |
Thyroid Gland Removal With or Without Central Lymph Node Dissection in Treating Patients With Node Negative Thyroid Cancer
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.
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.
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.
III. To determine the degree to which accurate quality of life measures can be extracted from
patient interview narratives using natural language processing techniques.
IV. To determine clinical recurrence rates.
OUTLINE: Patients are randomized to 1 of 2 treatment arms, if ineligible into a SOC arm.
ARM I: Patients undergo total thyroidectomy alone.
ARM II: Patients undergo total thyroidectomy with ipsilateral prophylactic central neck
dissection (CND).
ARM III: Patients ineligible to be randomized into ARM I or II, Standard of Care (SOC)
comparator receiving same follow up.
After completion of study treatment, patients are followed up at day 1, 2 and 6 weeks, and 6
and 12 months.
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.
III. To determine the degree to which accurate quality of life measures can be extracted from
patient interview narratives using natural language processing techniques.
IV. To determine clinical recurrence rates.
OUTLINE: Patients are randomized to 1 of 2 treatment arms, if ineligible into a SOC arm.
ARM I: Patients undergo total thyroidectomy alone.
ARM II: Patients undergo total thyroidectomy with ipsilateral prophylactic central neck
dissection (CND).
ARM III: Patients ineligible to be randomized into ARM I or II, Standard of Care (SOC)
comparator receiving same follow up.
After completion of study treatment, patients are followed up at day 1, 2 and 6 weeks, and 6
and 12 months.
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
- T4 tumor
- 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
We found this trial at
1
site
Madison, Wisconsin 53792
(608) 263-2400
Principal Investigator: Rebecca S. Sippel
University of Wisconsin In achievement and prestige, the University of Wisconsin–Madison has long been recognized...
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