Thyroid Lobectomy for Thyroid Cancer

EH
Overseen ByElena Hughes
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Jonsson Comprehensive Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new surgical approach, Thyroid Lobectomy with Ipsilateral Central Neck Dissection, to treat medullary thyroid cancer (MTC) without a RET genetic mutation. Instead of removing the entire thyroid gland, the trial tests removing only the affected part and nearby tissues. This method might lower the risk of complications and reduce the need for lifelong hormone therapy. It could be suitable for individuals diagnosed with MTC who lack the RET mutation and require surgery. As an unphased trial, it offers a unique opportunity to explore innovative surgical techniques that could potentially improve patient outcomes.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that thyroid lobectomy with ipsilateral central neck dissection is safe for treating medullary thyroid cancer?

Research has shown that thyroid lobectomy with removal of nearby neck tissue is generally well-tolerated. Similar surgeries, such as preventive neck tissue removal, carry known risks, including nerve damage, low calcium levels due to issues with nearby glands, and bleeding. These risks are also common in more extensive surgeries, like total thyroid removal.

Thyroid lobectomy involves removing only the affected part of the thyroid and some nearby tissue, making it less extensive than removing the entire thyroid. Studies comparing lobectomy with more extensive surgeries suggest that lobectomy may lead to fewer complications and a quicker recovery. For instance, one study found that patients who underwent a lobectomy experienced fewer problems than those who had their entire thyroid removed.

Overall, available data suggest that thyroid lobectomy with nearby neck tissue removal has a manageable safety profile. It is important to discuss potential risks and benefits with a healthcare provider when considering participation in a clinical trial.12345

Why are researchers excited about this trial?

Unlike the standard of care for thyroid cancer, which often involves a total thyroidectomy, this treatment focuses on a thyroid lobectomy with ipsilateral central neck dissection. This approach aims to preserve more of the thyroid gland, potentially reducing the need for lifelong thyroid hormone replacement therapy. Researchers are excited about this method because it could offer a less invasive option with fewer long-term side effects, while still effectively monitoring and treating any residual disease with follow-up imaging and blood tests. This approach not only targets cancer effectively but also emphasizes patient quality of life by minimizing unnecessary surgical interventions.

What evidence suggests that thyroid lobectomy with ipsilateral central neck dissection is effective for medullary thyroid cancer?

Research has shown that a thyroid lobectomy with removal of nearby lymph nodes, which participants in this trial will undergo, can effectively treat some thyroid cancers. Studies have found that this method can lead to survival and recurrence rates similar to those of more extensive surgeries, such as removing the entire thyroid. For example, one study found that this approach resulted in excellent survival and low recurrence rates in patients with low-risk papillary thyroid cancer. This suggests it might also work well for similar conditions, like sporadic medullary thyroid cancer (MTC). Additionally, this surgery might lower the risk of complications and reduce the need for lifelong hormone replacement therapy, often necessary after removing the entire thyroid. This could improve patients' quality of life without increasing the risk of cancer recurrence.12678

Who Is on the Research Team?

JW

James Wu, MD

Principal Investigator

UCLA / Jonsson Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for people with medullary thyroid cancer (MTC) that does not involve a hereditary RET gene mutation (sporadic MTC). Participants should have cancer limited to the thyroid and meet other medical requirements set by the study team.

Inclusion Criteria

I have signed consent and can follow the study requirements.
I am eligible for thyroid surgery to remove part or all of my thyroid.
I am 18 years old or older.
See 2 more

Exclusion Criteria

Ultrasound findings consistent with cervical lymphadenopathy involving lateral neck or contralateral central neck
Ultrasound findings consistent with suspicious thyroid nodules > 1 cm that are Thyroid Imaging Reporting and Data Systems 2 (TIRADS2) or higher without fine needle aspiration (FNA)
My nodule was tested and found to be benign.
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients undergo thyroid lobectomy with unilateral central neck dissection

Perioperative/Periprocedural
1 visit (in-person)

Follow-up

Patients undergo blood sample collection and imaging at 3 and 6 month follow-ups to monitor for biochemical or imaging evidence of persistent disease

6 months
Multiple visits (in-person)

Extended Follow-up

Patients are followed up at day 14 and months 3, 6, 12, 18, and 24 for routine cancer surveillance and additional monitoring

24 months
Multiple visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Thyroid Lobectomy with Ipsilateral Central Neck Dissection

Trial Overview

The trial is testing whether removing only the affected half of the thyroid gland, along with nearby lymph nodes on one side of the neck, works well for treating sporadic MTC. This approach is compared to more extensive surgery and includes imaging tests and follow-up monitoring.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Treatment (thyroid lobectomy, unilateral neck dissection)Experimental Treatment8 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Jonsson Comprehensive Cancer Center

Lead Sponsor

Trials
373
Recruited
35,200+

Eli Lilly and Company

Industry Sponsor

Trials
2,708
Recruited
3,720,000+
Dr. Daniel Skovronsky profile image

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks profile image

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Citations

Lobectomy vs Total Thyroidectomy With Ipsilateral Lateral ...

This cohort study compares survival and recurrence outcomes between patients who underwent a lobectomy plus ipsilateral lateral neck dissection (LND)

Prospective Comparative Randomized Study of ...

In this randomized trial, we compared the efficacy of prophylactic ipsilateral central neck dissection—whether performed or not—with complete thyroidectomy in ...

Evaluating the effectiveness of prophylactic central neck ...

Evaluating the effectiveness of prophylactic central neck dissection with total thyroidectomy for cN0 papillary thyroid carcinoma: An updated meta-analysis.

Efficacy of Central Neck Dissection for Clinically Node- ...

Results: At baseline, there was no significant difference in sex, age, and multiplicity and bilaterality of the cancer between the two groups.

Utility of prophylactic central dissection in papillary thyroid ...

In our study, performing a pCND for patients with lateral neck involvement was associated with improved recurrence-free survival and higher ...

Risk staging with prophylactic unilateral central neck ...

Ipsilateral PND upstaged low-risk cT1bT2cN0 patients to intermediate risk in only 8.6% of cases, and contralateral PND in an additional 2%.

The pros and cons of prophylactic central neck dissection in ...

The risks of pCND are the same as at thyroidectomy and include recurrent laryngeal nerve injury, hypoparathyroidism and hematoma.

Total Thyroidectomy With and Without Prophylactic Central ...

Retrospective studies have compared the postoperative TSH-stimulated Tg levels between those who underwent prophylactic central neck dissection (pCND) and those ...