Thyroid Lobectomy for Thyroid Cancer
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.12345Why 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?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Patients undergo thyroid lobectomy with unilateral central neck dissection
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
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
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
Patients undergo thyroid lobectomy with unilateral central neck dissection on study. Patients then undergo blood sample collection for calcitonin and CEA monitoring with neck ultrasound and/or Ga-68 or FDG PET/CT at 3 and 6 month follow-ups. Patients with no biochemical or imaging evidence of persistent disease undergo routine cancer surveillance. Patients with either of the following: 1) Elevated or rising calcitonin and/or CEA plus imaging suggestive of residual disease in the contralateral thyroid lobe or contralateral cervical lymph nodes, or 2) Elevated or rising calcitonin and/or CEA with negative imaging for an alternate source, consistent with biochemical evidence of residual disease in the remaining thyroid lobe, may undergo completion thyroidectomy and/or contralateral neck dissection during follow up. Patients also undergo additional blood sample collection, neck ultrasound, and/or Ga-68 or FDG PET/CT throughout the study.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Jonsson Comprehensive Cancer Center
Lead Sponsor
Eli Lilly and Company
Industry Sponsor
Dr. Daniel Skovronsky
Eli Lilly and Company
Chief Medical Officer since 2018
MD from Harvard Medical School
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 ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.