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Clinical Trial Options

Clinical Outline

Educational Clips from TIROxMDS
Reasons to Enter Patients into Clinical Trials

= Primers in Thyroidology

= Journal Club Presentation

= Case-based Discussion (inc. roundtables)

= Grand Rounds Lectureship

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Reasons to Enter Patients into Clinical Trials

ATA // ESMO // NCCN

High-quality clinical trials for patients with radioiodine refractory differentiated thyroid cancer are important to address clinical uncertainties. A therapeutic clinical trial is a systematic investigation of the effectiveness and safety of a potential new or modified treatment or combination of treatments, potentially including medications (including radioiodine), surgery, radiation therapy, and/or other novel or revised approaches. A broad variety of such trials may exist at any given time.​1–3​

Clinical trial participation is strongly encouraged for all patients with thyroid cancer in need of treatment, especially when standard treatment options offer limited efficacy and/or risk significant treatment-related morbidity.​1–3​

Clinicians considering referral of patients for trials should review available treatment options and eligibility criteria, preferably through discussions with trial center personnel and review of trial materials at the website: www.clinicaltrials.gov.​1–3​

The complexity of multidisciplinary treatment and the availability of prospective clinical trials should encourage the clinician to refer patients with structurally progressive Radioiodine Refractory Differentiated Thyroid Cancer  (RR-DTC) to tertiary centers with particular expertise when feasible.​1​

Molecular testing for tumor genotype has been shown to be beneficial when making targeted therapy decisions, including clinical trial participation, based on NCCN guidelines. ATA guidelines, however, state, “routine mutation profiling cannot be recommended at this time outside of research settings.”​1,3​

Medullary Thyroid Cancer

Clinical trials have advanced much of what we know today in medullary thyroid carcinoma and ongoing and future trials will be vital to advancing our knowledge and finding a cure for medullary thyroid carcinoma. 

Given that patients with medullary thyroid carcinoma have no cure other than surgery, clinical trials should be considered for treatment of distant metastatic disease and unresectable/ incurable medullary thyroid carcinoma. Clinical trials using radiolabeled therapies, targeted therapies or neoadjuvant therapies are underway and soon to be published. ​1–4​

Expert Commentary 

Given the available systemic therapies are not cures, progression is inevitable. There is not much known about the mechanisms of resistance at the time of progression. Therefore, biopsy of progressing lesions would be recommended at the time of progression for biomarker testing and determine potential new therapies.

In addition, many of these therapies are taken for long durations, quality of life measures are important. Patient reported outcome measures are encouraged to be investigated and incorporated in clinical trials. 

References

  1. 1.
    Haugen B, Alexander E, Bible K, et al. 2015 American Thyroid Association Management Guidelines for Adult Patients with Thyroid Nodules and Differentiated Thyroid Cancer: The American Thyroid Association Guidelines Task Force on Thyroid Nodules and Differentiated Thyroid Cancer. Thyroid. 2016;26(1):1-133. doi:10.1089/thy.2015.0020
  2. 2.
    Filetti S, Durante C, Hartl D, et al. Thyroid cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up†. Ann Oncol. 2019;30(12):1856-1883. doi:10.1093/annonc/mdz400
  3. 3.
    Haddad RI, Nasr C, Bischoff L, et al. NCCN Guidelines Insights: Thyroid Carcinoma, Version 2.2018. J Natl Compr Canc Netw. Published online December 2018:1429-1440. doi:10.6004/jnccn.2018.0089
  4. 4.
    Ito Y, Onoda N, Okamoto T. The revised clinical practice guidelines on the management of thyroid tumors by the Japan Associations of Endocrine Surgeons: Core questions and recommendations for treatments of thyroid cancer. Endocr J. 2020;67(7):669-717. doi:10.1507/endocrj.EJ20-0025