COACH - Comparing Two Different Methods to Suppress Thyrotropin in Patients With Advanced Thyroid Cancer

Launched by AHS CANCER CONTROL ALBERTA · Jan 22, 2025

Keywords

ClinConnect Summary

The COACH trial is studying two different ways to manage thyroid-stimulating hormone (TSH) levels in patients with advanced thyroid cancer. Typically, doctors aim to keep TSH levels below 0.1 mU/L because high levels may encourage cancer growth. However, this trial will investigate whether it's just as safe and effective to keep TSH levels between 0.1 and 0.5 mU/L. The goal is to find a balance that may lead to fewer side effects for patients while still effectively treating their cancer.

To participate in this study, you need to be at least 18 years old and have advanced differentiated thyroid cancer that cannot be surgically removed. You also need to be living in Alberta and willing to visit the Cross Cancer Institute in Edmonton. If you qualify, you will receive treatment and follow-up care as part of the study. The trial is not yet recruiting participants, but if successful, it could change how doctors manage TSH levels in thyroid cancer patients, aiming for better outcomes and less discomfort.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Minimum age of 18 years, with no upper limit of age.
• • 2. ECOG 0-2
• • 3. Patients must be capable of providing consent to enrollment and willing to comply with study treatment and follow-up.
• • 4. Diagnosis of differentiated thyroid cancer (including papillary, follicular, oncocytic, and poorly differentiated subtypes) with advanced structural disease (defined as unresectable persistent/ recurrent locoregional disease and/or distant metastases).
• • 5. Residence within Alberta and referral to the Cross Cancer Institute in Edmonton, for consideration of anticancer therapy and/or follow-up.
• • 6. Absence of any condition hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the study.
• • 7. Patients of childbearing / reproductive potential should use highly effective birth control methods, as defined by the investigator, during the study treatment period and for a period of 30 days after the last dose of study drug. A highly effective method of birth control is defined as those resulting in low failure rate (i.e., less than 1% per year) when used consistently and correctly.
• • Note: abstinence is acceptable if this is established and preferred contraception for the patient.
• • 8. Women of childbearing potential (WOCBP) must have a negative serum (or urine) pregnancy test at the time of screening. WOCBP is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy or bilateral salpingectomy) and is not postmenopausal. Menopause is defined as 12 months of amenorrhea in a woman over age 45 years in the absence of other biological or physiological causes. In addition, females under the age of 55 years must have a serum follicle stimulating hormone, (FSH) level \> 40 mIU/mL to confirm menopause.
• • 9. Females must not be breastfeeding (timeframe: during study treatment period and for a period of 30 days after the last dose of the study drug).
• • 10. Ability to obtain sufficient thyroid cancer tissue to conduct baseline NGS testing (could be fresh or archived tissue).
• Exclusion Criteria:
• • 1. Recent acute coronary event (within 6 months of randomization).
• • 2. History of atrial fibrillation.
• • 3. Known hypersensitivity to levothyroxine.
• • - Treatment with other investigational drugs within 30 days prior to randomization.
• • 4. History of fragility fractures or established diagnosis of osteoporosis.
• • Prior treatment with levothyroxine before study entry at any dose and with any TSH target is not an exclusion criterion.