Study Comparing Targeted Therapy and Chemotherapy for Thyroid Cancer
Sponsor: ECOG-ACRIN Cancer Research Group
ClinicalTrials ID:NCT06475989
This clinical trial is exploring whether the drug cabozantinib or a combination of dabrafenib and trametinib is more effective in treating thyroid cancer that has a specific genetic mutation and does not respond to standard treatments.
Patient Parameters
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Program Overview
This study is testing two different treatment options for patients with a type of thyroid cancer that has a specific mutation (BRAF V600E) and does not respond to usual treatments. The trial compares cabozantinib, a drug that blocks certain enzymes to slow tumor growth, with a combination of dabrafenib and trametinib, which target proteins involved in cancer cell growth. Researchers aim to find out which treatment is safer and more effective.
Description
The main goal of this study is to see which treatment helps patients live longer without their cancer getting worse. Researchers will also look at how well the cancer responds to each treatment, how long the response lasts, and overall survival rates. They will also assess the safety and side effects of each treatment.
Patients will be randomly assigned to one of two groups:
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Group A: Patients will take dabrafenib twice a day and trametinib once a day. This cycle repeats every 28 days as long as the treatment is working and side effects are manageable. Patients will have regular CT scans, blood tests, and possibly MRI scans.
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Group B: Patients will take cabozantinib once a day. This cycle also repeats every 28 days under the same conditions as Group A. Patients will undergo the same tests as those in Group A.
After finishing the study treatment, patients will have follow-up visits every 3 months for 2 years, then every 6 months for up to 5 years.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Must have a specific type of thyroid cancer with a BRAF V600E mutation.
- Must have tried or be ineligible for Iodine-131 treatment and be on thyroxine suppression therapy.
- Must have previously been treated with certain cancer drugs like lenvatinib or sorafenib.
- Must have measurable cancer that has shown growth after previous treatments.
- Must not have serious heart conditions or uncontrolled high blood pressure.
- Must not have had recent significant bleeding or certain lung conditions.
- Must not be on certain blood thinners, except for low-dose aspirin or stable anticoagulation.
- Must not have gastrointestinal issues that increase the risk of complications.
- Must have completed any prior local cancer treatments at least 4 weeks before starting the study.
- Must not have had major surgery within 8 weeks before starting the study.
- Must not have rapidly growing tumors or anaplastic thyroid cancer.
- Must not have been treated with cabozantinib or BRAF-targeted therapy before.
- Must not be pregnant or breastfeeding and must agree to use effective birth control during and after the study.
- Must be able to understand and sign a consent form.
- Must meet specific blood and organ function criteria.
- Must not have active infections like HIV or hepatitis unless well-controlled.
- Must have stable brain metastases if present.
- Must not have other cancers that could interfere with the study.
- Must have a specific heart rhythm measurement within normal limits.
- Must speak English or Spanish for the quality of life part of the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Mercy Hospital Fort Smith | 72903 | Fort Smith | Arkansas |
| CARTI Cancer Center | 72205 | Little Rock | Arkansas |
| Smilow Cancer Hospital-Derby Care Center | 06418 | Derby | Connecticut |
| Smilow Cancer Hospital Care Center-Fairfield | 06824 | Fairfield | Connecticut |
| Smilow Cancer Hospital Care Center at Glastonbury | 06033 | Glastonbury | Connecticut |
| Smilow Cancer Hospital Care Center at Greenwich | 06830 | Greenwich | Connecticut |
| Smilow Cancer Hospital Care Center - Guilford | 06437 | Guilford | Connecticut |
| Smilow Cancer Hospital Care Center at Saint Francis | 06105 | Hartford | Connecticut |
| Smilow Cancer Center/Yale-New Haven Hospital | 06510 | New Haven | Connecticut |
| Yale University | 06520 | New Haven | Connecticut |
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