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NCT06475989 · ClinicalTrials.gov registry record · Phase 3
Study of Targeted Therapy vs. Chemotherapy in Patients With Thyroid Cancer
A Phase 3 study of Refractory Differentiated Thyroid Gland Carcinoma, sponsored by ECOG-ACRIN Cancer Research Group.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 264
- Enrollment target
- 20
- Study locations
NCT06475989: Recruiting Phase 3 study of Refractory Differentiated Thyroid Gland Carcinoma, sponsored by ECOG-ACRIN Cancer Research Group.
NCT06475989 is a Phase 3 study of Refractory Differentiated Thyroid Gland Carcinoma that is actively recruiting participants, run by ECOG-ACRIN Cancer Research Group. The registered enrollment target is 264 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (66% lower). The trial reports 20 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06475989, a Phase 3 study of Refractory Differentiated Thyroid Gland Carcinoma, is actively recruiting participants, sponsored by ECOG-ACRIN Cancer Research Group.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 264 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase III trial compares the effect of cabozantinib versus combination dabrafenib and trametinib for the treatment of patients with differentiated thyroid cancer that does not respond to treatment (refractory) and which expresses a BRAF V600E mutation. Cabozantinib is in a class of medications called receptor tyrosine kinase inhibitors. It binds to and blocks the action of several enzymes which are often over-expressed in a variety of tumor cell types. This may help stop or slow the growth of tumor cells and blood vessels the tumor needs to survive. Dabrafenib is an enzyme inhibitor that binds to and inhibits the activity of a protein called B-raf, which may inhibit the proliferation of tumor cells which contain a mutated BRAF gene. Trametinib is also an enzyme inhibitor. It binds to and inhibits the activity of proteins called MEK 1 and 2, which play a key role in activating pathways that regulate cell growth. This may inhibit the growth of tumor cells mediated by these pathways. The usual approach for patients with thyroid cancer is targeted therapy with dabrafenib and trametinib. This trial may help researchers decide which treatment option (cabozantinib alone or dabrafenib in combination with trametinib) is safer and/or more effective in treating patients with refractory BRAF V600E-mutated differentiated thyroid cancer.
Primary Outcome
PFS will be compared between the two groups using a stratified log-rank test with one-sided type I error of 0.05. Median PFS and 95% confidence interval (CI) for each treatment arm will be estimated using the Kaplan-Meier method. The stratified hazard ratio and 95% CI will be estimated using a Cox proportional hazard model with treatment group as the independent variable.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Magnetic Resonance Imaging
- DRUG Cabozantinib
- DRUG Dabrafenib
Study Locations (20)
Connecticut
- Smilow Cancer Hospital-Derby Care Center - Derby
- Smilow Cancer Hospital Care Center-Fairfield - Fairfield
- Smilow Cancer Hospital Care Center at Glastonbury - Glastonbury
- Smilow Cancer Hospital Care Center at Greenwich - Greenwich
- Smilow Cancer Hospital Care Center - Guilford - Guilford
- Smilow Cancer Hospital Care Center at Saint Francis - Hartford
- Smilow Cancer Center/Yale-New Haven Hospital - New Haven
- Yale University - New Haven
- Yale-New Haven Hospital North Haven Medical Center - North Haven
- Smilow Cancer Hospital Care Center at Long Ridge - Stamford
- Smilow Cancer Hospital-Torrington Care Center - Torrington
- Smilow Cancer Hospital Care Center-Trumbull - Trumbull
- Smilow Cancer Hospital-Waterbury Care Center - Waterbury
- Smilow Cancer Hospital Care Center - Waterford - Waterford
Idaho
- Saint Alphonsus Cancer Care Center-Boise - Boise
- Saint Alphonsus Cancer Care Center-Caldwell - Caldwell
- Kootenai Health - Coeur d'Alene - Coeur d'Alene
- Walter Knox Memorial Hospital - Emmett
Arkansas
- Mercy Hospital Fort Smith - Fort Smith
- CARTI Cancer Center - Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 264 participants |
| Start Date | 2024-08-22 |
| Est. Completion | 2030-09-30 |
| Phase | Phase 3 |
What NCT06475989 shows while recruiting
NCT06475989 is an interventional study that assigns participants to a tested intervention. The registered 264 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (66% lower).
The record links to 1 condition, with Refractory Differentiated Thyroid Gland Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT06475989 names 20 study sites across 3 states, led by Connecticut, Idaho, Arkansas.
Frequently Asked Questions
What is clinical trial NCT06475989 about?
NCT06475989 is a clinical study titled "Study of Targeted Therapy vs. Chemotherapy in Patients With Thyroid Cancer". This phase III trial compares the effect of cabozantinib versus combination dabrafenib and trametinib for the treatment of patients with differentiated thyroid cancer that does not respond to treatment (refractory) and which expresses a BRAF V600E mutation. Cabozantinib is in a class of medications ...
What is the current status of trial NCT06475989?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 264 participants. The study started on 2024-08-22. Estimated completion is 2030-09-30.
What conditions does trial NCT06475989 study?
This clinical trial studies the following conditions: Refractory Differentiated Thyroid Gland Carcinoma.
What interventions are being tested in trial NCT06475989?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Magnetic Resonance Imaging (PROCEDURE), Cabozantinib (DRUG), Dabrafenib (DRUG).
Who is sponsoring clinical trial NCT06475989?
This trial is sponsored by ECOG-ACRIN Cancer Research Group, which has 75 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06475989 being conducted?
This trial has 20 study locations across Arkansas, Connecticut, Idaho. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Refractory Differentiated Thyroid Gland Carcinoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06475989's enrollment target sits among peer trials
264 1226th of 2000 higher than 773 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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