Actively Recruiting
Study of Targeted Therapy vs. Chemotherapy in Patients With Thyroid Cancer
Led by ECOG-ACRIN Cancer Research Group · Updated on 2026-05-05
264
Participants Needed
112
Research Sites
318 weeks
Total Duration
On this page
Sponsors
E
ECOG-ACRIN Cancer Research Group
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of Targeted Therapy vs. Chemotherapy in Patients With Thyroid Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient must be 18 years of age or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Differentiated thyroid cancer with BRAF V600E mutation confirmed by local testing
- Previously treated with or ineligible for Iodine-131 therapy and receiving thyroxine suppression
- Prior treatment with at least one VEGFR-targeting tyrosine kinase inhibitor such as lenvatinib or sorafenib
- Measurable disease by RECIST 1.1 on imaging within 4 weeks before randomization
- Radiographic disease progression after most recent systemic treatment
- No serious cardiovascular or thromboembolic conditions as specified
- No clinically significant bleeding or cavitating pulmonary lesions
- Not using oral anticoagulants or platelet inhibitors except allowed low-dose aspirin or stable therapeutic anticoagulation
- No high-risk gastrointestinal disorders or recent abdominal complications
- Completed prior local therapy at least 4 weeks before randomization with healed wounds
- No major surgery within 8 weeks prior to randomization with healed wounds
- No lesions with rapid growth or documented anaplastic histology at recurrence
- No prior treatment with cabozantinib or BRAF-targeted therapy for thyroid cancer
- Not pregnant or breastfeeding; use effective contraception if of childbearing potential
- Ability to understand and sign informed consent
- Adequate blood counts and organ function within 28 days prior to randomization
- HIV patients with undetectable viral load on therapy eligible
- Hepatitis B patients with undetectable viral load on therapy eligible
- Hepatitis C patients treated and cured or with undetectable viral load if on treatment
- Stable treated brain metastases with no progression for at least 4 weeks
- Prior or concurrent malignancies allowed if not interfering with study
- Corrected QT interval (QTcF) ≤ 500 ms within 28 days prior to randomization
- English or Spanish speaking for quality of life assessment
You will not qualify if you...
- Congestive heart failure class 3 or 4, unstable angina, or serious cardiac arrhythmias
- Uncontrolled hypertension despite treatment
- Stroke, heart attack, or thromboembolic event within 6 months prior to randomization unless stable
- Clinically significant hematemesis or hemoptysis within 3 months prior to randomization
- Cavitating pulmonary lesions or lesions invading major pulmonary vessels
- Use of oral anticoagulants or platelet inhibitors not allowed except specified exceptions
- Gastrointestinal disorders with high risk of perforation or fistula within 6 months prior to randomization
- Major surgery within 8 weeks prior to randomization without complete healing
- Lesion growth greater than specified thresholds within 2-3 months prior to randomization
- Documented anaplastic histology at or after recurrence
- Prior treatment with cabozantinib or BRAF targeted therapy for thyroid cancer
- Pregnant or breastfeeding women
- Inability to provide informed consent or no legally authorized representative available
- QTcF interval greater than 500 ms on ECG after repeat testing
- Non-English or non-Spanish speakers for quality of life component
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 112 locations
1
Mercy Hospital Fort Smith
Fort Smith, Arkansas, United States, 72903
Actively Recruiting
2
CARTI Cancer Center
Little Rock, Arkansas, United States, 72205
Actively Recruiting
3
Smilow Cancer Hospital-Derby Care Center
Derby, Connecticut, United States, 06418
Actively Recruiting
4
Smilow Cancer Hospital Care Center-Fairfield
Fairfield, Connecticut, United States, 06824
Actively Recruiting
5
Smilow Cancer Hospital Care Center at Glastonbury
Glastonbury, Connecticut, United States, 06033
Actively Recruiting
6
Smilow Cancer Hospital Care Center at Greenwich
Greenwich, Connecticut, United States, 06830
Actively Recruiting
7
Smilow Cancer Hospital Care Center - Guilford
Guilford, Connecticut, United States, 06437
Actively Recruiting
8
Smilow Cancer Hospital Care Center at Saint Francis
Hartford, Connecticut, United States, 06105
Actively Recruiting
9
Smilow Cancer Center/Yale-New Haven Hospital
New Haven, Connecticut, United States, 06510
Actively Recruiting
10
Yale University
New Haven, Connecticut, United States, 06520
Actively Recruiting
11
Yale-New Haven Hospital North Haven Medical Center
North Haven, Connecticut, United States, 06473
Actively Recruiting
12
Smilow Cancer Hospital Care Center at Long Ridge
Stamford, Connecticut, United States, 06902
Actively Recruiting
13
Smilow Cancer Hospital-Torrington Care Center
Torrington, Connecticut, United States, 06790
Actively Recruiting
14
Smilow Cancer Hospital Care Center-Trumbull
Trumbull, Connecticut, United States, 06611
Actively Recruiting
15
Smilow Cancer Hospital-Waterbury Care Center
Waterbury, Connecticut, United States, 06708
Actively Recruiting
16
Smilow Cancer Hospital Care Center - Waterford
Waterford, Connecticut, United States, 06385
Actively Recruiting
17
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, United States, 83706
Actively Recruiting
18
Saint Alphonsus Cancer Care Center-Caldwell
Caldwell, Idaho, United States, 83605
Actively Recruiting
19
Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho, United States, 83814
Actively Recruiting
20
Walter Knox Memorial Hospital
Emmett, Idaho, United States, 83617
Suspended
21
Idaho Urologic Institute-Meridian
Meridian, Idaho, United States, 83642
Actively Recruiting
22
Saint Alphonsus Cancer Care Center-Nampa
Nampa, Idaho, United States, 83687
Actively Recruiting
23
Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho, United States, 83854
Actively Recruiting
24
Kootenai Clinic Cancer Services - Sandpoint
Sandpoint, Idaho, United States, 83864
Actively Recruiting
25
OSF Saint Anthony's Health Center
Alton, Illinois, United States, 62002
Actively Recruiting
26
Saint Mary's Hospital
Centralia, Illinois, United States, 62801
Actively Recruiting
27
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
28
University of Illinois
Chicago, Illinois, United States, 60612
Actively Recruiting
29
Northwestern Medicine Cancer Center Kishwaukee
DeKalb, Illinois, United States, 60115
Actively Recruiting
30
Northwestern Medicine Cancer Center Delnor
Geneva, Illinois, United States, 60134
Actively Recruiting
31
Northwestern Medicine Glenview Outpatient Center
Glenview, Illinois, United States, 60026
Actively Recruiting
32
Northwestern Medicine Grayslake Outpatient Center
Grayslake, Illinois, United States, 60030
Actively Recruiting
33
Northwestern Medicine Lake Forest Hospital
Lake Forest, Illinois, United States, 60045
Actively Recruiting
34
Good Samaritan Regional Health Center
Mount Vernon, Illinois, United States, 62864
Actively Recruiting
35
Northwestern Medicine Orland Park
Orland Park, Illinois, United States, 60462
Actively Recruiting
36
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois, United States, 60555
Actively Recruiting
37
Mercy Hospital
Cedar Rapids, Iowa, United States, 52403
Actively Recruiting
38
Oncology Associates at Mercy Medical Center
Cedar Rapids, Iowa, United States, 52403
Actively Recruiting
39
Central Care Cancer Center - Garden City
Garden City, Kansas, United States, 67846
Actively Recruiting
40
Central Care Cancer Center - Great Bend
Great Bend, Kansas, United States, 67530
Actively Recruiting
41
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota, United States, 56601
Actively Recruiting
42
Minnesota Oncology - Burnsville
Burnsville, Minnesota, United States, 55337
Actively Recruiting
43
Cambridge Medical Center
Cambridge, Minnesota, United States, 55008
Actively Recruiting
44
Mercy Hospital
Coon Rapids, Minnesota, United States, 55433
Actively Recruiting
45
Fairview Southdale Hospital
Edina, Minnesota, United States, 55435
Actively Recruiting
46
Fairview Clinics and Surgery Center Maple Grove
Maple Grove, Minnesota, United States, 55369
Actively Recruiting
47
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, United States, 55109
Actively Recruiting
48
Saint John's Hospital - Healtheast
Maplewood, Minnesota, United States, 55109
Actively Recruiting
49
Abbott-Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
Actively Recruiting
50
Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55415
Actively Recruiting
51
Health Partners Inc
Minneapolis, Minnesota, United States, 55454
Actively Recruiting
52
Monticello Cancer Center
Monticello, Minnesota, United States, 55362
Actively Recruiting
53
New Ulm Medical Center
New Ulm, Minnesota, United States, 56073
Actively Recruiting
54
Fairview Northland Medical Center
Princeton, Minnesota, United States, 55371
Actively Recruiting
55
North Memorial Medical Health Center
Robbinsdale, Minnesota, United States, 55422
Actively Recruiting
56
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, United States, 55416
Actively Recruiting
57
Regions Hospital
Saint Paul, Minnesota, United States, 55101
Actively Recruiting
58
United Hospital
Saint Paul, Minnesota, United States, 55102
Actively Recruiting
59
Saint Francis Regional Medical Center
Shakopee, Minnesota, United States, 55379
Actively Recruiting
60
Lakeview Hospital
Stillwater, Minnesota, United States, 55082
Actively Recruiting
61
Sanford Thief River Falls Medical Center
Thief River Falls, Minnesota, United States, 56701
Actively Recruiting
62
Ridgeview Medical Center
Waconia, Minnesota, United States, 55387
Actively Recruiting
63
Rice Memorial Hospital
Willmar, Minnesota, United States, 56201
Actively Recruiting
64
Minnesota Oncology Hematology PA-Woodbury
Woodbury, Minnesota, United States, 55125
Actively Recruiting
65
Sanford Cancer Center Worthington
Worthington, Minnesota, United States, 56187
Actively Recruiting
66
Fairview Lakes Medical Center
Wyoming, Minnesota, United States, 55092
Actively Recruiting
67
Saint Louis Cancer and Breast Institute-Ballwin
Ballwin, Missouri, United States, 63011
Actively Recruiting
68
Central Care Cancer Center - Bolivar
Bolivar, Missouri, United States, 65613
Actively Recruiting
69
Cox Cancer Center Branson
Branson, Missouri, United States, 65616
Actively Recruiting
70
Southeast Cancer Center
Cape Girardeau, Missouri, United States, 63703
Actively Recruiting
71
Freeman Health System
Joplin, Missouri, United States, 64804
Actively Recruiting
72
Mercy Hospital Joplin
Joplin, Missouri, United States, 64804
Actively Recruiting
73
Lake Regional Hospital
Osage Beach, Missouri, United States, 65065
Actively Recruiting
74
Delbert Day Cancer Institute at PCRMC
Rolla, Missouri, United States, 65401
Actively Recruiting
75
Mercy Clinic-Rolla-Cancer and Hematology
Rolla, Missouri, United States, 65401
Actively Recruiting
76
Heartland Regional Medical Center
Saint Joseph, Missouri, United States, 64506
Actively Recruiting
77
Mercy Hospital Springfield
Springfield, Missouri, United States, 65804
Actively Recruiting
78
CoxHealth South Hospital
Springfield, Missouri, United States, 65807
Actively Recruiting
79
Saint Louis Cancer and Breast Institute-South City
St Louis, Missouri, United States, 63109
Actively Recruiting
80
Mercy Hospital South
St Louis, Missouri, United States, 63128
Actively Recruiting
81
Mercy Hospital Saint Louis
St Louis, Missouri, United States, 63141
Actively Recruiting
82
Mercy Hospital Washington
Washington, Missouri, United States, 63090
Actively Recruiting
83
Community Hospital of Anaconda
Anaconda, Montana, United States, 59711
Actively Recruiting
84
Billings Clinic Cancer Center
Billings, Montana, United States, 59101
Actively Recruiting
85
Bozeman Health Deaconess Hospital
Bozeman, Montana, United States, 59715
Actively Recruiting
86
Benefis Sletten Cancer Institute
Great Falls, Montana, United States, 59405
Actively Recruiting
87
Great Falls Clinic
Great Falls, Montana, United States, 59405
Actively Recruiting
88
Logan Health Medical Center
Kalispell, Montana, United States, 59901
Actively Recruiting
89
Community Medical Center
Missoula, Montana, United States, 59804
Actively Recruiting
90
Sanford Bismarck Medical Center
Bismarck, North Dakota, United States, 58501
Actively Recruiting
91
Sanford South University Medical Center
Fargo, North Dakota, United States, 58103
Actively Recruiting
92
Southpointe-Sanford Medical Center Fargo
Fargo, North Dakota, United States, 58103
Actively Recruiting
93
Sanford Medical Center Fargo
Fargo, North Dakota, United States, 58104
Actively Recruiting
94
Sanford Broadway Medical Center
Fargo, North Dakota, United States, 58122
Actively Recruiting
95
Sanford Roger Maris Cancer Center
Fargo, North Dakota, United States, 58122
Actively Recruiting
96
Mercy Hospital Oklahoma City
Oklahoma City, Oklahoma, United States, 73120
Actively Recruiting
97
Saint Alphonsus Cancer Care Center-Baker City
Baker City, Oregon, United States, 97814
Actively Recruiting
98
Saint Alphonsus Cancer Care Center-Ontario
Ontario, Oregon, United States, 97914
Actively Recruiting
99
UPMC Hillman Cancer Center Erie
Erie, Pennsylvania, United States, 16505
Actively Recruiting
100
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
101
Smilow Cancer Hospital Care Center - Westerly
Westerly, Rhode Island, United States, 02891
Actively Recruiting
102
Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota, United States, 57104
Actively Recruiting
103
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, United States, 57117-5134
Actively Recruiting
104
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin, United States, 54701
Actively Recruiting
105
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, United States, 54449
Actively Recruiting
106
Marshfield Medical Center - Minocqua
Minocqua, Wisconsin, United States, 54548
Actively Recruiting
107
Cancer Center of Western Wisconsin
New Richmond, Wisconsin, United States, 54017
Actively Recruiting
108
Marshfield Medical Center-Rice Lake
Rice Lake, Wisconsin, United States, 54868
Actively Recruiting
109
Marshfield Medical Center-River Region at Stevens Point
Stevens Point, Wisconsin, United States, 54482
Actively Recruiting
110
Marshfield Medical Center - Weston
Weston, Wisconsin, United States, 54476
Actively Recruiting
111
Billings Clinic-Cody
Cody, Wyoming, United States, 82414
Actively Recruiting
112
Welch Cancer Center
Sheridan, Wyoming, United States, 82801
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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