This trial studies how well dabrafenib, trametinib, and intensity modulated radiation therapy (IMRT) work together in treating patients with BRAF mutated anaplastic thyroid cancer. Dabrafenib and trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy beams to kill tumor cells and shrink tumors. Giving dabrafenib, trametinib, and IMRT together may kill more tumor cells.
Name: Dabrafenib
Name: Intensity-Modulated Radiation Therapy
Name: Trametinib
Description: Will be defined as the proportion of patients who have a partial response (PR), or complete response (CR) within the first 4 weeks of IMRT. Complete response (CR) and partial response (PR) will be defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Will be calculated with the exact binomial 95% confidence intervals.
Measure: Objective response rate Time: 1 yearDescription: Will be evaluated by RECIST criteria for disease limited to the radiation field (neck) following the first set of scans after completion of IMRT. Estimated by Kaplan-Meier method.
Measure: Time to progression for local disease recurrence Time: 1 yearDescription: Estimated by Kaplan-Meier method.
Measure: Overall survival Time: From the start date of the treatment to the date of death, assessed up to 1 yearDescription: Estimated by Kaplan-Meier method.
Measure: Progression free survival Time: Time from start of treatment to time of progression or death, whichever occurs first, assessed up to 1 yearAllocation: N/A
Single Group Assignment
There are 2 SNPs
- Presence of BRAF mutation (V600E or V600K) in tumor tissue. --- V600E ---
- Presence of BRAF mutation (V600E or V600K) in tumor tissue. --- V600E --- --- V600K ---
BRAF NP_004324.2:p.V600E BRAF V600K Mutation Present Thyroid Gland Anaplastic Carcinoma Thyroid Neoplasms Thyroid Carcinoma, Anaplastic Carcinoma Thyroid Diseases PRIMARY OBJECTIVES: I. To assess the safety and tolerability (maximum tolerated dose [MTD]) of concurrent intensity modulated radiation therapy (IMRT) and BRAF-MEK inhibitors dabrafenib and trametinib in patients with BRAF-mutated anaplastic thyroid cancer. --- V600K ---