Clinical Trials Logo

Clinical Trial Summary

Anaplastic thyroid cancer (ATC) is an almost invariable lethal cancer in humans. Most patients present with a rapid progressive mass in the neck with progressive complaints like dyspnoea, dysphagia or pain. The risk of suffocation is the main reason for rapid surgical intervention, but we know from literature that an oncological resection with clear margins is seldomly achieved. Some patients deteriorate that fast after surgery that radiation therapy and/or chemotherapy is not feasible anymore. Patients with BRAF-mutated ATC already have shown to benefit from targeted BRAF/MEK inhibition. This study aims to increase the number of patients that undergo a successful R0 tumor resection after neo-adjuvant BRAF/MEK inhibitor treatment.


Clinical Trial Description

Unmet need ATC is a very serious condition and is, apart from a few exclusive cases, always lethal. Many patients suffer uncontrollable loco-regional disease with even so uncontrollable complaints of airway obstruction, oesophagus obstruction, pain and neck movement impairment. One of the only shown beneficial treatment is complete surgical resection with clear surgical margins combined with radiotherapy and systemic treatment. However, in less than 10-15% of the patients the pathologist reports clear surgical margins. Thereby it is noticeable that surgery often results in serious morbidity, due to an esophagectomy, laryngectomy or trachea resection all accompanied by an extensive reconstruction. All of these come with serious morbidity and seldomly lead to clear margins and better outcome. Proposed solution A single center, phase II study for the evaluation of safety and efficacy of neo-adjuvant and adjuvant dabrafenib/trametinib treatment in BRAF mutated ATC patients. By introducing neo-adjuvant treatment the hypothesis is that better selection is done for patients who are eligible for complete surgery and that surgery results more often in clear surgical margins after neo-adjuvant treatment. Second benefit of treating patients with combined loco-regional and systemic agents before surgery is that micro/macrometastases (being there in at least 30% of the patients at diagnosis) are already being treated directly after diagnosis. Lastly, adjuvant treatment with dabrafenib/trametinib will hopefully result in reduction of local and distant recurrences after surgery. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06079333
Study type Interventional
Source Leiden University Medical Center
Contact Ellen Kapiteijn, MD, PhD
Phone 0031-71-5263486
Email h.w.kapiteijn@lumc.nl
Status Recruiting
Phase Phase 2
Start date January 1, 2023
Completion date January 1, 2028

See also
  Status Clinical Trial Phase
Recruiting NCT04420754 - Study of AIC100 CAR T Cells in Relapsed/Refractory Thyroid Cancer Phase 1
Completed NCT02152137 - Inolitazone Dihydrochloride and Paclitaxel in Treating Patients With Advanced Anaplastic Thyroid Cancer Phase 2
Active, not recruiting NCT04552769 - Abemaciclib in Metastatic or Locally Advanced Anaplastic/Undifferentiated Thyroid Cancer Phase 2
Active, not recruiting NCT04400474 - Trial of Cabozantinib Plus Atezolizumab in Advanced and Progressive Neoplasms of the Endocrine System. The CABATEN Study Phase 2
Completed NCT02688608 - Pembrolizumab in Anaplastic/Undifferentiated Thyroid Cancer Phase 2
Terminated NCT00095693 - Sorafenib Tosylate in Treating Patients With Locally Advanced, Metastatic, or Locally Recurrent Thyroid Cancer Phase 2
Active, not recruiting NCT01240590 - A Phase I/II Trial of Crolibulin (EPC2407) Plus Cisplatin in Adults With Solid Tumors With a Focus on Anaplastic Thyroid Cancer (ATC) Phase 1/Phase 2
Not yet recruiting NCT05819593 - Evaluating Trends in Anaplastic Thyroid Cancer Patients' Clinical Study Experiences
Active, not recruiting NCT04579757 - Surufatinib in Combination With Tislelizumab in Subjects With Advanced Solid Tumors Phase 1/Phase 2
Recruiting NCT06374602 - Efficacy of Pembrolizumab and Lenvatinib in Patients With Anaplastic Thyroid Cancer Phase 2
Recruiting NCT06362694 - Study of the Rechallenge Concept in Patients With BRAF-positive Anaplastic Thyroid Cancer After Progression on Anti-BRAF Therapy Phase 2
Withdrawn NCT01701349 - Fosbretabulin or Placebo in Combination With Carboplatin/Paclitaxel in Anaplastic Thyroid Cancer Phase 3
Active, not recruiting NCT03085056 - Trametinib in Combination With Paclitaxel in the Treatment of Anaplastic Thyroid Cancer Early Phase 1
Recruiting NCT01774279 - interNational Anaplastic Thyroid Cancer Tissue Bank and Database (iNATT)
Terminated NCT00126568 - Sorafenib in Treating Patients With Advanced Anaplastic Thyroid Cancer Phase 2
Completed NCT02244463 - A Phase I/II Study of MLN0128 in Metastatic Anaplastic Thyroid Cancer and Incurably Poorly Differentiated or Radioidodine Refractory Differentiated Thyroid Cancer Phase 1/Phase 2
Active, not recruiting NCT05696548 - Nivolumab Plus Lenvatinib Against Anaplastic Thyroid Cancer (NAVIGATION) Phase 2
Terminated NCT00603941 - A Phase 1/2 Study of CS7017, an Oral PPARĪ³ Agonist, in Combination With Paclitaxel Phase 1/Phase 2
Completed NCT00280852 - Review of Multimodality Management of Anaplastic Thyroid Cancer N/A
Recruiting NCT04238624 - Study of Cemiplimab Combined With Dabrafenib and Trametinib in People With Anaplastic Thyroid Cancer Phase 2