NEO- and Adjuvant Targeted Therapy in Braf-mutated Anaplastic Cancer of the Thyroid (NEO-ATACT Study)...
Anaplastic Thyroid CancerAnaplastic 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.
Thyroxine Replacement Therapy After Lobectomy for Low-risk Papillary Thyroid Carcinoma
Thyroid CancerSurgery1 morePapillary thyroid carcinoma (PTC) is the most common thyroid cancer and has a good prognosis.According to the 2015 American thyroid association (ATA) guidelines, no gross extrathyroidal extension and the number of pathological lymph node micrometastases (<0.2cm) ≤5 were defined as the low recurrence risk group. After total thyroidectomy and radioiodine treatment, the probability of disease-free status (irritant Tg<1ng/ml, no evidence of other disease recurrence) is about 78%-91%, and the probability of structural recurrence is about 1%-10%. In recent years, due to the further understanding of PTC, surgeons tend to become more conservative in treatment, such as active observation or reducing the extent of surgery. The indication for lobectomy has been extended to tumors <4cm without extrathyroidal extension and clinical lymph node metastasis. For patients treated with lobectomy, current guidelines recommend that Thyroid Stimulating Hormone (TSH) be controlled at 0.5-2 mU/L, but evidence on the prognostic benefits of this TSH inhibition range is lacking.In recent years, a number of studies have suggested that if postoperative TSH in low-risk patients after lobectomy is acceptable within the reference range, it means that a considerable number of patients have a high probability of not receiving thyroxine replacement therapy after surgery, which can significantly improve their quality of life.A previous retrospective study from our institute showed no significant association between TSH levels after lobectomy and prognosis.The aim of this study was to evaluate the benefits and risks of postoperative TSH levels within the reference range (0.4-5 mU/L) in patients with low-risk papillary thyroid cancer who underwent lobectomy.In order to improve the effect of longer recurrence and death time of PTC, the investigators also performed postoperative thyroglobulin and its antibody for short-term treatment response evaluation.
Targeted Alpha Therapy Using Astatine (At-211) Against Differentiated Thyroid Cancer
Thyroid CancerSingle intravenous administration of TAH-1005 is performed in patients with differentiated thyroid cancer (papillary cancer, follicular cancer) who cannot obtain therapeutic effect with standard treatment or who have difficulty in implementing and continuing standard treatment. The safety, pharmacokinetics, absorbed dose, and efficacy will be evaluated to determine the recommended dose for Phase II clinical trial.
I-124 PET/CT Based Remnant Radioiodine Ablation Decision Concept in Differentiated Thyroid Cancer...
Differentiated Thyroid CarcinomaThyroid nodules are a common clinical problem. Epidemiologic studies have shown the prevalence of palpable thyroid nodules to be approximately 5% in women and 1% in men living in iodine-sufficient parts of the world and up to 30% in iodine deficient regions, such as Germany. The clinical importance of thyroid nodules rests with the need to exclude thyroid cancer which occurs in 5-15%. Differentiated thyroid cancer (DTC), which includes papillary and follicular cancer, comprises the vast majority (90%) of all thyroid cancers. In Germany, approximately 7,000 new cases will be diagnosed in 2011. The yearly incidence has increased from 3.6 per 100,000 in 1973 to 8.7 per 100,000 in 2002, and this trend appears to be continuing. Recurrence-free survival is generally excellent and depends on the risk group. The role of postoperative remnant radioiodine ablation (RRIA) as the most serious question regarding the initial management of DTC still needs to be resolved even after decades of radioiodine use. American Thyroid Association directions for future research addressing these questions include: Better understanding of the long-term risks of radioiodine use; Improved risk stratification; Randomized controlled trials are still missing in which RRIA has proven its worth as a safe and very effective treatment that results in an improved life expectancy and a reduced recurrence rate. Many observational studies lack sufficiently high evidence. Evidence grade is rated mainly on "expert level", based on non-randomized retrospective observation studies. Although RRIA in Europe is established as adjuvant standard treatment for all patients with DTC, except those with stage T1a, it remains to be shown throughout if it is beneficial for low risk and medium risk patients without metastases (M0), also known as stage I patients according to UICC/AJCC classification, accounting for 40-90% of all patients. Blood doses due to cumulative radioiodine therapy may well exceed 2 Gy, and RRIA induces an average blood dose of 0.28 Gy to the entire body. Risks as estimated from that dose are not insignificant. The question is whether or not the condition after remnant ablation justifies such an increased risk of a secondary malignancy. The probability of causation for a pharyngeal or breast tumour can well exceed the margin of a 50% after being exposed to RRIA or consecutive I-131 diagnostic imaging to explore measureable Tg levels. Even though radioiodine therapy can benefit some patients with advanced thyroid carcinoma, it is still unknown whether the risks of RRIA outweigh any discernable benefit. Undoubtedly, quality of life may be affected by adjuvant use of I-131. Study Hypothesis: The I-124 study arm may have considerable benefits for the patient included in the study. These include enhanced tumour and risk stratification, avoidance of unnecessary I-131 exposure in 30-89 percent of patients who were classified with "low risk" tumour (MACIS or AMES scoring) or "stage I disease" (UICC-AJCC TNM staging system), and, improved quality of life at the same or better morbidity and mortality rates in the I-124 arm. Environmental and hospital staff related benefits include prevention or saving of I-131 exposure. This study is designed to compare effectiveness of treatments following and evaluating guideline recommendations in two assignment arms.
A Multicenter Trial of Radiofrequency Ablation vs. Surgery as Treatment of Papillary Thyroid Microcarcinoma....
Papillary Thyroid MicrocarcinomaThe treatment of Papillary Thyroid Microcarcinoma (PTMC) nowadays varies among physicians, surgeons and radiologist. The recently published articles show that the prognosis of PTMC by different means of treatment strategies tends to be good. But multicentered, randomized, parallel and prospective study is rare. RFA is the abbreviation of "Radiofrequency Ablation", which tends to be an alternative strategy except conventional surgery. The investigator aims to confirm whether RFA for treating PTMC braces same effectiveness and prognosis comparing with conventional surgery. Besides, this trial also investigates the safety, economy and psychological quality under different treatments.
A Phase I/II Study of Regorafenib Plus Avelumab in Solid Tumors
Colorectal Cancer Not MSI-H or MMR-deficientGIST14 moreAssessment of the efficacy and safety of Regorafenib and Avelumab in patients with advanced or metastatic solid tumors (ten cohorts), once the Recommanded Phase II Dose (RP2D) has been determined (phase I trial). Assessement of the efficacy and safety of a low-dose of regorafenib (80mg/day) with avelumab in patients with advanced or metastatic colorectal tumors.
Study of Aerosol Gemcitabine in Patients With Solid Tumors and Pulmonary Metastases
Malignant Neoplasm of Bone and Articular CartilageMalignant Neoplasms of Female Genital Organs8 moreAny time the words "you," "your," "I," or "me" appear, it is meant to apply to the potential participant. The goal of this clinical research study is to find the highest tolerable dose of gemcitabine that can be given by inhalation (breathing it as a mist) to patients with solid tumors that have spread to the lungs from other parts of the body. The safety and side effects of this drug will also be studied. This is an investigational study. Gemcitabine is FDA approved and commercially available for the treatment of pancreatic and lung cancer, and other solid tumors. Its administration by inhalation is investigational. The study doctor can explain how the study drug is designed to work. Up to 44 participants will be enrolled in this study. All will take part at MD Anderson.
Pembrolizumab With Chemotherapy for Poorly Chemo-responsive Thyroid and Salivary Gland Tumors
Thyroid CancerSalivary Gland CancerPhase II, 2-cohort, single arm trial treated with the combination of the following two agents: Pembrolizumab (MK3475) 200mg, every three weeks, iv Docetaxel 75mg/m2, every three weeks, iv
Donor Natural Killer Cells, Cyclophosphamide, and Etoposide in Treating Children and Young Adults...
Recurrent Cutaneous MelanomaRecurrent Lip and Oral Cavity Carcinoma26 moreThis phase I trial studies the side effects and best dose of cord blood-derived expanded allogeneic natural killer cells (donor natural killer [NK] cells) and how well they work when given together with cyclophosphamide and etoposide in treating children and young adults with solid tumors that have come back (relapsed) or that do not respond to treatment (refractory). NK cells, white blood cells important to the immune system, are donated/collected from cord blood collected at birth from healthy babies and grown in the lab. Drugs used in chemotherapy, such as cyclophosphamide and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving NK cells together with cyclophosphamide and etoposide may work better in treating children and young adults with solid tumors.
Durvalumab Plus Tremelimumab for the Treatment of Patients With Progressive, Refractory Advanced...
Metastatic Thyroid Papillary CarcinomaMetastatic Thyroid Follicular Carcinoma1 moreThis is a prospective, multi-centre, open label, stratified, exploratory phase II study evaluating the efficacy and safety of durvalumab plus tremelimumab in different cohorts of patients with thyroid cancers.