araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 58-year-old female with adenoid cystic carcinoma; genetic feature: KIT

Clinical trial: Boron Neutron Capture Therapy, Radiation Therapy, and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

Summary: RATIONALE: Boron neutron capture therapy and radiation therapy use high-energy x-rays and other types of radiation to kill tumor cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving boron neutron capture therapy followed by radiation therapy and temozolomide may kill more tumor cells.
  PURPOSE: This phase II trial is studying the side effects of giving boron neutron capture therapy together with radiation therapy and temozolomide in treating patients with newly diagnosed glioblastoma multiforme.

Detailed description: OBJECTIVES:
  -  Evaluate the overall survival of patients with newly diagnosed glioblastoma multiforme treated with boron neutron capture therapy, radiotherapy, and concurrent and adjuvant temozolomide.
  -  Evaluate tumor response in patients treated with this regimen.
  -  Evaluate the adverse effects of this regimen in these patients.
  OUTLINE: This is a multicenter study.
  Patients undergo boron neutron capture therapy followed by radiotherapy and concurrent and adjuvant oral temozolomide.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically confirmed glioblastoma multiforme
  -  Newly diagnosed disease
  -  Tumor located at a supratentorial hemisphere
  -  Deepest part of tumor < 6 cm from the scalp
  -  Bottom of the tumor > 6 cm from the scalp allowed provided air instillation into tumor-removed cavity is possible
  -  No cerebrospinal fluid dissemination
  PATIENT CHARACTERISTICS:
  -  Karnofsky performance status 70-100%
  -  Life expectancy > 3 months
  -  Leukocyte count ≥ 3,000/μL
  -  Platelet count ≥ 10.0 × 10^4/μL
  -  Hemoglobin ≥ 8.0 g/dL
  -  Serum creatinine ≤ 1.5 mg/dL
  -  ALT and AST ≤ 100 IU/L
  -  No phenylketonuria
  -  Not pregnant or nursing
  -  No NYHA class III-IV heart failure
  -  No patient whose participation in the present study is considered inappropriate by a Principal Investigator or Clinical Investigator
  PRIOR CONCURRENT THERAPY:
  -  No prior chemotherapy or radiotherapy

Relevance to patient case: not relevant
Patient case: 58-year-old female with adenoid cystic carcinoma; genetic feature: KIT

Clinical trial: Pharmacogenomic Study to Predict Neurotoxicity of Oxaliplatin

Summary: In order to explore genetic factors that may determine the neurotoxicity of oxaliplatin-based chemotherapy, germinal gene polymorphisms will be analyzed.

Detailed description: To investigate the impact of single nucleotide (SNP) polymorphism on the toxicity profile in colorectal cancer patients treated with FOLFOX chemotherapy, 10 cc of blood will be drawn in EDTA tube for extraction. DNA will be extracted from peripheral blood samples using DNA isolation kit, and SNP polymorphisms will be evaluated.

Eligibility: Inclusion Criteria:
  -  aged 18 or older
  -  curatively resected colon adenocarcinoma
  -  pathologically staged III
  -  adequate performance status
  -  adequate major organ functions
  -  to be treated with adjuvant FOLFOX chemotherapy
  -  written informed consent
  Exclusion Criteria:
  -  those who disagree the study

Relevance to patient case: not relevant
Patient case: 58-year-old female with adenoid cystic carcinoma; genetic feature: KIT

Clinical trial: MRI Mapping in Planning Radiation Therapy to the Base of Skull and Brain in Patients With Nonmetastatic Head and Neck Cancer

Summary: RATIONALE: Diagnostic procedures, such as specialized types of magnetic resonance imaging (MRI), may help in planning radiation therapy that does less damage to normal tissues.
  PURPOSE: This phase I trial is studying using functional MRI to see how well it works in planning radiation therapy in patients undergoing radiation therapy to the base of the skull and/or brain for nonmetastatic head and neck cancer.

Detailed description: OBJECTIVES:
  -  To determine the feasibility of applying established MRI techniques to map functional anatomic regions at potential risk in irradiated normal brain tissue of patients undergoing radiotherapy to the base of the skull and brain for head and neck neoplasms.
  -  To determine changes in cerebral blood flow and blood volume with perfusion MRI techniques in irradiated regions of the brain as a function of the radiation dose.
  OUTLINE: Patients undergo MRI perfusion imaging and functional (fMRI) (standard structural imaging sequences, diffusion tensor imaging, arterial spin labeled perfusion imaging at rest, blood oxygen level dependent, and dynamic susceptibility contrast perfusion weighted MRI) at baseline and 3 and 6 months after completion of radiotherapy. Patients may perform tasks for fMRI studies, including finger tapping, photic stimulation with a flashing light, solving math problems, comparing shapes, giving a speech, or listening to and reciting lists of words during fMRI image acquisition. Patients also undergo daily fractionated intensity-modulated radiotherapy.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically confirmed head and neck cancer that requires radiotherapy to the base of the skull
  -  No evidence of metastatic disease
  PATIENT CHARACTERISTICS:
  -  ECOG performance status 0-1
  -  Life expectancy ≥ 1 year
  -  Not pregnant
  -  Negative pregnancy test
  -  Able to undergo standard CT simulation and radiotherapy treatment planning and delivery, including the capacity to comply with standard immobilization devices to the head and neck for daily irradiation
  -  Able to undergo standard MRI and deemed capable of complying with the immobilization needs and tasks required for functional MRIs
  -  No claustrophobia
  -  No patients with pacemakers, metal fragments in the eye, or certain metallic implants
  PRIOR CONCURRENT THERAPY:
  -  Not specified

Relevance to patient case: not relevant
Patient case: 58-year-old female with adenoid cystic carcinoma; genetic feature: KIT

Clinical trial: Safety Study of PLX108-01 in Patients With Solid Tumors

Summary: PLX3397 is a selective inhibitor of Fms, Kit, and oncogenic Flt3 activity. The primary objective of this study is to evaluate the safety and pharmacokinetics of orally administered PLX3397 in patients with advanced, incurable, solid tumors in which these target kinases are linked to disease pathophysiology. The secondary objective is to measure the pharmacodynamic activity of PLX3397 via blood, plasma and urine biomarkers of Fms activity.


Eligibility: Inclusion Criteria:
  -  Age 18 and older
  -  Solid tumors refractory to standard therapy
  -  For the Extension cohorts, patients must have measurable disease by RECIST criteria and meet the following disease-specific criteria:
  -  For advanced or recurrent mucoepidermal carcinoma (MEC) of the salivary gland, patients must not be candidates for curative surgery or radiotherapy.
  -  For pigmented villo-nodular synovitis (PVNS), patients must have a histologically confirmed diagnosis of inoperable progressive or relapsing PVNS, or resectable tumor requesting mutilating surgery, as well as demonstrated progressive disease in the last 12 months.
  -  For gastrointestinal stromal tumors (GIST), patients must have failed previous therapy with imatinib and sunitinib. Patients with known PDGFR mutations are excluded, but mutation testing is not required for study entry.
  -  For anaplastic thyroid cancer (ATC), patients must have histologically or cytologically diagnosed advanced ATC.
  -  For metastatic solid tumors with documented malignant pleural and/or peritoneal effusions, patients must not be receiving specific therapy for the effusion or have an indwelling drain.
  -  ECOG performance status 0 or 1
  -  Life expectancy >= 3 months
  -  Adequate hepatic, renal, and bone marrow function
  Exclusion Criteria:
  -  Specific anti-cancer therapy within 3 weeks of study start
  -  Uncontrolled intercurrent illness
  -  Refractory nausea or vomiting, or malabsorption
  -  Mean QTc >= 450 msec (for males) or QTc >= 470 msec (for females)

Relevance to patient case: not relevant
Patient case: 58-year-old female with adenoid cystic carcinoma; genetic feature: KIT

Clinical trial: Genome Wide SNP Array-based Approach to Detect Micro-cytogenetic Lesions and KIT Mutation to Improve Treatment Outcomes in Patients With Core-binding Factor Positive Acute Myeloid Leukemia

Summary: Core binding factor (CBF) positive acute myeloid leukemia (AML) consist of 15% of patients in overall AML, expected to harbor a favorable prognosis. However, around a half of cases relapses. Accordingly, more sophisticated classification in CBF positive AMLs is essential to achieve further improvement in the treatment outcome. The current study is designed to evaluate CBF positive AML patients with genome-wide SNP array and KIT mutation study in CBF positive AML patients diagnosed at the Samsung Medical Center and Hwasun Chonnam National University Hospital, Korea between 1994 and 2008.
  1. Construction of the CBF positive AML patient cohort: clinical database establishment (including treatment outcomes and prognosis) and extraction/storage of tumor cell DNAs from marrow samples, then processing of Affymetrix SNP array 6.0.
  2. Construction of prognostic predictive model using pharmacogenomics with the results of genotypes and copy number variations (CNVs).
  3. Detection of hidden microscopic cytogenetic lesions with SNP array technique, and correlation with clinical outcomes in CBF positive AML.
  4. Detection of KIT, FLT3/ITD, and NPM1 gene mutation and its correlation with clinical outcomes in CBF positive AML.
  The current study attempts to analyze genetic data of core binding factor (CBF) positive acute myeloid leukemia (AML) using genome wide SNP array technique with tumor DNAs collected at the time of diagnosis.
  1. To detect microcytogenetic lesions and will analyze its prognostic significance
  2. To analyze genome-wide genotypes and copy number variations (CNVs) using pharmacogenetic approach and will construct a prognostic predictive model
  3. To detect KIT, FLT3/ITD and NPM1 mutation and evaluate its prognostic significance. The present study will establish individualized therapy for CBF positive AML, will provide a basis for molecular marker guided clinical trial in CBF positive AML.


Eligibility: Inclusion Criteria:
  -  patients with core binding factor positive acute myeloid leukemia
  -  18 years or older
  -  patients were treated with standard chemotherapy
  -  patients with available medical record and stored bone marrow specimen at time of diagnosis
  Exclusion Criteria:
  -  no definive criteria

Relevance to patient case: not relevant
Patient case: 58-year-old female with adenoid cystic carcinoma; genetic feature: KIT

Clinical trial: Study of Nilotinib in Metastatic Melanoma With KIT Aberrations

Summary: Major response was observed to imatinib mesylate in KIT-mutated metastatic rectal melanoma (Hodi FS et al, J Clin Oncol 26:2046-2051, 2008). In the ASCO annual meeting in 2009ar, KIT mutations were reported to be present in 23% of acral and 15.2% of mucosal melanomas (Heinrich MC et al, J Clin Oncol 26:2008 abstr 9016). Nilotinib is a novel tyrosine kinase inhibitor (TKI) targeting KIT, PDGFR, and Bcr-Abl and inhibiting the proliferating of both imatinib-sensitive and imatinib-resistant cells in vitro. Phase I study of nilotinib alone and in combination with imatinib in patients with imatinib-resistant gastrointestinal stromal tumors (GIST) demonstrated significant activity (72% stable disease for nilotinib alone and 56% for nilotinib/imatinib combination) (Blay JY et al, J Clin Oncol 26:2008, abstr 10553).
  Thus, we propose to conduct a phase II study of nilotinib in metastatic melanoma with KIT mutations.


Eligibility: Inclusion Criteria:
  1. Histologically or cytologically proven melanoma with stage IV or unresectable stage III disease
  2. Documented KIT aberration
  3. Adequate organ function as defined by the following criteria:
  -  Serum aspartate transaminase (AST); serum glutamic oxaloacetic transaminase (SGOT)) and serum alanine transaminase (ALT); serum glutamic pyruvic transaminase (SGPT)) ≤ 2.5 x local laboratory upper limit of normal (ULN), or AST and ALT less than or equal to 5 x ULN if liver function abnormalities are due to underlying malignancy
  -  Total serum bilirubin ≤ 1.5 x ULN
  -  Absolute neutrophil count (ANC) ≥ 1500/µL
  -  Platelets ≥ 100,000/µL
  -  Hemoglobin ≥ 9.0 g/dL (may be transfused or erythropoietin treated)
  -  Serum calcium ≤ 12.0 mg/dL
  -  Serum creatinine ≤ 1.5 x ULN
  4. Patients with CNS metastasis must have stable neurologic function without evidence of CNS progression within 8 weeks
  5. May have previous adjuvant therapy with interferon, vaccines or therapy with IL-2, chemotherapy
  6. At least one measurable lesion by RECIST criteria
  7. ECOG PS 0-2
  Exclusion Criteria:
  1. Major surgery or radiation therapy within 4 weeks of starting the study treatment.
  2. History of or known carcinomatous meningitis, or evidence of symptomatic leptomeningeal disease on screening CT or MRI scan.
  3. Ongoing cardiac dysrhythmias of NCI CTCAE grade ≥ 2.
  4. QTc > 470 msec on baseline EKG.
  5. Pregnancy or breastfeeding.

Relevance to patient case: not relevant
Patient case: 58-year-old female with adenoid cystic carcinoma; genetic feature: KIT

Clinical trial: Comparison of Predictive Factors Related to Coronary Artery Disease Among Different Menopausal Status and Effect of a Life Style Management Program on Risk Factors Modification Among Middle-aged Women

Summary: In Taiwan, heart disease and cerebrovascular disease ranked the second and third of ten leading causes of death in female in 2007; half of these deaths is due to coronary artery disease (CAD). Postmenopausal status is an independent risk factor for CAD. Early assessment and proper management of risk factors may reduce the prevalence rate of CAD. In the past decade, despite increased attention to CAD in women, most studies focused on certain menopausal status instead of all phases of menopause or on risk factors limited to related metabolic syndrome. Because the prevalence of risk factors related to CAD is influenced by various physiological and lifestyle status in different menopausal statuses, the purpose of this study, at the first stage, is to explore respectively the risk factors of CAD among middle-aged women in three menopausal statuses. At the second stage, the influence of a lifestyle management program on risk factors modification among pre-menopausal women is examined in this study.


Eligibility: Inclusion Criteria:
  -  diagnosis of CAD by coroangiography
  -  LVEF >30%
  Exclusion Criteria:
  -  impairment of physical activity
  -  history of psychiatric disorder, vital arrhythmia

Relevance to patient case: not relevant
Patient case: 58-year-old female with adenoid cystic carcinoma; genetic feature: KIT

Clinical trial: CO(Mbined Therapy of Malignant) S(Alivary Gland tu)M(Ours With)I(MRT and) c(Arbon Ions): COSMIC

Summary: The COSMIC trial is a prospective, mono-centric, phase II trial evaluating toxicity and efficacy in the combined treatment with intensity-modulated radiation therapy (IMRT) and carbon ion (C12) boost. Primary endpoint is mucositis ≥ CTC°3, secondary endpoints are local control, disease-free survival, and toxicity. Planned accrual of the trial includes 54 patients with histologically proved (≥R1-resected, inoperable or Pn+) salivary gland malignancies. Treatment consists of 24 GyE carbon ions (8 fractions) and 50 Gy IMRT (2.0 Gy/ fraction).

Detailed description: Local control in malignant salivary gland tumours is dose dependent. High local control rates in adenoid cystic carcinomas could be achieved by highly conformal radiotherapy techniques and particle (neutron/ carbon ion) therapy. Considering high doses are needed to achieve local control, all malignant salivary gland tumours probably profit from the use of particle therapy, which in case of carbon ion treatment, has been shown to be accompanied by only mild side-effects.
  Methods/ design:
  The COSMIC trial is a prospective, mono-centric, phase II trial evaluating toxicity in the combined treatment with intensity-modulated radiation therapy (IMRT) and carbon ion (C12) boost in 54 patients with histologically proved (≥R1-resected, inoperable or Pn+) salivary gland malignancies. Patients receive 24 GyE carbon ions (8 fractions) and IMRT (2.0 Gy/ fraction).
  Study objectives:
  Incidence of mucositis ≥ CTC°3 will be assessed as the primary endpoint of the trial, local control, disease-free survival, toxicity (incl. mucositis CTC °I-II and late toxicity at 3 years post RT)

Eligibility: Inclusion Criteria:
  -  Histologically confirmed or surgically removed malignant tumour of the salivary glands (head and neck)
  -  Inoperable tumour
  -  G2/3
  -  Macroscopic or microscopic residual tumour (R2/ R1) or
  -  ≥T3/T4 or
  -  perineural invasion (Pn+)
  -  written informed consent
  -  pts aged 18 - 80 years
  -  effective contraception for pts in childbearing age (<12 months post beginning of menopause)
  Exclusion Criteria:
  -  Prior radio- or chemotherapy for tumours of the head and neck
  -  Other previous malignancy within the past 5 years except prior, adequately treated basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix
  -  Significant neurological or psychiatric condition including dementia or seizures or other serious medical condition prohibiting the patient's participation in the trial by judgement of the investigators
  -  Legal incapacity or limited legal capacity
  -  Positive serum/ urine beta-HCG/ pregnancy
  -  Drug abuse

Relevance to patient case: not relevant
Patient case: 58-year-old female with adenoid cystic carcinoma; genetic feature: KIT

Clinical trial: Esophagoscopy in Evaluating Treatment in Patients With Stage I-IV Head and Neck Cancer Who Are Undergoing Radiation Therapy and/or Chemotherapy

Summary: Brief Summary:
  RATIONALE: Comparing results of diagnostic procedures, such as esophagoscopy, done before and after radiation therapy and/or chemotherapy may help doctors predict a patient's response to treatment and help plan the best treatment.
  PURPOSE: This clinical trial is studying esophagoscopy in evaluating treatment in patients with stage I-IV head and neck cancer who are undergoing radiation therapy and/or chemotherapy.

Detailed description: OBJECTIVES:
  I. To assess the prevalence of esophageal pathology (any esophageal abnormality, specifically: esophagitis, stricture/web, infections, neoplasms) as identified by esophagoscopy in patients with HNCA before and 3 months following primary radiation and/or chemotherapy.
  II. To assess the changes in self-reported dysphagia symptoms as measured by the Eating Assessment Tool.
  OUTLINE:
  Patients undergo transnasal esophagoscopy at baseline and 3 months following completion of radiation therapy and/or chemotherapy.

Eligibility: Inclusion
  -  Written informed consent must be obtained from all participants prior to beginning therapy; participants should have the ability to understand and be willing to sign a written informed consent document
  -  Primary diagnosis of head and neck carcinoma (oral, hypopharyngeal, laryngeal)
  -  Stage I-IV, undergoing treatment with radiation therapy +/- chemotherapy
  Exclusion
  -  Medical history of esophageal dysfunction
  -  Pregnant women are not excluded from participation

Relevance to patient case: not relevant
Patient case: 58-year-old female with adenoid cystic carcinoma; genetic feature: KIT

Clinical trial: A Retrospective Study of C-kit Mutation Status in Asian Patients With Advanced Gastro-intestinal Stromal Tumors (GIST) Treated With Imatinib.

Summary: Imatinib is the current standard treatment for advanced GIST. Previous studies have shown that GIST genotype was associated with treatment outcomes with exon 11 having superior outcome compared with exon 9 or WT.10, 11 In patients with exon 9 kit mutation, the response rate was higher at when imatinib was given at 800mg daily compared with the standard dose of 400mg daily. Although the data linking tyrosine kinase mutation status and imatinib response in metastatic GISTs is intriguing, more information is needed before mutation testing is adopted as part of the routine analysis of high-risk or overtly malignant KIT-expressing GISTs.25 Despite the fact that exon 9 mutations are associated with a lower response rate, overall survival does not appear to be better with high-dose therapy. The investigators propose to conduct a retrospective analysis of mutational analysis on patients with GIST and determine the relationship between patient response and imatinib dose.


Eligibility: Inclusion Criteria:
  1. Histologic diagnosis of advanced stage or metastatic GIST
  2. Asian patient (as defined by the investigator)
  3. First line treatment with imatinib
  4. Availability of tumor samples for kit mutation analysis
  5. Availability of tumor response rate and or time to progression data
  Exclusion Criteria:

Relevance to patient case: not relevant
Patient case: 58-year-old female with adenoid cystic carcinoma; genetic feature: KIT

Clinical trial: Transoral Robotic Surgery in Treating Patients With Benign or Stage I-IV Head and Neck Cancer

Summary: RATIONALE: Transoral robotic surgery (TORS) is a less invasive type of surgery for head and neck cancer and may have fewer side effects and improve recovery. PURPOSE: This clinical trial studies how transoral robotic surgery works in treating patients with benign or stage I-IV head and neck cancer.

Detailed description: PRIMARY OBJECTIVES: To conduct a pilot study at City of Hope (COH) which assesses the feasibility and safety of TORS (Transoral robotic surgery), including: total operative time, blood loss, hospitalization time, need to convert to an open procedure, intra-operative as well as post-operative complications. SECONDARY OBJECTIVES: I. To collect data on oncologic outcomes, disease free survival, local control rate and overall survival. II. To collect normative data regarding objective functional outcomes (FO) which may impact quality of life in patients undergoing TORS, including need for adjunctive procedures, such as gastrostomy tube placement and tracheostomy placement, and with regards to speech, swallowing function and pain, using patient-report outcomes instruments. OUTLINE: Patients undergo transoral robotic microsurgery. After completion of study treatment, patients are followed up periodically for 5 years.

Eligibility: Inclusion Criteria:
  -  Patients clinical, radiologic or pathologic evidence of a benign or malignant tumor in the oral cavity, oropharynx, nasopharynx, hypopharynx, larynx, retropharynx or parapharyngeal space
  -  Surgical access is amenable to treatment with conventional transoral surgical procedures
  -  ASA (American Society of Anesthesiologists) performance status (PS) of 1-4 or ECOG (Eastern Cooperative Oncology Group) PS 0-3, thereby including a population that stands to gain the most from a minimally invasive surgical approach
  -  Patients should have no serious acute infection
  -  Patients must sign a study-specific informed consent form
  Exclusion Criteria:
  -  Evidence of distant metastases (below the clavicle) by clinical or radiographic measures
  -  ASA score > 4; ECOG PS score > 3
  -  Pregnancy (during first or 3rd trimester - due to risks of anesthesia)
  -  The presence of medical conditions which contraindicate general anesthesia
  -  Unexplained fever or untreated, active infection
  -  Inability to obtain exposure to allow performance of the planned transoral surgical procedure
  -  Proposed surgical site with history of prior treatment: radiation
  -  Tumor adherent to carotid artery or jugular vein
  -  Fixation to pre-vertebral tumor
  -  Mandibular invasion

Relevance to patient case: not relevant