araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 67-year-old male with esophageal cancer; genetic feature: EGFR

Clinical trial: Nimotuzumab in Combination With Radiotherapy for Esophageal Cancer

Summary: Nimotuzumab (hR3) is an IgG1 humanized monoclonal antibody that recognized an epitope located in the extra cellular domain of the human epidermal growth factor receptor (EGFR). Clinical efficacy has been shown in adult with head and neck cancer. The phase II study assessed the efficacy and safety of the combination of Nimotuzumab administered concomitantly with radiotherapy in patients with esophageal cancer tumours.

Detailed description: Clinical efficacy has been shown in adult with head and neck cancer. The phase II study assessed the efficacy and safety of the combination of Nimotuzumab administered concomitantly with radiotherapy in patients with esophageal cancer tumours.

Eligibility: Inclusion Criteria:
  1. pathologically or cytology diagnosed phase II-III esophageal carcinoma or IV thoracic segments carcinoma with the supraclavicular lymph nodes metastasis.
  2. with the measureable lesion of the newly diagnosed the esophageal carcinoma.
  3. age 18-75 years old
  4. ECOG≤2
  5. Expect survival date ≥3 months
  6. without serious diseases of important organs
  7. signature in the inform consent.
  Exclusion Criteria:
  1. pregnant or breast-feeding women or using a prohibited contraceptive method.
  2. with psychiatric diseases.
  3. with serious diseases or uncontrolled infection.
  4. with history of other tumors.
  5. participation other clinical trials within 1 month prior to inclusion in the trial.
  6. not the first antitumor treatment .

Relevance to patient case: definitely relevant
Patient case: 67-year-old male with esophageal cancer; genetic feature: EGFR

Clinical trial: Different Cycles of Capecitabine Usage in Esophageal Cancer Concurrent Chemoradiotherapy

Summary: Definitive chemoradiotherapy with cisplatin with cisplatin plus 5-fluorouracil is the standard in Western countries in esophagus cancer.But in China because of its toxic reaction, most of patients stop the halfway.Because low toxicity, Capecitabine is widely used in the chemotherapy of esophageal cancer.
  The purpose of this experiment was to study the different cycle on capecitabine with chemotherapy for esophageal cancer chemoradiation effect.We are prepared to within 2 years study recruited 200 patients with esophageal cancer.The primary endpoint is overall survival and the secondary endpoints include progression-free survival, response rate,pathologic complete response rate and adverse events.

Detailed description: We recruited the patients who were pathologically confirmed with esophageal squamous cell carcinoma from the Oct 2014. The the patients was divided into two groups. Group 1: Capecitabine + chemoradiation, radiation at the end of the stop using capecitabine. Group 2: Capecitabine + chemoradiation, at the end of the radiotherapy with capecitabine consolidating treatment for 5 weeks.

Eligibility: Inclusion Criteria:
  -  age 45-75years old
  -  Histologically proven squamous cell carcinoma of the esophagus
  -  the tumor was in T2-4N0-2M0
  -  The patients have not received the surgery or chemo-radiotherapy.
  -  Hb≥80g/L, absolute neutrophil count ≥1.5×109/L, Plt≥90×109/L,
  -  ALT、AST≤2.5*N,Cr≤1.5*N.
  -  performance status score 0-2
  Exclusion Criteria:
  -  pregnant, lactating women
  -  Oxaliplatin or fluorouracil Allergy or metabolic disorders
  -  Radiotherapy contraindications
  -  History of organ transplantation
  -  Brain metastasis
  -  The peripheral nervous system disorders
  -  Severe infection
  -  Oral capecitabine who have difficulty with,such as dysphagia,The activities of digestive ulcer, Gastrointestinal bleeding
  -  Severe chronic diseases, such as, hepatopathy, nephropathy, respiratory disease,high blood pressure, diabetes.
  -  Other malignant tumor in recent 5 years.

Relevance to patient case: not relevant
Patient case: 67-year-old male with esophageal cancer; genetic feature: EGFR

Clinical trial: "Acetic Acid Chromoendoscopy in Barrett's Esophagus Surveillance

Summary: Neoplasia in Barrett's esophagus could be missed during routine random biopsies. We propose a study using chromoendoscopy with Acetic Acid to increase the yield of biopsies in detecting neoplasia.

Detailed description: Neoplasia in Barrett's esophagus is often focal and can be missed by nontargeted biopsies alone. In recent years, various advanced endoscopic techniques have been utilized, but with varying success rates. Narrow-band imaging, trimodal imaging, spectral imaging and i-scan are technologies that are manufacturer dependent with limited varying success rates and have financial implications. At our institution, narrow band imaging is routinely utilized as a diagnostic tool for detecting Barrett's esophagus. Acetic acid is a commonly available dye that has been used in the detection of neoplasia in Barrett's esophagus.
  This study is aimed to prove the effectiveness of acetic acid chromoendoscopy in our Barrett's esophagus surveillance population. The goal is to compare the neoplasia yield of acetic acid chromoendoscopy with that of standardized random biopsy protocol. The sensitivity and specificity for neoplasia detection by these two methods will also be analyzed.
  Investigators plan to conduct this prospective randomized study for a period of one and a half years (beginning August 1, 2015, ending February 29, 2016). Based on data from 2014, we anticipate to enroll approximately 185 patients. All gastroenterologists (with privileges at Doctors Hospital at Renaissance) will participate in this study. Patients will be randomized to either acetic acid chromoendoscopy or current standard of care (standardized random biopsy protocol utilizing narrow band imaging). Random biopsies from both protocols and targeted biopsies (if identified) will be obtained and submitted to pathology department. These will be reviewed independently by two pathologists. Any discordant results will be reviewed by an outside expert pathologist. Statistical data analysis will be performed utilizing Datadesk XL software.

Eligibility: Inclusion Criteria:
  -  Patients 18 years and older
  -  Previous diagnosis of Barrett's esophagus, confirmed by pathology.
  Exclusion Criteria:
  -  Patients diagnosed with any level of dysplasia on previous esophageal biopsies.
  -  Patients who had esophageal therapy with Halo radiofrequency ablation in the past, or esophagectomy.
  -  History of allergy to Acetic Acid
  -  History of esophageal dysplasia or cancer
  -  Esophageal ulcerations
  -  Esophageal Candida
  -  Esophageal Varices
  -  Patients with active esophagitis
  -  Patients who cannot provide a valid consent
  -  Patients who are currently pregnant

Relevance to patient case: not relevant
Patient case: 67-year-old male with esophageal cancer; genetic feature: EGFR

Clinical trial: A Retrospective Study About Treatment Strategy After First/Second Line EGFR-TKI Failure

Summary: This is a multi-center retrospective study, designing to access the best treatment strategy in non-small cell lung cancer (NSCLC) patients harboring EGFR mutant type after first/second line EGFR-TKI failure. The study end point is Progression Free Survival 2 (PFS2), which is defined as the time period from Progression Disease 1(PD1) to Progression Disease 2(PD2). PD1 is defined as the first tumor progression time from taking EGFR-TKI evaluated by Recist 1.1 criterion, and PD2 as the second tumor progression time after EGFR-TKI failure no matter what second/third line treatment was, PD2 is also evaluated by Recist 1.1 criterion.


Eligibility: Inclusion Criteria:
  -  Patients who was confirmed stage IV (according to International Association for the Study of Lung Cancer（IASLC） TNM staging, 2009) non-small cell lung cancer (NSCLC) by histology or cytology between year 2009 to 2013, harboring EGFR mutant type (19 and/or 21 exon mutation).
  -  Appraisable disease, that is there must be at least one lesion with the longest diameter>10mm according to Recist 1.1 criterion (by contrast CT).
  -  Patients who take EGFR-TKI as first/second line therapy.
  Exclusion Criteria:
  -  Patients who has taken EGFR-TKI before.
  -  Patients who take EGFR-TKI as third or more line.
  -  Patients who take EGFR-TKI concurrent with chemotherapy or other anti-tumor drug.
  -  The evaluated lesions has treated with radiotherapy before or concurrent with EGFR-TKI.
  -  Patients whose EGFR expression is positive by immunochemical and/or EGFR amplification is positive by Fluorescence In Situ Hybridization(FISH), without mutation detection evidence.

Relevance to patient case: not relevant
Patient case: 67-year-old male with esophageal cancer; genetic feature: EGFR

Clinical trial: EGFR Mutation Detection From Advanced NSCLC Patient Tissue and Plasma in EGFR-TKI Treatment

Summary: This study has been designed in order to detect EGFR mutation abundance of tissue and concentration of plasma from Advanced Non-small Cell Lung Cancer during treatment with Tyrosine Kinase Inhibitor (TKI) .Through this experiment the investigators aim to evaluate the feasibility of plasma EGFR detection and evaluate the correlation of EGFR mutations and prognosis.


Eligibility: Inclusion Criteria:
  -  Age older than 18 years and under 75 years
  -  Histologically and cytologically proven non-small Cell Lung Cancer
  -  Clinical stages Ⅲ ~ Ⅳ
  -  Not receive any anti-tumor treatment
  -  Eastern cooperative oncology group performance status (ECOG PS) =1~2
  -  Estimated survival time more than 3 months
  -  EGFR-TKI treatment for first-line or second-line
  -  Voluntary to participate in this clinical trial and sign the consent form
  Exclusion Criteria:
  -  Patients have received EGFR-TKI therapy before the study
  -  With other malignancy history in the recent 5 years before the study
  -  Pregnancy or breast feeding phase
  -  Inadequate samples for testing
  -  Follow-up compliance is poor

Relevance to patient case: not relevant
Patient case: 67-year-old male with esophageal cancer; genetic feature: EGFR

Clinical trial: Combination of Cetuximab With Afatinib for Patient With EGFR Mutated Lung Cancer

Summary: Until recently, the first line treatment of metastatic Non Small Cell Lung Cancer (NSCLC) was a platine-based chemotherapy. It has been changed by the discovery of EGFR (Epidermal Growth Factor Receptor) mutations and associated treatment with Tyrosine Kinase Inhibitor (TKI) of EGFR. The superiority of EGFR TKI over chemotherapy for EGFR mutated patients has been proved in several phase III trials with gefitinib, erlotinib or afatinib.
  Nevertheless, all patients will progress after 9 to 12 months of treatment due to the appearance of a treatment resistance.
  Afatinib is an irreversible EGFR TKI. It binds to its receptor permanently.Contrary to erlotinib and gefitinb which inhibits only EGFR, afatinib inhibits the kinase activity of all HER family (Human Epidermal growth factor Receptor). Nevertheless, there is no proof that afatinib delay the appearance of resistance.
  Cetuximab is a monoclonal antibody which binds specifically with EGFR. The double inhibition of EGFR by afatinib and cetuximab has demonstrated its efficacy in pre-clinical models. The hypothesis of this study is that the combination between cetuximab and afatinib will permit to delay or decrease the appearance of resistances.


Eligibility: Principal Inclusion Criteria:
  -  Stage III or IV NSCLC, non irradiable non operable
  -  Non squamous NSCLC histologically or cytologically confirmed
  -  No previous treatment of NSCLC
  -  EGFR mutation (exon 19 deletion, L858R mutation, G719X , L861Q or S768I mutations or exon 19 insertion)
  -  Presence of at least one lesion that can be measured
  -  PS 0 or 1
  Principal Exclusion Criteria:
  -  Symptomatic brain metastasis or requiring immediate radiotherapy
  -  T790M mutation or exon 20 insertion
  -  Radiotherapy less than 2 weeks prior randomization including symptomatic radiotherapy
  -  Interstitial pneumopathy

Relevance to patient case: not relevant
Patient case: 67-year-old male with esophageal cancer; genetic feature: EGFR

Clinical trial: Study of Inspiratory Muscle Training for Patients Undergoing Esophageal Surgery

Summary: To obtain definitive evidence for the effectiveness of a short preoperative inspiratory muscle training (IMT) protocol on the morbidity and recovery from an esophageal surgical resection.


Eligibility: Inclusion Criteria:
  -  All patients diagnosed with esophageal cancer and scheduled for esophageal resection at the Mayo Clinic Rochester with gastric conduit reconstruction -Cognitively capable to understand and perform a preoperative program
  -  Able to follow the intervention program for at least 2 weeks before surgery (surgery is usually scheduled 4 to 12 weeks after radiation)
  -  Willing to sign the informed consent form
  Exclusion Criteria:
  -  Unable to communicate in the English language
  -  Participating in a conflicting trial concerning esophageal resection

Relevance to patient case: not relevant
Patient case: 67-year-old male with esophageal cancer; genetic feature: EGFR

Clinical trial: Simultaneous Integrated Boost Radiotherapy and Concurrent Nimotuzumab or Chemotherapy for Esophageal Carcinoma

Summary: This prospective, non-randomized phase II study aims to compare radiotherapy and concurrent nimotuzumab with concurrent chemoradiotherapy to obtain a non-inferior pCR rate and pathological lymph node metastases rate in premise of lower toxicities in locally advanced esophageal cancer.

Detailed description: In the era of IMRT and concurrent chemoradiotherapy, the 5-year overall survival of esophageal cancer increase from 10% to about 20%-40%, recurrence rate decrease from 80% to 50%-60%, and local recurrence remains to be the most important type of failure. What called for is to enhance local control without increasing toxicity to improve survival. The investigators have found effective and safe regimen of simultaneously integrated boost radiotherapy in previous study, which can achieve high dose in tumor area with avoid of normal tissues. However, a recent prospective study reported that neoadjuvant chemoradiotherapy resulted in much higher toxicities compares to neoadjuvant chemotherapy (46% vs. 15%, p= 0.04). Although chemoradiotherapy reached a higher pCR rate (28% vs. 9%, p=0.002), patients did not differ in survival in two groups.
  Nimotuzumab is an humanized monoclonal antibody against EGFR. Radiotherapy combines Nimotuzumab reveals synergistic effect in head and neck cancers with lower toxicities as compared to concurrent chemoradiotherapy. Our previous study showed that EGFR expression rate were similar in esophageal cancer and head and neck cancers. Based on above results, the investigators design this study which aims to obtain a non-inferior pCR rate and pathological lymph node metastases rate in premise of lower toxicities.

Eligibility: Inclusion Criteria:
  -  Diagnosis of clinical stage T1-4aN0-1M1a untreated squamous esophageal carcinoma
  -  KPS≥70
  -  Adequate organ function
  -  No known history of drug allergy
  Exclusion Criteria:
  -  Known drug allergy
  -  Insufficient hepatorenal function
  -  Severe cardiovascular diseases, diabetes with uncontrolled blood sugar, mental disorders, uncontrolled severe infection, active ulceration which need intervention.

Relevance to patient case: not relevant
Patient case: 67-year-old male with esophageal cancer; genetic feature: EGFR

Clinical trial: EGFR-TKI With Chemotherapy in NSCLC Patients With Both EGFR Mutation and BIM Deletion Polymorphism

Summary: BIM deletion polymorphism might be associated with a poor clinical response to EGFR-TKIs in patients who had NSCLC with EGFR mutations. In the study, the investigators want to use EGFR-TKI with chemotherapy as first line treatment in stage IIIB/IV NSCLC patients with both EGFR mutation and BIM deletion polymorphism.

Detailed description: BIM deletion polymorphism was a poor clinical response marker to EGFR-TKIs in NSCLC patients who had EGFR mutations. In the study, the investigators want to use EGFR-TKI with chemotherapy as 1 st treatment in stage IIIB/IV NSCLC patients with both EGFR mutation and BIM deletion polymorphism.

Eligibility: Inclusion Criteria:
  Signed informed consent Age >=18 years Histologically documented, unresectable, inoperable, locally advanced, recurrent or metastatic Stage IV Non-Small Cell Lung Cancer (NSCLC) A cytologic diagnosis is acceptable (i.e., FNA or pleural fluid cytology) Must have measurable or non-measurable disease Must be able to comply with study and follow-up procedures
  Exclusion Criteria:
  Small cell, carcinoid, or mixed small cell lung cancer Malignancies within 3 years except for adequately treated carcinoma in situ of -the cervix or basal or squamous cell skin cancer Symptomatic or untreated brain metastases Prior systemic chemotherapy for NSCLC Unstable systemic disease, including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, or myocardial infarction within 6 months prior to Day 1, or serious cardiac arrhythmia requiring medication (patients with chronic atrial arrhythmia, i.e., atrial fibrillation or paroxysmal supraventricular tachycardia, are eligible) History of other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the results of the study or render the patient at high risk from treatment complications Gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for intravenous (IV) alimentation, or prior surgical procedures affecting absorption Pregnancy or lactation

Relevance to patient case: not relevant
Patient case: 67-year-old male with esophageal cancer; genetic feature: EGFR

Clinical trial: A Study of Nivolumab + Chemotherapy or Nivolumab + Ipilimumab Versus Chemotherapy in Patients With EGFR Mutation, T790M Negative NSCLC Who Have Failed 1L EGFR TKI Therapy

Summary: The purpose of this study is to determine whether Nivolumab+ chemotherapy and Nivolumab+Ipilimumab is effective in the treatment of patients with EGFR mutation, T790M negative NSCLC who failed first line (1L) EGFR TKI therapy


Eligibility: For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
  Inclusion Criteria:
  -  Confirmed stage IV or recurrent EGFR Mutation (MT)+ NSCLC with disease progression after 1 prior EGFR TKI therapy
  -  No evidence of exon 20 T790M mutation after progression on prior EGFR tyrosine kinase inhibitor(TKI) therapy.
  -  Measurable disease according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)
  -  Available tumor sample for Programmed death-ligand 1 (PD-L1) immunohistochemical (IHC) and exon 20 T790M testing
  Exclusion Criteria:
  -  Subjects with symptomatic central nervous system (CNS) metastases
  -  Subjects with carcinomatous meningitis
  -  Subjects with an active, known or suspected autoimmune disease are excluded
  -  Subjects with known SCLC transformation
  Other protocol defined inclusion/exclusion criteria could apply

Relevance to patient case: not relevant
Patient case: 67-year-old male with esophageal cancer; genetic feature: EGFR

Clinical trial: Swallowable Sponge Cell Sampling Device and Next Generation Sequencing in Detecting Esophageal Cancer in Patients With Low or High Grade Dysplasia, Barrett Esophagus, or Gastroesophageal Reflux Disease

Summary: This pilot clinical trial studies how well a swallowable sponge cell sampling device and next generation sequencing work in detecting esophageal cancer in patients with low or high grade dysplasia, Barrett esophagus, or gastroesophageal reflux disease. Checking biomarkers in abnormal esophageal cells using a swallowable sponge cell sampling device and next generation sequencing may improve diagnosis and treatment of esophageal cancer.

Detailed description: PRIMARY OBJECTIVES:
  I. Determine the sensitivity and specificity of next generation sequencing for the detection of esophageal cancer from esophageal sponge cytology specimens.
  SECONDARY OBJECTIVES:
  I. Determine the ability of next generation gene sequencing (NGS) of esophageal sponge samples to collect an adequate sample to detect mutations that are present in the underlying tissue.
  II. Determine the cost associated with esophageal cytology with next generation genome sequencing as a screening tool.
  III. Continue to collect safety and tolerability data related to the use of the esophageal sponge.
  IV. Determine the limitations of esophageal sponge cytology and future needs to improve this technique.
  V. Use the data collected to design a larger screening trial to determine the ability of esophageal cytology with next generation sequencing to screen for esophageal cancer in the general population.
  OUTLINE:
  Patients undergo cytology specimen collection procedure using a swallowable sponge cell sampling device.

Eligibility: Inclusion Criteria:
  -  Subjects with known esophageal cancer (adenocarcinoma or squamous cell carcinoma)
  -  Subjects with a history of low or high grade dysplasia
  -  Subjects with risk factors for esophageal malignancy including Barrett's esophagus and gastroesophageal reflux disease (GERD)
  -  Ability to understand and the willingness to sign a written informed consent document
  -  Patients must be scheduled for a procedure capable of providing a definitive pathologic diagnosis and evaluating for complications of the esophageal sponge on the same day as the study procedure, either upper endoscopy or surgical esophagectomy
  Exclusion Criteria:
  -  Subjects that are unable to swallow a tablet/pill
  -  Subjects with completely obstructing esophageal cancer
  -  Subjects with known or suspected esophageal varices
  -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  -  Any condition which, in the opinion of the investigator precludes the patient from completion of the study procedure

Relevance to patient case: not relevant
Patient case: 67-year-old male with esophageal cancer; genetic feature: EGFR

Clinical trial: Sym004 in Metastatic Colorectal Cancer and ECD-EGFR Patients

Summary: This is a single arm, phase 2, open-label, multicenter trial in patients with metastatic colorectal cancer (mCRC) and acquired resistance to anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (mAbs) and documented mutation of extra cellular domain EGFR (ECD-EGFR).


Eligibility: Inclusion and Exclusion criteria have been removed due to Symphogen's business decision to no longer perform the clinical study.

Relevance to patient case: not relevant