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

Clinical trial: Concurrent Chemoradiotherapy Containing Paclitaxel&Cisplatin With/Without Tarceva in Locally Advanced Esophageal Cancer

Summary: This study is multi-center randomized phase III one to evaluate the difference in local-control and survival rate between patients receiving concurrent chemoradiotherapy combined Tarceva or not.

Detailed description: For the esophageal carcinoma in II~III stage, routine dosage of Paclitaxel and platinum medicine chemotherapy concurrently radical radiotherapy is worthy to be studied. On this base, we advanced approach the enlarged field radiotherapy and the intervention of Tarceva. And we approach the therapeutic effect for this method theoretically, which may give a further reasonable guidance for the clinical therapy.

Eligibility: Inclusion Criteria:
  1. Subjects must be confirmed Esophageal Carcinoma pathologically
  2. (EUS)I～IVa, without contraindication for radical radiotherapy
  3. Subjects haven't been given neither radiotherapy nor chemotherapy before
  4. Age 18-70,behavioral status evaluation ECOG scores 0—2 and anticipated survival more than 6 months
  5. In 7 days after being selected, subjects should follow the status: WBC ≥ 4.0 x 10^9/L; ANC ≥ 1.5x 10^9/L; PLT ≥ 100 x 10^9/L; Hb ≥ 90 g/L; serum Cr ≤ ULN; serum bilirubin ≤ 1.5 ULN; ALT/AST ≤ 1.5 ULN
  6. Subjects should sign for the informed consent
  7. Subjects should perform good compliance
  8. Male and female subjects who have the ability of fertility should take contraception during the whole course and also 3 months after last dosage.In 7 days before the inclusion, urine pregnancy tests of subjects should be negative.
  Exclusion Criteria:
  1. Patients who have or are currently undergoing additional chemotherapy, radiation therapy or targeted therapy
  2. Complete obstruction of the esophagus, or patients who have the potential to develop perforation
  3. Patients with a history of malignancy (except that skin carcinomas or in situ breast cancer, oral cancer and cervical cancer with expected survival ≥2 years
  4. Patients who multiple foci esophagus
  5. Patients who are/were given any other medicine tests currently/in last 4 weeks
  6. Experienced hypersensitiveness with similar medicine or other kinds of bio-medicines
  7. Women in status of pregnancy
  8. Patients who have complications exist as following:
  (1)Uncontrolled angina and heart failure, have a history of hospitalization in 3 months; (2)A history of myocardial infarction in the past 6 months; (3)There is a need for antibiotic treatment of acute bacterial or fungal infection; (4)Chronic obstructive pulmonary disease, or other lung disease requiring hospitalization; (5)Drug addiction, alcoholism and AIDS disease or long-term virus carriers; (6)Uncontrollable seizures, or loss of insight because of mental illness

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

Clinical trial: Mediastinal Microdialysis in Patients With Oesophageal or Cardia Cancer Treated by Resection

Summary: Postoperative anastomotic leakage is a serious complication in patients with oesophageal or cardia cancer. Early diagnosis and treatment are mandatory. The primary aim of the present study is to investigate the clinical use of mediastinal microdialysis and whether is able to detect anastomotic leakage prior to the development of clinical symptoms.

Detailed description: Patients undergoing oesophageal or cardia resection for cancer are monitored by mediastinal microdialysis during the postoperative period. Subcutaneous microdialysis serves as a control. Samples are collected every 4-hour. Samples will be analyzed continuously but the results will not be included in the clinical evaluation of the patient.
  A total of 30 patients will be included in this pilot study. The results of the mediastinal microdialyses will be compared with the clinical course in each patient. The results form the uncomplicated courses will be used to define the normal variations in mediastinal microdialysis. This will be compared to results from patients with various complications.

Eligibility: Inclusion Criteria:
  -  Histological verified oesophageal or cardia cancer
  Exclusion Criteria:
  -  Lack of consent, otherwise none

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

Clinical trial: A Dose-Escalation Study of RO5083945 in Patients With Metastatic and/or Locally Advanced Malignant Epidermal Growth Factor Receptor (EGFR)+ Solid Tumors.

Summary: This study will evaluate the pharmacokinetics, maximum tolerated dose and anti-tumor activity of RO5083945 in patients with metastatic and/or locally advanced malignant EGFR+ solid tumors. In the first part of the study, groups of patients will be sequentially enrolled to receive ascending doses of RO5083945 administered weekly, every 2 weeks or every 3 weeks. The starting dose of 50mg weekly will be escalated in subsequent groups of patients after a successful assessment of the safety, tolerability and pharmacokinetics of the previous dose. In Part 2 of the study, patients with EGFR+ and mutant KRAS colorectal cancer will be enrolled, and will receive RO5083945 at the recommended dose and regimen identified in Part 1. The anticipated time on study treatment is until disease progression, and the target sample size is <100 individuals.


Eligibility: Inclusion Criteria:
  -  adult patients, >=18 years of age;
  -  centrally confirmed EGFR expression in tumor tissue;
  -  radiologically measurable or clinically evaluable disease;
  -  last dose of systemic anti-neoplastic therapy or radiotherapy >=28 days prior to start of study;
  -  histologically or cytologically confirmed advanced stage, primary or metastatic EGFR+ solid tumors (Part 1);
  -  histologically or cytologically confirmed advanced stage, primary or metastatic EGFR+ and mutant KRAS colorectal cancer (Part 2);
  -  not more than 2 previous cytotoxic regimens for metastatic disease (Part 2).
  Exclusion Criteria:
  -  history of grade 3-4 toxicity resulting from previous anti-EGFR treatment;
  -  known or suspected CNS metastases;
  -  wild type KRAS colorectal cancer (Part 2).

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

Clinical trial: A Phase I Study of the Safety, Pharmacokinetics, and Anti-Tumor Activity of CUDC-101 in Patients With Advanced Solid Tumors

Summary: This is a phase I, open-label, dose-escalation study of CUDC-101 in patients with advanced and refractory solid tumors. CUDC-101 is a multi-targeted agent designed to inhibit epidermal growth factor receptor (EGFR), human epidermal growth factor receptor Type 2(Her2) and histone deacetylase (HDAC). The study is designed to establish the safety, including the maximum tolerated dose, the pharmacokinetics, and the anti-tumor activity of CUDC-101.


Eligibility: Inclusion Criteria:
  -  Subjects with advanced, refractory solid tumors and a histopathologically confirmed diagnosis
  -  Subjects must have no further standard of care options or have refused standard therapy
  -  Measurable or evaluable disease
  -  Age ≥ 18 years
  -  ECOG performance < 2
  -  Life expectancy ≥ 3 months
  -  If female, neither pregnant or lactating
  -  If of child bearing potential, must use adequate birth control
  -  Absolute neutrophil count ≥ 1,500/µL; platelets ≥ 100,000/µL;
  -  Creatinine ≤ 1.5x upper limit of normal (ULN) or calculated creatinine clearance ≥ 60mL/min/1.73m2
  -  Total bilirubin ≤ 1.5x ULN; AST/ALT ≤ 2.5x ULN. In subjects with documented liver metastases, the AST/ALT may be ≤ 5x ULN
  -  Prothrombin time ≤1.5x ULN, unless receiving therapeutic anticoagulation
  -  Serum magnesium and potassium within normal limits (may be supplement to achieve normal values)
  -  Subjects with brain metastases are eligible if controlled on a stable dose ≤ 10mg prednisone/day or its equivalent dose of steroids
  -  Able to render informed consent and to follow protocol requirements.
  Exclusion Criteria:
  -  Anticancer therapy within 4 weeks of study entry. Prostate cancer subjects on LHRH hormonal therapy may be enrolled and continue on this therapy.
  -  Use of investigational agent(s) within 30 days of study entry
  -  History of cardiac disease with a New York Heart Association (NYHA) Class II or greater congestive heart failure (CHF), myocardial infarction (MI) or unstable angina in the past 6 months prior to Day 1 of treatment, serious arrhythmias requiring medication for treatment.
  -  Known infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C.
  -  The following are permitted but should be used with caution and other suitable agents used if possible:
  -  Subjects receiving concomitant medications metabolized by CYP 3A4 and CYP 2D6
  -  CYP3A4 inducers
  -  CYP3A4 inhibitors
  -  Warfarin

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

Clinical trial: Chemotherapy Induction and Chemoradiotherapy in Patients With Esophageal Carcinoma

Summary: The aim of this study is the evaluate the feasibility and safety of chemotherapy induction treatment combined with cetuximab followed by chemoradiotherapy combined with cetuximab in the treatment of patients with non-metastatic esophageal cancer.

Detailed description: Patients with a locoregional carcinoma of the esophagus or gastro-esophageal junction have a low survival prognosis following surgical resection. In studies published to date no positive effect upon overall survival could be demonstrated for preoperative chemotherapy or chemoradiotherapy. However, patients with a complete remission following preoperative therapy show prolonged survival.
  This study design is based upon decreasing primary tumour and preventing oder delaying micrometastases by means of a chemo induction therapy, increasing R0 resection rates and preventing local recurrence by means of preoperative chemoradiotherapy, increasing the radiosensitivity of tumour cells through treatment combination with cetuximab, surgical resection of the locoregional primary tumour or definitive radiochemotherapy in case the primary tumour is inoperable.
  The aim of this study is therefore to evaluate the feasibility and safety of a 3-staged therapy approach including an EGFR antibody in the treatment of patients with potentially resectable esophageal cancer, as well as the evaluation of objective response rates to this preoperative therapy.

Eligibility: Inclusion Criteria:
  -  Signed informed consent
  -  histologically confirmed esophageal cancer (squamous cell carcinoma)
  -  measurable, non-metastatic disease (uT1-4)
  -  no previous cancer therapy (chemotherapy, radiotherapy or resection)
  -  life expectancy > 3 months
  -  age > 18 years
  -  WHO Status ≤ 2
  -  negative pregnancy test for women of child-bearing potential, and use of adequate contraception
  -  hematological status: neutrophiles ≥ 1,5x10E9/L, thrombocytes ≥ 100x10E9/L
  -  adequate renal function: serum creatinine ≤ 1,5 x ULN
  -  adequate liver function: alkaline phosphatase < 2,5 x ULN, total bilirubin < 1,5 x ULN
  Exclusion Criteria:
  -  pregnant or nursing women
  -  women of child-bearing potential without adequate contraception
  -  concomitant anti-tumoral therapy except study mandated procedures
  -  cervical esophageal cancer or diagnosis of metastases
  -  participation in other clinical trials within the last 30 days
  -  history of malignant disease within the last 5 years
  -  peripheral neuropathy (NCI CTC ≥ grade 1)
  -  concurrent active and serious non-malignant diseases: uncontrolled heart insufficiency, angina pectoris, hypertension or arrhythmias, liver disease, significant neurological or psychiatric conditions
  -  active infections

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

Clinical trial: Study of Genes and the Environment in Patients With Prostate Cancer Residing in the East Anglia, Trent, or West Midlands Regions of the United Kingdom

Summary: RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.
  PURPOSE: This study is looking at genetic susceptibility and the interactions between genes and the environment in patients with prostate cancer.

Detailed description: OBJECTIVES:
  -  To obtain epidemiological information and biological material on a population-based series of prostate cancer cases.
  -  To identify novel cancer susceptibility genes by comparison of genotype frequencies in cases with the corresponding frequencies in large control series.
  -  To estimate the age and sex-specific risks associated with variants in predisposition genes.
  -  To evaluate interactions between polymorphisms in predisposition genes and potential lifestyle risk factors.
  OUTLINE: This is a multicenter study.
  Patients complete a detailed epidemiological questionnaire, including information on education, occupation, smoking habits, alcohol consumption, height, weight, family history of cancer, and past medical history.
  Blood samples are collected from patients. DNA is extracted from these blood samples and from samples collected from cancer-free control participants in MREC-SEARCH-CONTROL as well as from additional controls through the European Prospective Investigation of Cancer (EPIC) study (a population based study of diet and health based in Norfolk, East Anglia). DNA samples are analyzed for polymorphisms of low penetrance cancer susceptibility genes.
  In addition to the prostate cancer patients recruited for this study, patients with breast, ovarian, endometrial, colorectal, bladder, kidney, pancreatic, brain and esophageal cancer, malignant melanoma, and lymphoma cancer are recruited in the following related clinical trials: MREC-SEARCH-BREAST, MREC-SEARCH-OVARIAN, MREC-SEARCH-ENDOMETRIAL, MREC-SEARCH-COLORECTAL, and MREC-SEARCH-CANCER.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of prostate cancer within the past 5 years
  -  Identified through the cancer registry serving any of the following geographic regions of the United Kingdom:
  -  East Anglia
  -  Trent
  -  West Midlands
  PATIENT CHARACTERISTICS:
  -  Identified by the patient's general practitioner as fit to contact for this study
  -  No serious mental illness or retardation
  PRIOR CONCURRENT THERAPY:
  -  Not specified

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

Clinical trial: Afatinib and Vinorelbine in Tumours Known to Overexpress EGFR and/or HER2

Summary: To determine the maximum tolerated dose, safety, pharmacokinetics and anti-tumour efficacy of oral BIBW 2992 in combination with intravenous or oral vinorelbine


Eligibility: Inclusion criteria:
  -  Histologically or cytologically confirmed diagnosis of malignancy that is now advanced, non resectable and/or metastatic
  -  Tumours historically known to overexpress EGFR and/or HER2
  Exclusion criteria:
  -  Prior treatment with HER2 inhibiting drugs within the past 4 weeks before the start of therapy or concomitantly with this trial.
  -  Prior treatment with EGFR inhibiting drugs within the past two weeks before the start of therapy or concomitantly with this trial.

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

Clinical trial: Multicentre Study to Explore the Correlation Between Smoking Pattern and Clinical Efficacy of Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor (TKI) in Male Patients

Summary: The objective is to investigate the correlation between smoking pattern and clinical efficacy of EGFR TKIs in male patients with locally advanced or metastasized non-small cell lung cancer of adeno histology who have failed 1st line chemotherapy. Health care resource usage, quality of life (EQ-5D) and practice of EGFR mutation test will also be evaluated. Current practice of EGFR mutation testing in Taiwan will be surveyed.


Eligibility: Inclusion Criteria:
  -  Male patients age 20 years or older
  -  Histological or cytological confirmation of NSCLC of adeno histology. If sputum is the only available sample, a second positive test is necessary for cytological confirmation
  -  Locally advanced or metastatic on or after first-line chemotherapy. Imaging evidence of disease progression can be either chest X ray, CT or MRI assessment on measurable lesions. If no measurable lesion is available, evaluable lesions are acceptable

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

Clinical trial: Endoscopy Screening for Esophageal Cancer

Summary: Patients with head and neck cancer frequently develop synchronous or metachronous esophageal malignancies. Previous studies have demonstrated the efficacy of endoscopic screening for esophageal cancer in head and neck cancer patients. The Narrow Band Imaging (NBI) system, an optical technology that enhances the visualization of superficial vascular network, may be superior to the conventional white light endoscopy for the detection of neoplastic lesions. However, whether the application of NBI improves the detection results have not been critically evaluated.
  This study aims to investigate the diagnostic value of the NBI system in the endoscopic screening for esophageal neoplastic lesions in patients with head and neck cancer.

Detailed description: This is a prospective blinded controlled tandem endoscopy trial conducted in a regional medical center (Lotung Poh-Ai Hospital, Taiwan). Patients with tissue diagnosis of head and neck cancer are enrolled. Endoscopy screening for esophageal lesions is first performed by using the conventional white light system. Suspicious lesions are recorded. Then the entire esophagus is examined under the NBI system by another endoscopist, who is blinded to the result of the conventional endoscopy. After the endoscopic inspection completed, all suspicious lesions are biopsied. Before each procedure, which one of the two participating endoscopists applies the conventional or NBI system is randomized. The diagnostic rate of esophageal neoplasm by the conventional white light system and that of the NBI system are compared.
  The endpoint is the neoplastic lesion detected on endoscopic biopsy. We considered invasive cancer, carcinoma in-situ, and high-grade dysplasia (which usually cannot be distinguished from carcinoma in situ) as the primary points. Any dysplastic lesions were considered as secondary points.

Eligibility: Inclusion Criteria:
  -  patients with tissue diagnosis of head and neck cancer
  -  histopathology of head and neck cancer is carcinoma (including squamous cell carcinoma, adenocarcinoma or undifferentiated)
  -  aged more than 18 years old
  -  agree to under go upper gastrointestinal endoscopy
  Exclusion Criteria:
  -  lack of written informed consent
  -  the origin of head and neck cancer is metastatic
  -  histopathology of head and neck cancer is not carcinoma (e.g., sarcoma, lymphoma, etc)
  -  incomplete upper gastrointestinal endoscopy

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

Clinical trial: Nimotuzumab in Combination With Chemoradiation 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 I study assessed the safety, and efficacy of the combination of Nimotuzumab administered concomitantly with chemo-radiotherapy in patients with locally advanced esophageal cancer tumours.


Eligibility: Inclusion Criteria:
  -  Informed consent form signed before performing any of the study's specific procedures.
  -  ECOG performance status 0-2.
  -  Age > 18 and < 75.
  -  Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) criteria, greater than or equal to 1 cm (longest diameter) by spiral computed tomography (CT) scan and MRI or greater than or equal to 2 cm by other ordinary radiographic technique.
  -  Histologically confirmed diagnosis of locally advanced esophageal.
  -  Life expectancy of more than 3 months.
  -  Use of an effective contraceptive method for patients of both sexes when there is a risk of conception and/or pregnancy.
  -  No serious blood producing,abnormal function of heart,lung, liver, or kidney or immuno-deficiency
  -  Neutrophils ≥3×109/L, platelet count≥100×109/L and haemoglobin≥9g/dL ,Creatinine ≤ 1.5 x NUL
  Exclusion Criteria:
  -  Previous radiotherapy or chemotherapy
  -  Pregnant or breast-feeding women
  -  Drug abuse, unhealthy drug/alcohol addiction,or virus (HIV) infection
  -  Evidence of distant metastasis
  -  Participation in other clinical trials
  -  Patients with aphthosis, complete obstruction, fistula or deep peptic ulcer in the esophagus, or haematemesis
  -  Uncontrolled psychiatric disease or seizure
  -  Patients not fit for the clinical trial judged by the investigators

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

Clinical trial: Genetic and Environmental Risk Factors Related to Esophageal Cancer

Summary: RATIONALE: Gathering information about genes, cigarette smoking, and diet may help doctors learn more about risk factors that may cause esophageal cancer.
  PURPOSE: This clinical trial is studying genetic and environmental risk factors related to esophageal cancer.

Detailed description: OBJECTIVES:
  -  Examine the role of several genetically-determined factors in combination with cigarette smoking and diet in the etiology and prevention of esophageal cancer.
  -  Identify polymorphisms in metabolizing enzymes (e.g., phase I or II metabolism [GSTM1, GSTT1,CYP1A1, CYP3A5, mEH, NQO1, GSTP1], DNA repair [XRCC1, ERCC2], free-radical formation [MPO, MnSOD], inflammatory genes [ IL1-beta], metastatic potential [MMP1], and cell cycle or tumor suppression [p21, p53]) and related path genes of susceptibility for esophageal cancer.
  OUTLINE: Blood and tumor tissue samples are collected. DNA purified from these samples is analyzed using DNA-based assays to determine polymorphisms in various related gene pathways.
  Patients complete questionnaires concerning environmental, smoking and diet habits.
  PROJECTED ACCRUAL: A total of 1,000 tissue samples from patients and healthy participants (750 patients and 250 healthy participants) will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Meets 1 of the following criteria:
  -  Diagnosis of esophageal cancer (patient)
  -  Newly diagnosed disease
  -  Receiving care at Massachusetts General Hospital, Thoracic Oncology Center
  -  Friend or spouse of patient (healthy participants)
  PATIENT CHARACTERISTICS:
  -  No concurrent psychiatric incapacity or dementia
  PRIOR CONCURRENT THERAPY:
  -  Not specified

Relevance to patient case: not relevant