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

Clinical trial: Phase II Trial for Patients With Loco-Regional Esophageal Carcinoma

Summary: The purpose of this study is to determine whether bevacizumab can improve the outcome of treatment for patients with esophageal cancer whose disease is confined to the esophagus or the closely surrounding lymph nodes.

Detailed description: Standard treatment is pre-operative chemotherapy and radiation, followed by surgery. In this study, bevacizumab will be added to the pre-operative chemotherapy and radiation, and then bevacizumab will also be administered for a year after surgery. Bevacizumab is a humanized monoclonal antibody (a type of protein that is normally made by the immune system to help defend the body from infection and cancer) produced by Genentech, Inc. using recombinant DNA technology. Bevacizumab has been approved by the FDA for the treatment of metastatic colorectal cancer in combination with chemotherapy. Bevacizumab is experimental in the treatment of esophageal cancer and has not been approved by the FDA for the treatment of esophageal cancer. Bevacizumab is an antibody directed against vascular endothelial growth factor, or VEGF. VEGF is a growth factor with a well defined role in normal and abnormal blood vessel formation. It is present in a wide variety of normal tissues, but is produced in excess by most solid cancers (tumors). In the setting of cancer, VEGF promotes the growth of blood vessels that bring nutrients to tumor cells. In studies with laboratory animals, bevacizumab inhibits the growth of several different types of human cancer cells, including colon cancer cells, by blocking the effects of VEGF. By blocking VEGF, your doctors hope that bevacizumab may decrease blood supply to the tumor, and therefore decrease the ability of the tumor to grow and come back after chemotherapy, radiation, and surgery.

Eligibility: Inclusion Criteria:
  1. No prior treatment for esophageal cancer
  2. No prior radiation to the chest or upper abdominal area
  3. No prior treatment with an EGFR inhibitor or an anti-angiogenic agent
  4. Disease should be limited to the esophagus and regional lymph nodes -
  Exclusion Criteria:
  1. History of stroke
  2. History of heart attack
  3. Inadequately controlled high blood pressure

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

Clinical trial: Endoscopic Mucosal Resection (EMR) in Barrett's Esophagus

Summary: Existing records will be reviewed to evaluate the predictors of complications including stricture formation, bleeding or perforation associated with endoscopic mucosal resection

Detailed description: Barrett's esophagus (BE) is a complication of gastroesophageal reflux disease in which the normal squamous lining of the esophagus is replaced by specialized columnar epithelium.1 Approximately 5%-10% of patients diagnosed with BE are thought to be at risk of developing esophageal adenocarcinoma.2 Patients with high-grade dysplasia (HGD) on biopsy are at the greatest cancer risk³. EMR is being performed clinically in our Barrett's Esophagus Unit on a regular basis during endoscopy for patients with Barrett's Esophagus and/or early esophageal adenocarcinoma. There are two predominant endoscopic mucosal resection (EMR) techniques exist using FDA approved devices - the EMR cap method using a transparent cap/snare combination and the endoscopic variceal ligation method using a band ligator/snare combination to resect tissue.

Eligibility: Inclusion Criteria:
  -  Barrett's Esophagus Early Esophageal Adenocarcinoma History of Endoscopic Mucosal Resection
  Exclusion Criteria:

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

Clinical trial: The Effect of Ablation Therapy on Barrett's Esophagus

Summary: To assess the effect of ablative therapy (Photodynamic Therapy or Radiofrequency ablation ) on Barrett's Esophagus

Detailed description: To assess the effect of ablation therapy on Barrett's esophagus. Proposal Ablation therapy is an FDA approved treatment to decrease cancer risk in Barrett's esophagus mucosa. This is being performed in our Barrett's Esophagus Unit on a regular basis. However, the longterm outcomes of this therapy is not established and there are patients who have been treated who later re-develop Barrett's mucosa. This study will allow us store tissue samples that can later be used to assess the effect of ablative therapy on Barrett's esophagus.

Eligibility: Inclusion Criteria:
  -  Patients who have had or qualify for ablation therapy for treatment of their barrett's esophagus with high grade dysplasia or early esophageal adenocarcinoma
  -  Ability to provide informed consent
  Exclusion Criteria:
  -  Eastern Cooperative Oncology Group performance status 3 or 4
  -  Inability to tolerate endoscopic procedures
  -  Pregnancy: Females of child-bearing age will be screened with pregnancy test.

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

Clinical trial: Oxaliplatin and Docetaxel Followed by Cetuximab for Head and Neck Cancer

Summary: A study of Oxaliplatin and Docetaxel followed by Cetuximab for head and neck cancer patients to determine their effect on the control and reduction of tumor size

Detailed description: This is a non-randomized, open-label, phase II study to assess the effects of oxaliplatin and docetaxel followed by epidermal factor-antibody (EGFR-AB) cetuximab on patients with previously treated recurrent /metastatic squamous cell carcinoma of the head and neck. Head and neck tissue will also be tested to determine if the protein Epidermal Growth Factor Receptor is present in the cancer cells.

Eligibility: Inclusion Criteria:
  -  Histologically or cytologically confirmed recurrent SCCHN
  -  18 years or older
  -  Tumor site accessible by biopsy
  -  Measurable disease
  -  Receiving no other therapy
  -  ECOG performance status 0-1
  -  Adequate bone marrow, renal function and hepatic function
  Exclusion Criteria:
  -  Active infection or fever within 3 days of treatment
  -  Active CNS metastases
  -  Prior malignancy within 5 years
  -  Hypersensitivity to study drugs
  -  Chemotherapy within 30 days of treatment
  -  Concurrent investigational therapy within 30 days
  -  Radiotherapy of more than 25% of bone marrow
  -  Peripheral neuropathy of grade 2 or greater
  -  Pregnant or lactating patients
  -  History of allogeneic transplant
  -  Active or previously treated HIV or Hepatitis B or C
  -  Patients with a tracheostomy

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

Clinical trial: Quality Of Life Outcomes Following Treatment for Esophageal Cancer

Summary: The goal of this study is to evaluate how treatment for esophageal cancer affects your quality of life. The findings of this study may help us understand how this disease and its treatment affect your lifestyle, diet, exercise, support system and overall quality of life. We hope this study will provide important information that can be used to develop programs to improve the quality of life of patients with esophageal cancer.

Detailed description: In order to determine the impact of esophageal cancer and its treatment on patients' quality of life over time, this study will prospectively follow a cohort of patients at specified intervals, evaluating their physical symptoms, physical and social functioning and overall quality of life. Medical and sociodemographic factors as well as health behaviors that might be predictive of adaptation will be tested. This is a preliminary investigation and it is hoped that we will be able to base future research questions on the results of this study.

Eligibility: Inclusion Criteria:
  -  Age 18 or older
  -  Diagnosis of esophageal cancer.
  -  Anticipated to undergo surgical resection (Ivor Lewis, Trans Hiatal, McKeown procedure) of esophageal cancer. (Group 1 patients only)
  -  Underwent esophagectomy for esophageal cancer at least 18 months prior to consent, with no evidence of disease. (Group 2 patients only)
  -  Ability to speak, read and write English.
  Exclusion Criteria:
  -  Inability to give informed consent.
  -  Patients anticipated to require a laryngectomy as part of their surgical resection.

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

Clinical trial: The Effects of Sorafenib on Molecular Barrett's Esophagus Cancer

Summary: To determine whether sorafenib is able to change pre-cancerous cells in a way that we believe is important in the progression of cancer.

Detailed description: To characterize the effects of sorafenib on specific molecular markers in patients with Barrett's esophagus and high grade intraepithelial neoplasia (HGIN) or carcinoma in situ (CIS).

Eligibility: Inclusion Criteria:
  -  ECOG performance status 0-2
  -  Life expectancy of greater than 12 months
  -  No prior history of esophageal surgery or endoscopic treatment of dysplasia
  -  No prior exposure to sorafenib
  -  Patients may not be receiving any other investigational agents or any concomitant antineoplastic therapy, with the exception of androgen ablating agents (for patients with prior prostate cancer)
  -  Age 18 years.
  -  Patients must have adequate organ and marrow function as defined below:
  -  hemoglobin: 8.5 g/dL
  -  absolute neutrophil count: 1,500/L
  -  platelets: 100,000/L (greater than 35,000/L without transfusion for less than 1 X the institutional upper limit of normal)
  -  creatinine less than 1.5 X institutional upper limit of normal
  -  Ability to understand and the willingness to sign a written informed consent.
  Exclusion Criteria:
  -  A patient will be withdrawn from the study if any of the following events occur while on therapy:
  -  Interruption of scheduled therapy for greater than 7 days
  -  Intolerable adverse effects which are judged by the investigator to be either physically or psychologically detrimental to the patient
  -  Patient decision to discontinue treatment
  -  Pregnancy
  -  Patient non-compliance with therapy administration
  -  Grade 3 or 4 NCI-CTC toxicity attributable to sorafenib
  -  Treatment with other chemotherapeutic or investigational anti-neoplastic drugs
  -  Disease progression
  -  HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with sorafenib.Appropriate studies will be undertaken in patients receiving combination anti-retroviral therapy when indicated.

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

Clinical trial: Biological Factors in Predicting Response to Treatment in Patients With Esophageal Cancer or Rectal Cancer

Summary: RATIONALE: Studying samples of tumor tissue and 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. It may also help doctors predict how patients will respond to treatment.
  PURPOSE: This clinical trial is studying how well biological factors work in predicting response to treatment in patients with esophageal cancer or rectal cancer.

Detailed description: OBJECTIVES:
  Primary
  -  Analyze various biological factors that can be used as markers to predict response to treatment and correlate with the signaling pathway of EGFR.
  Secondary
  -  Establish a tissue bank to store information about the response to treatment and survival.
  OUTLINE: Patients undergo endoscopy, 11 biopsies of tumor tissue, and 3 biopsies of healthy mucosa. Blood samples are also collected. Samples are analyzed for the expression of 4 receptors in the EGFR family, polymorphisms at intron 1 of the EGFR gene, and gene mutations in downstream signaling pathways.
  After surgery, patients are followed every 3 months.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically confirmed adenocarcinoma or squamous cell carcinoma of the esophagus or rectum
  -  Planning to receive neoadjuvant treatment, including radiotherapy or chemoradiotherapy
  PATIENT CHARACTERISTICS:
  -  Not pregnant or nursing
  -  No blood disorder
  -  Not deprived of freedom or protected by law
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics

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

Clinical trial: Combination of Chemoradiation Therapy and Epitope Peptide Vaccine Therapy in Treating Patients With Esophageal Cancer

Summary: The purpose of this study is to evaluate the safety and immune response of multiple peptides (URLC10, TTK, KOC1 VEGFR1, and VEGFR2) emulsified with Montanide ISA51 in combination with chemotherapy (CDDP, 5-FU) plus radiation therapy in treating patients with unresectable, advanced or recurrent esophageal cancer.

Detailed description: Up-regulated ling cancer 10 (URLC10), TTK protein kinase (TTK) and K homology domain containing protein over expressed in cancer (KOC1) were identified as new targets of tumor associated antigens using cDNA microarray technologies combined with the expression profiles of normal and cancer tissues. Furthermore, anti-angiogenic therapy is now considered to be one of promising approaches for treating cancer. Vascular endothelial growth factor receptor 1 (VEGFR1) and vascular endothelial growth factor receptor 2 (VEGFR2) are essential targets for tumor angiogenesis. Epitope peptides for these targets are able to induce cytotoxic T lymphocytes (CTL) restricted to HLA-A *2402 in vivo. On the other hand, chemotherapy (CDDP, 5-FU) plus radiation therapy has been to be a standard treatment for unresectable advanced esophageal cancer. In this clinical trial, we evaluate the safety and immune responses of different doses of multiple peptides (URLC10, TTK, KOC1, VEGFR1, and VEGFR 2) emulsified with Montanide ISA 51 in combination with chemotherapy (CDDP, 5-FU) plus radiation therapy in treating patients with unresectable, advanced or recurrent esophageal cancer.

Eligibility: Inclusion Criteria:
  1. Patients must have unresectable, locally advanced, recurrent or metastatic disease of esophageal cancer.
  2. measurable disease by CT scan
  3. ECOG performance status of 0 to 2
  4. Expected survival of at lease 3months
  5. Patients must be HLA-A2402
  6. Laboratory values as follow:
  -  WBC > 2000/mm3,
  -  Platelet count > 75000/mm3,
  -  Total bilirubin < 1.5 x the institutional normal upper limits,
  -  Creatinine < 1.5 x the institutional normal upper limits,
  -  AST. ALT. ALP < 2.5 x the institutional normal upper limits
  7. Able and willing to give valid written informed consent
  Exclusion Criteria:
  1. Pregnancy (women of childbearing potential:Refusal or inability to use effective means of contraception)
  2. Breastfeeding
  3. Active or uncontrolled infection
  4. Prior chemotherapy,radiation therapy or immunotherapy within 4 weeks
  5. Concurrent treatment with steroid or immunosuppressing agent
  6. Patient with peptic ulcer disease
  7. Active or uncontrolled other malignancy
  8. Other malignancy within 5 years prior to entry into the study, expect for treated non-melanoma skin cancer and cervical carcinoma in situ
  9. Disease to the central nervous system
  10. Decision of unsuitableness by principal investigator or physician-in-charge

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

Clinical trial: Detection of Anastomotic Leakage After Esophageal Surgery

Summary: Anastomotic leakage is a major complication in esophageal surgery. Although contrast swallow is the current standard to exclude anastomotic leakage postoperatively, endoscopy may be superior. This is the first study to compare radiographic contrast study and endoscopy for the identification of local complications after subtotal esophagectomy.

Detailed description: This prospective, blinded, intraindividual controlled study will be conducted with patients with transthoracic esophagectomy due to esophageal cancer. A radiographic contrast study will be performed prior to endoscopy at the 5th to 7th postoperative day. The investigators will not be aware of the results of the corresponding examination. Sensitivity, specificity and feasibility of the radiologic and endoscopic evaluation of the esophageal substitute will be compared.

Eligibility: Inclusion Criteria:
  -  Patients with primary esophageal cancer undergoing transthoracic esophagectomy.
  Exclusion Criteria:
  -  no transthoracic resection
  -  no primary anastomosis
  -  recurrent disease
  -  refusal to participate

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

Clinical trial: Cryotherapy for Barrett's Esophagus and Early Esophageal Cancers

Summary: This is a single center study to evaluate the efficacy and safety of a new ablation technique involving the spray of liquid nitrogen through a catheter (cryotherapy) via an upper endoscopy (EGD) to ablate Barrett's esophagus with changes of high-grade dysplasia (HGD) or intramucosal cancer (IMCA) and patients with esophageal cancer limited to the esophageal wall, in whom there are no standard treatment options available.

Detailed description: The Cryo-Ablator System is a cryosurgical unit with a liquid nitrogen cooled cryocatheter and accessories to destroy tissue during surgical procedures by applying extreme cold.
  Patients will prepare for esophagogastroduodenoscopy (EGD) in the standard fashion using an overnight fast with only clear liquids and required medications allowed up to 2 hours before the procedure. The EGD will be performed using a therapeutic Olympus endoscope. The cryocatheter is passed into the therapeutic channel of the endoscope. Liquid nitrogen is sprayed through the cryocatheter for a duration of 10 seconds as measured by the device integrated timer. This process will be repeated four times in piecemeal fashion such that for any given area treated it will be maintained in a frozen state for a total of 40 seconds. Following circumferential treatment, the process will be repeated again applying the spray to the same section of mucosa for a duration of 20 seconds. Patients will be contacted the following day to assess for any immediate complications.
  Patients will repeat treatment every 6 weeks if no evidence of esophageal mucosal injury, until complete ablation of the Barrett's mucosa has been achieved. Follow up period of five years to monitor healing and progression.

Eligibility: Inclusion Criteria:
  Group 1:
  -  Co-morbid conditions such as severe heart, lung, kidney or liver disease.
  -  Refusal of surgical intervention after a thorough discussion of the highly experimental nature of cryotherapy.
  Group 2:
  -  Patients with inoperable esophageal cancer (adenocarcinoma oe squamous cell CA) with lesions extending beyond the mucosa but limited to the esophageal wall
  Exclusion Criteria:
  -  Age less than 18 years
  -  Co-morbid illness expected to cause death within 6 months
  -  Pregnancy
  -  Refusal or inability to give consent

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

Clinical trial: Histocompatibility Leukocyte Antigen (HLA)-A*0201 Restricted Peptide Vaccine Therapy in Patients With Esophageal Cancer

Summary: The purpose of this study is to evaluate the safety and time to progression of HLA-A*0201 restricted epitope peptides URLC10, VEGFR1 and VEGFR2 emulsified with Montanide ISA 51.

Detailed description: URLC10 has been identified as cancer specific molecules especially in non small cell lung cancer using genome-wide expression profile analysis by cDNA microarray technique. In a prior study, it has been shown that URLC10 is upregulated in human esophageal tumors. VEGF receptor 1 and 2 are essential targets to tumor angiogenesis, and we identified that peptides derived from these receptors significantly induce the effective tumor specific CTL response in vitro and vivo. According to these findings, in this trial, we evaluate the safety, immunological and clinical response of those peptides. Patients will be vaccinated twice a week for 8 weeks. On each vaccination day, the URLC10-117 peptide(1mg), VEGFR1 peptide(1mg) and VEGFR2 peptide(1mg) mixed with Montanide ISA 51 will be administered by subcutaneous injection. Repeated cycles of vaccine will be administered until patients develop progressive disease or unacceptable toxicity, whichever occurs first. In the phase I study, we evaluate the safety and tolerability of these peptide vaccines. In the following phase II study, we evaluate the immunological and clinical response of this vaccine therapy.

Eligibility: Inclusion Criteria:
  -  Advanced or recurrent esophageal cancer
  -  Resistant against conventional chemotherapy or difficult to continue the chemotherapy due to intolerable side effect(s)
  -  ECOG performance status 0-2
  -  Life expectancy > 3 months
  -  HLA-A*0201
  -  Laboratory values as follows 2000/mm3<WBC<15000/mm3 Platelet count>100000/mm3 Bilirubin < 3.0mg/dl Asparate transaminase < 150IU/L Alanine transaminase < 150IU/L Creatinine < 3.0mg/dl
  -  Able and willing to give valid written informed consent
  Exclusion Criteria:
  -  Pregnancy (woman of childbearing potential:Refusal or inability to use effective means of contraception)
  -  Breastfeeding
  -  Active or uncontrolled infection
  -  Unhealed external wound
  -  Concurrent treatment with steroids or immunosuppressing agent
  -  Prior chemotherapy, radiation therapy, and/or immunotherapy within 4 weeks
  -  Uncontrolled brain and/or intraspinal metastasis
  -  Decision of unsuitableness by principal investigator or physician-in-charge

Relevance to patient case: possibly relevant