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

Clinical trial: Survival Outcomes and Tumor Molecular Profile Following Bicalutamide Neoadjuvant Therapy

Summary: As clinical primary endpoints we assessed whether existed differences in:
  1. PSA recurrence rate stratified according to treatment modalities
  2. EGFR and HER2/neu overexpression rate stratified according to treatment modalities
  3. PSA recurrence rate stratified according to EGFR and HER2/neu overexpression levels.
  As secondary clinical endpoints we assessed whether existed differences in:
  1. prostate cancer-specific mortality according to treatment modalities
  2. prostate cancer-specific mortality stratified according to EGFR and HER2/neu overexpression levels.
  For this purpose a post treatment PSA-doubling time of less than 3 months found following PSA recurrence was considered as a surrogate endpoint for prostate cancer-specific mortality Pre-clinical endpoints As pre-clinical endpoint we assessed whether exist differences in efficacy rate of Bicalutamide and Gefitinib treatment in primary tumor cultures stratified for high and low EGFR and HER2/Neu expression levels. The evaluation of efficacy rate of these treatments was documented by comparing the differences of drugs IC50 values among the groups stratified for EGFR and HER2/Neu levels.


Eligibility: Inclusion Criteria:
  -  Patients were eligible if they had histologically confirmed adenocarcinoma of the prostate and the following high-risk features: (1) clinical stage T3a disease with (2) Gleason sum of 7 with a predominant component of 4 (i.e., Gleason 4 + 3 = 7) or (4) Gleason sum of 8, 9 or 10.
  Exclusion Criteria:
  -  Prior hormonal therapy,
  -  Prior radiation,
  -  Prior investigational agents,
  -  Prior malignancy within the last five years or had any other serious medical or psychiatric condition or illness that would not permit the patient to be managed according to the protocol were excluded.

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

Clinical trial: Study of Panitumumab Efficacy in Patients With Recurrent and/or Metastatic Head and Neck Cancer

Summary: The purpose of this study is to determine the treatment effect of Panitumumab in combination with chemotherapy versus chemotherapy alone as first line therapy for metastatic and/or recurrent squamous cell carcinoma of the head and neck.


Eligibility: Inclusion Criteria:
  -  Man or woman at least 18 years old.
  -  Histologically or cytologically confirmed metastatic and/or recurrent squamous cell carcinoma (or its variants) of the head and neck.
  -  Diagnosis of metastatic disease and/or recurrent disease following locoregional therapy and determined to be incurable by surgery or radiotherapy.
  -  Subjects who have received radiation as primary therapy are eligible if locoregional recurrence is in the field of radiation and has occurred ≥6 months after the completion of radiation therapy. Subjects whose locoregional recurrence is solely outside the field of radiation are eligible if the recurrence has occurred ≥ 3 months after the completion of radiation therapy.
  -  Measurable and non-measurable disease.
  -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  Exclusion Criteria:
  -  History or known presence of Central Nervous System (CNS) metastases.
  -  History of another primary cancer, except: curatively treated in situ cervical cancer, or curatively resected non-melanoma skin cancer, or other primary solid tumor curatively treated with no known active disease present and no treatment administered for ≥ 2 years before randomization.
  -  Nasopharyngeal carcinoma.
  -  Prior systemic treatment for metastatic and/or recurrent SCCHN
  -  Prior cisplatin containing induction chemotherapy followed by cisplatin containing chemoradiotherapy
  -  Prior anti-EGFr (Epidermal growth factor receptor) antibody therapy or treatment with small molecule EGFr inhibitors
  -  Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) less than or equal to 1 year prior to randomization. History of interstitial lung disease (eg, pneumonitis or pulmonary fibrosis) or evidence of interstitial lung disease on baseline chest computerized tomography (CT) scan.
  -  Symptomatic peripheral neuropathy grade ≥ 2 based on the CTCAE v3.0
  -  Grade ≥ 3 hearing loss based on the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 Auditory/Ear (Hearing [without monitoring program])

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

Clinical trial: Regenecare® Wound Gel in Treating Rash in Patients Receiving Cetuximab or Other Epidermal Growth Factor Receptor Inhibitor Therapy for Cancer

Summary: RATIONALE: Regenecare® wound gel may help relieve pain and itching in patients who develop an acne-like rash while undergoing treatment with cetuximab or another epidermal growth factor receptor inhibitor for cancer.
  PURPOSE: This clinical trial is studying how well Regenecare® wound gel works in treating rash in patients receiving cetuximab or another epidermal growth factor receptor inhibitor therapy for cancer.

Detailed description: OBJECTIVES:
  Primary
  -  Determine the efficacy of Regenecare® wound gel in alleviating pain and itching in patients who develop an acneiform rash while undergoing treatment with cetuximab or other EGFR inhibitor therapy for cancer.
  Secondary
  -  Determine the efficacy of this drug in reducing the severity of rash in these patients.
  -  Determine the efficacy of this drug in reducing the redness and appearance of the rash in these patients.
  -  Determine the tolerability of this drug in these patients.
  OUTLINE: This is a prospective study.
  -  Observation: Patients undergo evaluation by full-face photography prior to development of skin rash (baseline). While undergoing concurrent cancer therapy, patients self-monitor for the appearance of an acneiform rash. Upon initial onset of rash, patients proceed to treatment.
  -  Treatment: Patients apply topical Regenecare® wound gel to the face ≥ 4 times daily. Treatment continues for 4 weeks in the absence of unacceptable toxicity.
  Patients are evaluated weekly by facial examination, full-face photography, and patient satisfaction questionnaires.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of cancer
  -  Starting treatment with cetuximab or other EGFR inhibitor (e.g., erlotinib hydrochloride) on another clinical trial
  PATIENT CHARACTERISTICS:
  -  Not pregnant or nursing
  -  No known history of hypersensitivity to amine-type local anesthetics or to other components of MPM Regenecare® wound gel
  -  No other concurrent, serious skin disorders (i.e., scleroderma or psoriasis) that would interfere with assessment of EGFR inhibitor-induced rash
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics
  -  No other concurrent topical facial creams or lotions

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

Clinical trial: Studying Genes for Barrett's Esophagus in Brothers and Sisters

Summary: RATIONALE: Learning about how often heartburn and other risk factors occur in brothers and sisters and other family members of patients with Barrett's esophagus may help identify other individuals at risk and identify genes for Barrett's esophagus.
  PURPOSE: This clinical trial is studying genes for Barrett's esophagus in brothers and sisters.

Detailed description: OBJECTIVES:
  Primary
  -  To investigate the familial incidence of heartburn and Barrett's esophagus in first and second degree relatives of patients with Barrett's esophagus in the United Kingdom.
  -  To determine susceptibility genes for Barrett's esophagus in affected sibling pairs.
  -  To examine gene-environment interactions, such as smoking, alcohol, and Helicobacter pylori status, on familial susceptibility to heartburn and Barrett's esophagus.
  Secondary
  -  To compare the mortality from esophageal adenocarcinoma in family members with heartburn and Barrett's esophagus with deaths from other causes.
  OUTLINE: This is a multicenter study.
  Patients complete a family history questionnaire. Epidemiological data is also collected about environmental exposures, such as smoking and alcohol history. Any siblings or other living family members affected by heartburn identified from this survey are then contacted to validate their symptoms/diagnoses and to collect other relevant epidemiological data. Family members with heartburn are offered a screening endoscopy for the presence of Barrett's esophagus. In the absence of an endoscopy, a symptom nomogram predictive for the presence of Barrett's esophagus is used.
  Patients and their siblings, as well as any other willing family member (affected or non-affected) are asked to have a blood sample (EDTA tube for genetic analysis and a serum sample for Helicobacter pylori status) taken by their physician. Genomic DNA is extracted from lymphocytes and a genome-wide scan is performed using a standard marker set. A computer program is used to verify sibling relationships. Individuals not found to be full siblings are excluded from subsequent analyses. Maximum likelihood score (MLS) and the nonparametric linkage score (NPL) is used to estimate the degree of linkage.
  All study participants are flagged with the National Health Service (NHS) Central Register to ascertain the future mortality from esophageal adenocarcinoma compared with deaths from other causes.
  PROJECTED ACCRUAL: A total of 200 sibling pairs will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Sibling pairs will be recruited either from the United Kingdom National Barrett's Oesophagus Registry (UKBOR) of patients with Barrett's esophagus from 37 centers OR from National Health Service hospitals
  PATIENT CHARACTERISTICS:
  -  Not specified
  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: p53-Adjusted Neoadjuvant Chemotherapy for Potentially Resectable Esophageal Cancer

Summary: Study Hypothesis:
  PANCHO is a prospective randomized, predictive marker study, evaluating the interaction between the potential predictive marker 'p53 genotype' and response to induction chemotherapy in patients with esophageal cancer considered resectable.
  170 patients with measurable disease will be enrolled in this study. After testing the marker genotype (two genotypes: p53 normal or p53 mutant) patients will be stratified according to histological subtype only (adeno- or squamous cell carcinoma) and will be randomly assigned to receive 3 cycles of either 5-fluorouracil (5FU)/cisplatin or docetaxel monotherapy as neoadjuvant therapy. All patients will be rendered to subsequent surgery in order to assess both clinical and pathohistological response.

Detailed description: PANCHO will test the hypothesis that p53 genotype is predictive for response to chemotherapy. The study uses the marker by treatment interaction design. In this design, we assume that the status of the marker splits the whole population into two distinct groups (p53 normal versus p53 mutant).
  Patients in each marker group are randomly assigned to two different treatments, and planned statistical analysis is to test whether one treatment is superior to the other within each marker group separately.
  The marker information but not the treatment is blinded to the patient and the investigators.

Eligibility: Inclusion Criteria:
  -  Histological verification of esophageal cancer
  -  Presence of T2,T3,T4 or any N1 (except M1)
  -  Clinically measurable lesions according to RECIST criteria
  -  Males and females, age >18 to 75 or older with WHO performance status 1
  -  No prior tumor therapy for esophageal cancer
  -  No other malignancy in history within 5 years before evaluation
  -  Performance status of 0-2 on ECOG scale
  -  Medical fitness (adequate for possible esophageal resection, adequate organ function: see protocol)
  -  Signed informed consent
  -  Males and females with reproductive potential must use an approved contraceptive method. Females with childbearing potential must have a negative serum pregnancy test within 7 days prior to study enrollment.
  Exclusion Criteria:
  -  Inoperability (technical or functional)
  -  Clinical stage cT1N0, any M1
  -  Treatment with any of the investigational drugs within the last 6 months
  -  Concurrent administration of any other tumor therapy
  -  Pregnancy, breast feeding
  -  Serious concomitant disorders that would compromise the safety of the patient or ability to complete the study
  -  Second primary malignancy that is clinically detectable at the time of consideration for study enrollment

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

Clinical trial: RCT on the Combined Modality Treatment of Squamous Cell Carcinoma of the Esophagus

Summary: The purpose of the study was to test a null hypothesis that a combined modality treatment of esophageal cancer with neoadjuvant chemotherapy or chemoradiotherapy is equivalent to surgery alone and what are the benefits from adding irradiation to chemotherapy in neoadjuvant treatment of esophageal cancer.

Detailed description: The choice of the most beneficial method of treatment in esophageal cancer remains controversial and is the subject of vigorous debate. Surgery is still regarded as the principle modality among treatment strategies, with longterm survival achieved mainly in less advanced cases. More advanced cases, diagnosed more frequently, are more problematic in selection of the optimal therapeutic method. One of the options for improving treatment outcome in patients with advanced esophageal cancer is combined modality treatment with chemo- and chemoradiotherapy. Currently available RCTs have tested preoperative chemotherapy or chemoradiotherapy separately in comparison to surgery alone. Moreover, we do not know from these trials what is the added value of irradiation in a combined modality therapy over a preoperative chemotherapy. Another drawback of available RCTs is combining 2 different biological cancer entities: adenocarcinoma and squamous cell carcinoma of the esophagus as well as carcinoma of the esophagus and gastro-esophageal junction. That were the reasons for designing our trial testing 3 principal modes of esophageal cancer therapy: surgery vs. chemotherapy + surgery vs. chemoradiotherapy + surgery on homogenous population of esophageal cancer patients with single pathological type - squamous cell carcinoma affecting thoracic esophagus.

Eligibility: Inclusion Criteria:
  -  Informed consent
  -  Histopathologically proven, clinically stage II-III (cTNM according to AJCC/UICC classification), primary squamous cell carcinoma of the thoracic esophagus
  -  Patients' age above 18 years
  -  General condition with Karnofsky performance status of >70
  -  Circulatory and pulmonary capacity at normal range (FEV1 >60%; FVC >60%, NYHA I-II, cardiac output >40%)
  -  Normal function of the bone marrow (RBC >3,5 T/l; PLT >100 G/l)
  -  Normal renal (creatinine <1.5 of the upper limit) and liver (AST or ALT <2,5 of the upper limit or bilirubin <1,5 of the upper limit) function
  Exclusion Criteria:
  -  Metastatic disease
  -  Synchronous malignancy
  -  History of other cancer within 5 years prior to esophageal cancer treatment
  -  History of allergic reaction to cisplatin of 5-fluorouracil
  -  Systemic infection
  -  Pregnancy or female patients in childbearing age without proper contraceptives.

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

Clinical trial: Safety Study of Multiple Peptide Vaccine to Esophageal Cancer

Summary: This is a phase 1 study of multiple peptide vaccine therapy and GM-CSF in treating patients with esophageal cancer.

Detailed description: LY6K (lymphocyte antigen 6 complex, locus K) was identified as a new target of tumor associated antigen using cDNA microarray technologies combined with the expression profiles of normal and cancer tissues. On the other hand, anti-angiogenic therapy is now considered to be one of promising approaches to treat of cancer. In this clinical trial, we evaluate the safety and immune responses of multiple peptide cocktail including LY6K and vascular endothelial growth factor receptor 1 (VEGFR1) and vascular endothelial growth factor receptor 2 (VEGFR2) together with IFA and GM-CSF as immunoadjuvants in patients who had LY6K expressed primary esophageal cancer. Toxicity profiles will be monitored, and antigen specific T cell responses will be described.

Eligibility: Inclusion Criteria:
  1. Patients must have metastatic disease of esophageal cancer, and treatment has failed, or in the situation where effective therapy is not available, or has been refused due to severe adverse effects of chemotherapy
  2. WHO performance status of 0 to 2
  3. Age ≥ 20 years, ≤75 years
  4. Chemotherapy, any type of radiation therapy, or immunotherapy within 4 weeks before study entry
  5. Expected survival of at least 3 months
  6. WBC≥ 2,000/mm³ Platelet count ≥ 100,000/mm³ Total bilirubin ≤ 1.5 x the institutional normal upper limits AST, ALT, ALP ≤ 2.5 x the institutional normal upper limits Creatinine ≤ 1.5 x the institutional normal upper limits
  7. Patients must be HLA-A2402
  8. Primary lesion of esophageal cancer must express LY6K
  9. 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. Serious infections requiring antibiotics
  4. Patient with peptic ulcer disease
  5. Previous history of intestinal perforation
  6. bleeding disorders (INR ≥ 1.5)
  7. Necessity of drug-mediated inhibition with platelet function
  8. Taking antithrombogenic agents within 10 days
  9. Serious hypertension
  10. Previous history of arterial thrombosis or venous thrombosis
  11. Other malignancy within 5 years prior to entry into the study, except for treated non-melanoma skin cancer and cervical carcinoma in situ
  12. Clinically significant heart disease or previous history of myocardial infarction within the past 12 months
  13. Concomitant treatment with steroids or immunosuppressing agent
  14. Disease to the central nervous system
  15. 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: Erlotinib in Treating Patients With Barrett Esophagus

Summary: RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. Erlotinib may keep esophageal cancer from forming in patients with Barrett esophagus by blocking some of the enzymes needed for cell growth.
  PURPOSE: This phase II trial is studying how well erlotinib works in treating patients with Barrett esophagus.

Detailed description: OBJECTIVES:
  Primary
  -  To determine if erlotinib hydrochloride can be used as a chemopreventive agent that can cause histologic regression of Barrett esophagus in patients at high risk of developing esophageal cancer associated with high-grade dysplasia.
  Secondary
  -  To assess whether erlotinib hydrochloride can cause molecular alterations in EGFR, phospho-EGFR, cyclin D1, cdc2, p16, p53, PCNA, COX-2, and ploidy in Barrett esophagus with high-grade dysplasia.
  -  To establish surrogate markers of chemoprevention in Barrett esophagus with high-grade dysplasia.
  -  To validate the histologic scoring of Barrett dysplasia developed by our group.
  -  To evaluate toxicities associated with the use of erlotinib hydrochloride in patients with Barrett esophagus associated with high-grade dysplasia.
  OUTLINE: Patients receive oral erlotinib hydrochloride once daily for 3 months. Patients showing no evidence of progression to cancer by esophagogastroduodenoscopy (EGD) with biopsy receive an additional 3 months of treatment. All patients then undergo repeat EGD, biopsy, and determination of molecular markers (i.e., EGFR, phospho-EGFR, cyclin D1, cdc2, p16, p53, PCNA, COX-2, and ploidy).
  After completion of study treatment, patients are followed for 30 days.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of Barrett esophagus with high-grade dysplasia
  -  Refused surgery or other localized therapy for high-grade dysplasia
  -  No invasive esophageal carcinoma
  PATIENT CHARACTERISTICS:
  -  ANC ≥ 1,500/mm³
  -  Platelet count ≥ 100,000/mm³
  -  Hemoglobin ≥ 10 g/dL
  -  Bilirubin normal
  -  AST and ALT < 3 times upper limit of normal (ULN)
  -  Alkaline phosphatase < 3 times ULN
  -  No uncontrolled medical condition
  -  Not pregnant or nursing
  -  Negative pregnancy test
  -  Fertile patients must use effective contraception during and for at least 1 week after completion of study treatment
  -  Able to swallow tablets or dissolved tablets
  -  No known hypersensitivity to erlotinib hydrochloride
  -  No symptoms suggestive of malignancy (e.g., weight loss or vomiting)
  -  No history of other malignancies
  -  No uncontrolled medical or psychiatric condition that would preclude treatment under this clinical trial
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics
  -  No prior exposure to erlotinib hydrochloride
  -  No concurrent antineoplastic or antitumor agents, including chemotherapy, radiotherapy, immunotherapy, or hormonal therapy
  -  No concurrent investigational agents

Relevance to patient case: definitely relevant