araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 60-year-old female with gastric cancer; genetic feature: EGFR

Clinical trial: Perioperative Chemoradiotherapy for Potentially Resectable Gastric Cancer

Summary: Rationale: Adjuvant chemoradiation considered as standard of care after curative surgery for adenocarcinoma of stomach and gastroesophageal cancer. Preoperative chemotherapy in the in locally advanced gastric cancer results in significant tumoral downstaging with improved rate of curative resections.
  Purpose: To evaluate feasibility and safety of combination of preoperative chemotherapy and postoperative chemoradiation for locally advanced adenocarcinoma of stomach and gastroesophageal cancer


Eligibility: Inclusion Criteria:
  1. Histologically confirmed primary adenocarcinoma, poorly differentiated carcinoma, or carcinoma not otherwise specified, of stomach or gastro-esophageal junction.
  2. T2-4 N0-3 M0. T1 tumors are eligible if T1N1-3
  3. Disease must be clinically limited to the stomach or GEJ.
  4. Pre-treatment Port-a-Cath insertion obligatory
  5. No prior chemotherapy.
  6. No prior radiotherapy.
  7. Patients must be surgical candidates as determined by the treating surgeon.
  8. Adequate organ function defined as:
  9. Patients must have an ECOG Performance Status < 1.
  10. Patients must be able to sign the informed consent document.
  Exclusion Criteria:
  1. Tis (in-situ carcinoma) and tumors determined to be TIN0 following endoscopy, endoscopic ultrasound and CT scanning.
  2. Patients with primary carcinomas of the esophagus.
  3. Prior chest or upper abdomen radiotherapy, prior systemic chemotherapy within the past 5 years, or prior esophageal or gastric surgery.
  4. Patients with evidence of metastatic disease are not eligible.
  5. New York Heart Association Class III or IV heart disease.
  6. Severe co-morbid conditions or nonmalignant illness whose control may be jeopardized by complications of the study treatment.
  7. Pregnant or lactating women or men unable or unwilling to practice contraception are excluded.
  8. Any history of prior malignancy (other than non-melanoma skin cancer, in-situ cervical cancer, or superficial transitional cell bladder cancer).
  9. Clinically significant hearing loss.
  10. Patients with a history of seizure disorder who are receiving phenytoin, phenobarbital, or other antiepileptic medication.
  11. Patients who cannot fully comprehend the therapeutic implications of the protocol or comply with its requirements.
  12. Patients with any medical or psychiatric condition or disease which, in the investigator’s judgment, would make the patient inappropriate for entry into this study

Relevance to patient case: not relevant
Patient case: 60-year-old female with gastric cancer; genetic feature: EGFR

Clinical trial: A Study of Cetuximab(Erbitux) With Cisplatin and Capecitabine(Xeloda)as 1st Line Treatment in the Advanced Gastric Cancer

Summary: The purpose of this study is to investigate whether cetuximab (Erbitux®) with cisplatin and capecitabine (Xeloda) as 1st line treatment in the advanced gastric cancer is effective.

Detailed description: Gastric cancer remains one of the major causes of cancer deaths around the world, especially in Asia. Previous study of ML17032 has proved that XP(capecitabine plus cisplatin)is effective in advanced gastric cancer, with the overall response rate of 41%, the median PFS of 5.6 month. Recently, the EGFR monoclonal antibody of cetuximab has shown to be successful in treating advanced colorectal cancer with or without chemotherapy. Since EGFR also express in gastric cancer, A single arm, open, multicenter phase II study of cetuximab in combination with cisplatin and capecitabine as first line treatment in patient with advanced gastric cancer.If applicable, the value of mutations in k-ras, b-raf, P53, and EGFR copy number to predict the clinical response to cetuximab in advanced gastric cancer patients will also be accessed.Tumor tissue from study patients will be checked for k-ras, b-raf, and P53 mutation by sequencing and for EGFR copy number by chromogenic in situ hybridization. DNA will be extracted from paraffin-embedded samples.

Eligibility: Inclusion Criteria:
  -  Having signed informed consent
  -  Age 18 to 75 years old
  -  Histologically confirmed gastric adenocarcinoma
  -  Unresectable recurrent or metastatic disease
  -  Previous neo-adjuvant or adjuvant treatment for gastric cancer, if applicable, more than 12 months
  -  Measurable disease according to the RECIST criteria
  -  Karnofsky performance status ≥60
  -  Life expectancy of ≥2 month
  -  No prior radiotherapy except radiotherapy at non-target lesion of the study more than 4 weeks
  -  ALT and AST<2.5 times ULN (≤5 times ULN in patients with liver metastases)
  -  Serum albumin level ≥3.0g/dL
  -  Serum AKP < 2.5 times ULN
  -  Serum creatinine <1.5mg/dL
  -  Bilirubin level < 1.5mg/dL
  -  Serum creatinine <1.5 times ULN
  -  WBC>3,000/mm3, absolute neutrophil count ≥2000/mm3, platelet>100,000/mm3, Hb>9g/dl
  Exclusion Criteria:
  -  Brain metastasis (known or suspected)
  -  Previous systemic therapy for metastatic gastric cancer
  -  Inability to take oral medication
  -  Previous EGFR pathway-targeting therapy
  -  Surgery (excluding diagnostic biopsy) within 4 weeks prior to study entry
  -  Heart failure, coronary artery disease, myocardial infarction within the last 6 months
  -  Known allergy to any study treatment
  -  Pregnancy or lactation period
  -  Any investigational agent within the past 28 days
  -  Other previous malignancy within 5 year, except non-melanoma skin cancer
  -  Previous adjuvant therapy with capecitabine+platinum
  -  Pre-existing neuropathy>grade 1
  -  Legal incapacity

Relevance to patient case: definitely relevant
Patient case: 60-year-old female with gastric cancer; genetic feature: EGFR

Clinical trial: Effects of Epidermal Growth Factor Receptor Inhibitor Therapy in the Skin of Cancer Patients

Summary: RATIONALE: Studying samples of tissue and blood in the laboratory from patients with cancer receiving epidermal growth factor receptor (EGFR) inhibitors may help doctors understand the effects of EGFR inhibitor therapy in the skin.
  PURPOSE: This laboratory study is looking at the effects of EGFR inhibitors in the skin of cancer patients.

Detailed description: OBJECTIVES:
  -  Determine the effects of EGFR inhibitors on the EGFR pathway in the skin of cancer patients prior to and after receiving EGFR inhibitors (i.e., tyrosine kinase inhibitors and monoclonal antibodies).
  -  Compare the effects of EGFR tyrosine kinase inhibitors vs monoclonal antibodies on the EGFR pathway in the skin of these patients.
  -  Compare changes in the EGFR pathway with grade of rash in these patients.
  -  Compare changes in EGFR pathway effectors in the skin with serum TGFα levels in these patients.
  OUTLINE: This is a pilot study.
  Patients undergo skin punch biopsies and blood sample collection at baseline, within 1 week of developing skin rash, and 6 weeks after beginning treatment. Samples are analyzed by immunohistochemistry and western blot for phosphorylated MAP kinase, AKT, and EGF levels and TGFα levels. Patients also complete diagrams to indicate locations of the rash once weekly during the first 6 weeks of treatment.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of a malignancy for which therapy on or off a clinical trial with an inhibitor of the EGFR pathway is under consideration
  -  The therapy under consideration may be monotherapy or combined with other therapies as long as other therapies do not typically cause a rash
  PATIENT CHARACTERISTICS:
  -  INR ≤ 3.0 (for patients receiving concurrent warfarin)
  -  No severe underlying skin disorder (e.g., toxic epidermal necrolysis or severe dermatitis) that would preclude study treatment
  -  No bleeding diatheses that would preclude safe biopsy
  -  No allergy to lidocaine or similar local anesthetics
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics

Relevance to patient case: possibly relevant
Patient case: 60-year-old female with gastric cancer; genetic feature: EGFR

Clinical trial: Early Onset and Familial Gastric Cancer Registry

Summary: The purpose of this study is to establish a gastric cancer registry. A registry is a database of information. With the registry, we can learn more about the genetic causes of gastric cancer in order to develop better methods of early diagnosis, prevention, and treatment of gastric cancers. As part of this study, you will be asked to join a registry of families who are affected with various forms of gastric cancer. These registries are important because they may help physicians better manage gastric cancer now and in the future. Participating in the Early Onset and Familial Gastric Cancer Registry can also be educational for families, since it will provide important information to patients, families, and physicians. All of this will help to further our understanding of genetic causes of gastric cancer and eventually, help determine better ways to diagnose, treat, and survey patients with gastric cancer and people who may have a higher risk for gastric cancer.


Eligibility: Inclusion Criteria:
  Patient/Relative Cohort:
  Must meet one or more criteria below:
  1. A person with a diagnosis of gastric or gastroesophageal junction (GEJ) adenocarcinoma confirmed at the treating institution.
  2. A person without gastric or GEJ adenocarcinoma who has or had a first degree relative eligible for a High Risk Genetic sub-group (EOGC/FGC).
  1. Early Onset Gastric Cancer - diagnosis of gastric cancer before the age of 50 without a family history of the disease.
  2. Familial Gastric Cancer - having a family history of gastric cancer as defined as one first degree relative or 2 second degree relatives.
  3. A person without gastric or GEJ adenocarcinoma who has a personal family history of a genetic mutation associated with the development of gastric or GEJ adenocarcinoma (i.e. family history of CDH1 mutation).
  II. Must be willing to provide a blood sample for germline DNA. These individuals will sign the "Patient/Relative Consent". Following enrollment, we will assign individuals to the appropriate High Genetic Risk or Low Genetic Risk groups based on the age of diagnosis and their family history.
  Subject Exclusion Criteria
  Patients are ineligible for the study if they:
  -  Have any condition, which in the opinion of the primary MSK clinician or investigators precludes their ability to provide informed consent.
  -  Relatives of patients that are not eligible for the High Genetic Risk Cohorts who are less than 18 years of age are excluded.
  -  Relatives of patients eligible for the High Genetic Risk Cohorts who do not have a proband available to join the study are excluded. (Unless there is a known CDH1 mutation in the family).

Relevance to patient case: not relevant
Patient case: 60-year-old female with gastric 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: not relevant
Patient case: 60-year-old female with gastric cancer; genetic feature: EGFR

Clinical trial: Histocompatibility Leukocyte Antigen (HLA)-A*0201 Restricted Peptide Vaccine Therapy in Patients With Gastric 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 gastric 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. The patients will also receive oral chemotherapy (S-1) simultaneously. 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 gastric 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 to receive oral TS-1 therapy
  -  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
  -  History of allergy to Tegaful, Gimeracil and/or Oteracil
  -  Decision of unsuitableness by principal investigator or physician-in-charge

Relevance to patient case: not relevant
Patient case: 60-year-old female with gastric cancer; genetic feature: EGFR

Clinical trial: Histological Characterization and Differentiation of Rash From Other Epidermal Growth Factor Receptor (EGFR) Inhibitors

Summary: The purpose of this study is to characterize the microscopic findings of skin rash associated with the use of chemotherapeutic anticancer agents known as epidermal growth factor inhibitors (EGFRIs).

Detailed description: Epidermal growth factor (EGF) and its receptor, the EGFR, are known to be key drivers in cellular proliferation and survival. Malignant tumors result from uncontrolled cell proliferation. The use of drugs which target the EGF receptor has offered patients with non-small cell lung cancer, pancreatic cancer, head and neck cancer, and colorectal cancer additional targeted anti-cancer therapy in addition to their chemotherapeutic regimens. As a result of increased use of these EGFR inhibitors, adverse events have emerged involving the skin, hair, nails and eyes. While the EGFR inhibitors block the signal transduction that interfere with cellular proliferation and survival of cancerous cells, they also affect the normal EGF function in the skin (papulopustular rash), hair, and nails. In this study, we seek to histologically characterize the papulopustular rash in patients who have been treated with lapatinib and compare our findings with those associated with three other EGFRIs, cetuximab, erlotinib and panitumumab.

Eligibility: Inclusion Criteria:
  -  Patients treated with lapatinib who developed skin toxicities and were biopsied.
  -  Patients treated with erlotinib, cetuximab, or panitumumab who have been biopsied for skin rash.
  Exclusion Criteria:
  -  Patients who do not fit above criteria.

Relevance to patient case: not relevant
Patient case: 60-year-old female with gastric 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: possibly relevant
Patient case: 60-year-old female with gastric cancer; genetic feature: EGFR

Clinical trial: Antiangiogenic Factors in Gastric Cancer

Summary: Endogenous antiangiogenic factors are related with gastric cancer progression.

Detailed description: Gastric cancers have been known to secrete the proangiogenic cytokine VEGF in vitro and in vivo. Tumor VEGF expression is correlated with the severity of disease in patients with gastric cancer and some authors have suggested using circulating VEGF as a prognostic factor or tumor marker.In addition to producing proangiogenic cytokines, recent data demonstrate that tumors can produce antiangiogenic cytokine as well. It has been suggested that, in humans, the generation of antiangiogenic compounds in the presence of a primary tumor suppresses the growth of distant metastases. This phenomenon has been demonstrated in mice and in patients with clear cell renal cancer, breast cancer, and colorectal cancer. However, the presence of endogenous antiangiogenic cytokines in patients with gastric cancer has not been reported.

Eligibility: Inclusion Criteria:
  -  Histologic diagnosis of gastric adenocarcinoma
  -  No other forms of cancer therapy, such as chemotherapy or radiotherapy for at least 3 weeks before the enrollment in study
  -  Performance status of 0, 1, 2 on the ECOG criteria
  -  ASA class I, II
  -  Patient compliance that allow adequate follow up
  -  Informed consent from patient or patient's relative.
  Exclusion Criteria:
  -  Second primary malignancy
  -  EMR (Endoscopic mucosal resection) indication
  -  Laparoscopic gastrectomy
  -  Radiologic or clinical evidence of metastasis

Relevance to patient case: not relevant
Patient case: 60-year-old female with gastric cancer; genetic feature: EGFR

Clinical trial: Support for Increased Physical Activity (Stöd Till Aktivare Motion)

Summary: The purpose of this study is to improve and analyze the level of physical activity in immigrant women from the Middle East and Latin America living in Sweden. The investigators will also investigate if glucose, insulin, and lipid metabolism; stress-related hormone production; and subclinical inflammatory activity are affected by the intervention. The follow-up period is 2 years.


Eligibility: Inclusion Criteria:
  -  Female gender
  -  Age 25 through 64 years
  -  Physical inactivity
  -  BMI > 25
  -  Immigrant to Sweden from either the Middle East or Latin America
  Exclusion Criteria:
  -  Diabetes mellitus type I
  -  Ischemic heart disease
  -  Disability that interferes with the ability to participate in lifestyle-related physical activity

Relevance to patient case: not relevant
Patient case: 60-year-old female with gastric cancer; genetic feature: EGFR

Clinical trial: Proteiomic Fingerprints of Gastric Juice

Summary: No accurate, inexpensive and non-invasive test for gastric cancer screening is currently available. The investigators' recent study identified a1-antitrypsin and other proteins as potential biomarkers of gastric cancer in gastric juice. The aim of this study was to develop a novel non-invasive modality for detecting gastric cancer by measurement of biomarkers in gastric juice.

Detailed description: Patients and methods: The study consisted of two parts: (1) investigating the differences in gastric juice biomarker concentrations between gastric cancer patients and controls, and (2) screening gastric cancer using string test to obtain gastric juice followed by immunoassay for biomarker concentration.

Eligibility: Inclusion Criteria:
  -  healthy subjects and gastric cancer patients documented by endoscopy.
  Exclusion Criteria:
  -  the use of proton pump inhibitors or histamine-2 receptor antagonists within 4 weeks prior to the study
  -  coexistence of two kinds of gastroduodenal lesions
  -  coexistence of severe systemic diseases

Relevance to patient case: not relevant