araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 54-year-old male with Gastric cancer. Genetic variant: PIK3CA (E545K). Other conditions: Depression.

Clinical trial: Trial of Adjuvant Chemotherapy for Gastric Cancer

Summary: This study is designed to evaluate the efficacy of the intraperitoneal chemotherapy with early mitomycin administration and adding cisplatin to prolonged treatment with doxifluridine compared to mitomycin plus doxifluridine in resected advanced gastric cancer.

Detailed description: Stomach cancer is the most common cancer in Korea and one of the major health problems worldwide. The most effective treatment for gastric cancer is curative surgical resection of primary tumor. However, a substantial number of patients eventually die of recurrences after curative resection. A number of randomized trials investigating the role of adjuvant chemotherapy have been conducted. However, the efficacy of adjuvant chemotherapy is still controversial and varied between Western and Asian trials. Meta-analysis of Western trials didn't demonstrate the benefit of adjuvant chemotherapy after curative resection. Conversely, some Asian studies have demonstrated the efficacy of adjuvant chemotherapy after curative resection. In a previous study, mitomycin plus tegafur prolonged the survival in resected gastric cancer compared to no treatment.
  This study is designed to evaluate the efficacy of the intraperitoneal chemotherapy with early mitomycin administration and adding cisplatin to prolonged treatment with doxifluridine compared to mitomycin plus doxifluridine.

Eligibility: Inclusion Criteria:
  -  Pathologically proven gastric adenocarcinoma
  -  Grossly serosa invasion of primary tumor is suspicious
  -  Curative resection was done
  -  Stage II, IIIA, IIIB, IV (including T4, lesions or N3, but excluding M1 lymph node metastasis)
  -  Age: 18-69 years old
  -  Performance status: Eastern Cooperative Oncology Group (ECOG) 0-2
  -  Adequate bone marrow function (white blood cell counts ≥ 4,000/ul, platelet count ≥ 100,000/ul, hemoglobin ≥ 10 g/dl)
  -  Adequate renal function (serum creatinine≤ 1.5)
  -  Adequate liver function (serum bilirubin ≤1.5 mg/dl, aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 3 x normal upper limit)
  -  Written informed consent was signed by the patient
  Exclusion Criteria:
  -  Previous chemotherapy or radiotherapy
  -  Active ongoing infection which antibiotic treatment is needed
  -  Pregnant or lactating women
  -  Psychosis or convulsion disorder
  -  Ascites in preoperative abdomen computed tomography (CT)
  -  Systemic disease which interfere the administration of chemotherapy
  -  Postoperative pathologic stage IA, IB
  -  Postoperative pathology indicates that resection margin is involved
  -  Previous history of other malignancy except cured non-malignant skin cancer and uterine cervical cancer in situ

Relevance to patient case: not relevant
Patient case: 54-year-old male with Gastric cancer. Genetic variant: PIK3CA (E545K). Other conditions: Depression.

Clinical trial: Trial of Adjuvant Chemotherapy for Gastric Cancer

Summary: This is a phase III randomized study designed to evaluate the efficacy of mitomycin, doxifluridine, and cisplatin compared to mitomycin and doxifluridine.

Detailed description: Stomach cancer is the most common cancer in Korea and one of the major health problems worldwide. The most effective treatment for gastric cancer is curative surgical resection of primary tumor. However, a substantial number of patients eventually die of recurrences after curative resection. A number of randomized trials investigating the role of adjuvant chemotherapy have been conducted. However, the efficacy of adjuvant chemotherapy is still controversial and varied between Western and Asian trials. Meta-analysis of Western trials didn't demonstrate the benefit of adjuvant chemotherapy after curative resection. Conversely, some Asian studies have demonstrated the efficacy of adjuvant chemotherapy after curative resection. In a previous study, mitomycin plus tegafur prolonged the survival in resected gastric cancer compared to no treatment.
  This study is designed to evaluate the efficacy of mitomycin, cisplatin and prolonged treatment with doxifluridine compared to mitomycin plus doxifluridine.

Eligibility: Inclusion Criteria:
  -  Pathologically proven gastric adenocarcinoma
  -  Curative resection was done
  -  stage II, IIIA, IIIB, IV (including T4, lesions or N3, but excluding M1 lymph node metastasis)
  -  age: 18-69 years old
  -  Performance status: ECOG 0-2
  -  Adequate bone marrow function (WBC ≥ 4,000/ul, platelet count ≥ 100,000/ul, hemoglobin ≥ 10 g/dl)
  -  Adequate renal function (serum creatinine≤ 1.5)
  -  Adequate liver function (serum bilirubin ≤1.5 mg/dl, AST/ALT ≤ 3 x normal upper limit)
  -  Written informed consent was signed by the patient
  Exclusion Criteria:
  -  Previous chemotherapy or radiotherapy
  -  Active ongoing infection which antibiotic treatment is needed
  -  Pregnant or lactating women
  -  Psychosis or convulsion disorder
  -  Ascites in preoperative abdomen CT
  -  Systemic disease which interfere the administration of chemotherapy
  -  Previous history of other malignancy except cured non-malignant skin cancer and uterine cervical cancer in situ

Relevance to patient case: not relevant
Patient case: 54-year-old male with Gastric cancer. Genetic variant: PIK3CA (E545K). Other conditions: Depression.

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: 54-year-old male with Gastric cancer. Genetic variant: PIK3CA (E545K). Other conditions: Depression.

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: not relevant
Patient case: 54-year-old male with Gastric cancer. Genetic variant: PIK3CA (E545K). Other conditions: Depression.

Clinical trial: Cetuximab in Treating Patients With Ménétrier Disease at High Risk of Developing Stomach Cancer

Summary: RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.
  PURPOSE: This clinical trial is studying how well cetuximab works in treating patients with Ménétrier disease at high risk of developing stomach cancer.

Detailed description: OBJECTIVES:
  -  Evaluate clinical and biochemical parameter response in patients with Ménétrier disease at high risk of developing gastric cancer treated with cetuximab.
  OUTLINE: This is a non-randomized study.
  Patients receive cetuximab IV on days 1, 8, 15, and 22. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.
  Patients complete a quality of life questionnaire at baseline and during week 4.
  PROJECTED ACCRUAL: A total of 10 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically confirmed Ménétrier disease
  -  Symptomatic disease, including gastrointestinal symptoms which interfere with daily life
  -  Patient is considering surgery
  -  Must have failed medical therapy that was given for 6 months
  -  No Helicobacter pylori infection
  PATIENT CHARACTERISTICS:
  -  Not pregnant or nursing
  -  Negative pregnancy test
  -  Fertile patients must use effective contraception
  -  No NYHA class III-IV cardiovascular disease
  -  No clinically unstable pulmonary disease
  -  No chronic disease requiring ongoing therapy for stabilization, including any of the following:
  -  Uncontrolled diabetes mellitus
  -  Malignancy
  -  Thyroid disease
  -  Hypertension
  -  Active infections requiring systemic antibiotics, antivirals, or antifungals
  -  Uncontrolled seizure disorder
  -  Active neurological disease
  -  No unstable coagulation disorders (e.g., hemorrhagic diatheses or active bleeding disorders) that require medical management
  PRIOR CONCURRENT THERAPY:
  -  Not specified

Relevance to patient case: not relevant
Patient case: 54-year-old male with Gastric cancer. Genetic variant: PIK3CA (E545K). Other conditions: Depression.

Clinical trial: Efficacy and Safety of Everolimus (RAD001) in Patients With Advanced Gastric Cancer

Summary: The purpose of this study is to assess the efficacy and safety of everolimus 10mg daily in patients with advanced gastric carcinoma (inoperable, recurrent or metastatic gastric cancer) whose cancer has progressed despite prior treatment.


Eligibility: Inclusion criteria:
  -  Histological proven gastric adenocarcinoma
  -  Progressive disease during/ after prior treatment
  -  Treated with 1 or 2 chemotherapy regimen for advanced disease
  -  At least one measurable lesion by RECIST criteria
  -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  Exclusion criteria:
  -  History of another primary malignancy within 3 years
  -  Treated with 3 or more regimens for advanced gastric cancer
  -  Chronic treatment with steroids or another immunosuppressive agent
  -  A known history of HIV or hepatitis B seropositive, or active hepatitis C infection
  -  Patients with active, bleeding diathesis
  Other protocol-defined inclusion/exclusion criteria may apply

Relevance to patient case: not relevant
Patient case: 54-year-old male with Gastric cancer. Genetic variant: PIK3CA (E545K). Other conditions: Depression.

Clinical trial: Bioresorbable Membrane to Reduce Postoperative Small Bowel Obstruction

Summary: To assess whether the use of Seprafilm reduces the rate of small bowel obstruction in patients who underwent surgery for gastric cancer.

Detailed description: Patients with gastric cancer who were scheduled to undergo gastrectomy were randomly assigned to a sodium hyaluronate-based bioresorbable membrane (Seprafilm) group or to a control group. Before closing the abdominal incision, two sheets of Seprafilm membrane were applied to the surface of the small intestine under the middle abdominal wound in the Seprafilm group. The primary end point was the incidence of bowel obstruction. Secondary end points were intraoperative and postoperative morbidity and mortality.

Eligibility: Inclusion Criteria:
  -  Clinical diagnosis of gastric cancer
  -  Operable
  Exclusion Criteria:
  -  Withdrew consent
  -  Pregnant
  -  Ascites
  -  Distant metastasis
  -  Liver dysfunction (serum total bilirubin >2.0 mg/dL)
  -  Renal failure (serum creatinine >1.5 mg/dL)
  -  A past history of small bowel obstruction.

Relevance to patient case: not relevant
Patient case: 54-year-old male with Gastric cancer. Genetic variant: PIK3CA (E545K). Other conditions: Depression.

Clinical trial: Comparative Efficacy & Safety Study of Esomeprazole Versus Placebo for the Prevention of Gastric and Duodenal Ulcers With NSAID

Summary: The purpose of this study is to assess the efficacy of esomeprazole (D961H) 20 mg versus placebo once daily for up to 24 weeks of treatment involving patients with a history of gastric and/or duodenal ulcers receiving daily nonsteroidal anti-inflammatory drug (NSAID) therapy by evaluating presence or absence of gastric and/or duodenal ulcers throughout the treatment period (24 weeks) in terms of efficacy on prevention of gastric and/or duodenal ulcers


Eligibility: Inclusion Criteria:
  -  Medical history of gastric and/or duodenal ulcer
  -  A diagnosis of a chronic condition (rheumatoid arthritis, osteoarthritis, lumbago,etc) that requires daily NSAID use,at least 20 years of age
  Exclusion Criteria:
  -  Having gastric or duodenal ulcer in active or healing stage according to the Sakita/Miwa classification
  -  History of esophageal, gastric or duodenal surgery
  -  Having severe liver disease or chronic renal disease

Relevance to patient case: not relevant
Patient case: 54-year-old male with Gastric cancer. Genetic variant: PIK3CA (E545K). Other conditions: Depression.

Clinical trial: Capecitabine and Cisplatin (XP)+Sorafenib in Advanced Gastric Cancer (AGC)

Summary: There is strong scientific rationale for exploring the role of sorafenib with capecitabine and cisplatin (XP) in AGC. XP is a new standard of care in AGC and sorafenib is a novel signal transduction inhibitor that prevents tumor cell proliferation and angiogenesis through blockade of the Raf/MEK/ERK pathway at the level of Raf kinase and the receptor tyrosine kinases VEGF-R2 and PDGFR-beta.


Eligibility: Inclusion Criteria:
  -  Having given signed written informed consent
  -  Unresectable advanced gastric adenocarcinoma, initially diagnosed or recurred
  -  No history of chemotherapy or radiation
  -  Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST)
  -  Age 18-75 years
  -  Estimated life expectancy of more than 3 months
  -  Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  -  Adequate bone marrow function (absolute neutrophil count > 1,500/µL, platelets > 100,000/µL, hemoglobin > 8g/dl),
  -  Adequate kidney function (creatinine clearance > 60 ml/min)
  -  Adequate liver function (bilirubin < 2.0 mg/dL, transaminases levels < 3 times the upper normal limit [5 times for patients with liver metastasis])
  Exclusion Criteria:
  -  Past or concurrent history of neoplasm other than gastric adenocarcinoma, except for curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix uteri
  -  Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study treatment start
  -  Presence of central nervous system metastasis
  -  Obvious peritoneal seeding or bowel obstruction
  -  Evidence of serious gastrointestinal bleeding
  -  Peripheral neuropathy (National Cancer Institute Common Terminology Criteria for Adverse Event version 3.0 > Grade I)
  -  History of significant neurologic or psychiatric disorders
  -  Pregnant or lactating women, women of childbearing potential not employing adequate contraception
  -  Other serious illness or medical conditions
  -  Known allergy to study drugs

Relevance to patient case: not relevant
Patient case: 54-year-old male with Gastric cancer. Genetic variant: PIK3CA (E545K). Other conditions: Depression.

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