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

Clinical trial: A Study of the Safety and Pharmacology Of PI3-Kinase Inhibitor GDC-0941 In Combination With Either Paclitaxel And Carboplatin (With or Without Bevacizumab) or Pemetrexed, Cisplatin, And Bevacizumab in Patients With Advanced Non-Small Cell Lung Cancer

Summary: This is an open-label, multicenter, Phase Ib dose-escalation study to assess the safety, tolerability, and pharmacokinetics of oral (PO) GDC-0941 administered with one of three planned regimens: Arm A: paclitaxel and carboplatin in bevacizumab-ineligible NSCLC patients, Arm B: paclitaxel, carboplatin, and bevacizumab in bevacizumab-eligible NSCLC patients and Arm C: pemetrexed, cisplatin, and bevacizumab in bevacizumab-eligible, non-squamous NSCLC patients.


Eligibility: Inclusion Criteria:
  -  Histologically or cytologically documented NSCLC with advanced disease (Stage IIIb not eligible for chemoradiotherapy or Stage IV or recurrent disease)
  -  Adequate organ function as assessed by laboratory tests
  -  Evaluable disease or disease measurable per Response Evaluation Criteria in Solid Tumors (RECIST)
  Exclusion Criteria:
  -  More than one anti-cancer regimen (chemotherapy or radiotherapy) for advanced NSCLC prior to initiation of study treatment
  -  Any adjuvant or neoadjuvant anti-cancer therapy within a specified timeframe prior to first study treatment
  -  History of Grade >= 3 fasting hyperglycemia or diabetes requiring regular medication
  -  Active autoimmune disease, active infection requiring IV antibiotics, or other current uncontrolled illness
  -  History of clinically significant cardiac or pulmonary dysfunction
  -  History of malabsorption syndrome or other condition that would interfere with enteral absorption
  -  Clinically significant history of liver disease
  -  Any condition requiring full-dose anticoagulants, such as warfarin, heparin, or thrombolytic agents
  -  Known brain metastases that are untreated, symptomatic, or require therapy
  -  Pregnancy, lactation, or breastfeeding

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

Clinical trial: Adjuvant Chemotherapy With Docetaxel, Capecitabine and Cisplatin in Patients With Advanced Gastric Cancer

Summary: Despite the improvement of surgical resection as primary curative treatment for gastric cancer, more than 70% of patients with stage IIIB and IV disease undergoing radical primary tumor resection relapse and die within 5 years. Therefore, there is an urgent need to further improve the treatment for gastric cancer in this population. Recently reported phase III study comparing capecitabine/cisplatin (XP) versus 5-FU/cisplatin (FP), XP showed better activity and tolerability compared with FP. To improve treatment outcomes of XP chemotherapy, the investigators performed a phase I-II study of docetaxel, capecitabine and cisplatin in advanced gastric cancer (AGC). Phase I-II study of docetaxel, capecitabine and cisplatin as first-line chemotherapy in advanced gastric cancer (Kang et al, Proc Am Soc Clin Oncol 22,328.2003). The docetaxel/capecitabine/cisplatin (DXP) chemotherapy was highly active for the 1st-line chemotherapy of AGC. These findings and experience encourages the investigators to design the adjuvant trial of DXP chemotherapy in patients with resected gastric cancer. The aim of this study is to assess the efficacy and safety of adjuvant DXP in this patient population.

Detailed description: Previous in phase II study of docetaxel, capecitabine and cisplatin,total 40 pts with measurable disease, median 6 cycles of chemotherapy, there were 4 confirmed complete responses (CRs) and 23 confirmed partial responses (PRs), with the overall response rate of 67.5% (95% confidence interval, 52.7 ~ 82.3) in intention-to-treat analysis. Ten patients underwent surgical resection after 4 ~ 9 cycles of chemotherapy. Four pathologic CRs were identified. With a median follow-up of 14 months (range, 1 to 28), median time to progression was 7.7 months, and median overall survival was 16.9 months. The DXP chemotherapy was highly active for the 1st-line chemotherapy of AGC (Kang et al, Proc Am Soc Clin Oncol 22,328.2003).

Eligibility: Inclusion Criteria:
  -  Histologically or cytologically documented gastric adenocarcinoma
  -  Age 18 -70
  -  Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  -  Pathologic stage IIIB or IV
  -  complete resection (R0 resection)
  Exclusion Criteria:
  -  Other tumor type than adenocarcinoma
  -  R1 or R2 resection
  -  Presence of distant metastasis
  -  Gastric outlet obstruction or intestinal obstruction
  -  Evidence of gastrointestinal bleeding
  -  Other serious illness or medical conditions

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

Clinical trial: Study of Ixabepilone in Asian Subjects With Unresectable or Metastatic Gastric Cancer

Summary: The purpose of this study was to determine whether ixabepilone is effective in the treatment of unresectable or metastatic gastric cancer in Asian participants.


Eligibility: Inclusion Criteria:
  -  Histologically confirmed gastric carcinoma originating from the stomach or gastroesophageal junction
  -  Must have unresectable or metastatic disease
  -  Asian ethnicity
  -  Must have failed prior fluoropyrimidine-based chemotherapy
  -  Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
  -  measurable disease by with Response Evaluation Criteria in Solid Tumors (RECIST) guidelines
  Exclusion Criteria:
  -  >1 prior chemotherapy regimen in the metastatic setting or >2 prior chemotherapy if subject also received adjuvant therapy
  -  Receipt of prior ixabepilone
  -  ECOG ≥2
  -  Known brain or meningeal metastasis
  -  Known viral hepatitis
  -  Prior taxane therapy
  -  Uncontrolled non-cancer related medical condition
  -  Second malignancy
  -  Peripheral neuropathy ≥ grade 2
  -  Inadequate hematologic, renal and hepatic function

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

Clinical trial: Confocal Laser Endomicroscopy for the Detection of Gastric Intestinal Metaplasia: a Randomized Controlled Trial

Summary: The purpose of this study is to assess whether confocal laser endomicroscopy can reduce the biopsy number needed per patient for the detection of gastric intestinal metaplasia without the loss of corresponding diagnostic yield.

Detailed description: Gastric intestinal metaplasia is a well-known premalignant lesions for intestinal type gastric cancer. However, present guidelines such as the updated Sydney System require multiple biopsies whereas reveal an unsatisfactory yield considering the detection and surveillance of these lesions. Confocal laser endomicroscopy is a newly developed endoscopic device that enables microscopic view of the digestive tract. Previous study has showed high sensitivity and specificity for in vivo diagnosis of gastric intestinal metaplasia using confocal laser endomicroscopy. This study aims to assess the real number of biopsies that can be reduced for the detection of gastric intestinal metaplasia using confocal laser endomicroscopy.

Eligibility: Inclusion Criteria:
  -  40 years old ≤ age < 80 years old
  -  Patients with dyspeptic symptoms and/or with certain risk factors of gastric intestinal metaplasia
  -  Able to give informed consent.
  Exclusion Criteria:
  -  Esophageal, gastric or duodenal cancer or other malignancy
  -  Known GIM or intraepithelial neoplasia in upper GI tract
  -  Scheduled for endoscopic therapy
  -  History of upper GI tract surgery
  -  Reflux esophagitis or acute gastritis or peptic ulcers
  -  Acute upper gastrointestinal bleeding
  -  Coagulopathy or bleeding disorders
  -  Allergy to fluorescein sodium
  -  Pregnant or breast-feeding (for females)
  -  Impaired renal function

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

Clinical trial: An Observational Study of CPT-11 Plus Platinum Analogues Regimens and UGT1A1 Genotypes in Solid Tumors

Summary: The purpose of this study is to examine the correlation between UGT1A1 genotypes and the safety of CPT-11 plus platinum analogues (cisplatin, carboplatin and nedaplatin) regimens for patients with lung cancer, cervical cancer, ovarian cancer and gastric cancer.


Eligibility: Inclusion Criteria:
  -  Small cell lung cancer, non-small cell lung cancer, cervical cancer, ovarian cancer and gastric cancer
  -  Patients with UGT1A1 genotype *1/*6, *1/*28, *6/*6, *28/*28 and *6/*28
  -  Patients to receiving CPT-11 plus platinum analogues (cisplatin, carboplatin and nedaplatin) regimens (with or without molecular targeted agents)
  Exclusion Criteria:
  -  Contraindication of CPT-11
  -  ECOG PS 3-4

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 Dose Escalation Study of MK1775 in Combination With 5-FU or 5-FU/CDDP in Patients With Advanced Solid Tumor (1775-005)

Summary: The study evaluates safety of MK1775 in monotherapy, and in combination with 5-FU alone or with 5-FU/CDDP in Japanese patients with solid tumor


Eligibility: Inclusion Criteria:
  -  Parts 1 and 2-A: Patient must have a histologically or cytologically confirmed locally advanced or metastatic solid tumor failed to respond to standard therapy, progressed despite standard therapy, or for which standard therapy does not exist
  -  Parts 2-B and 3: Patient must have a histologically or cytologically confirmed locally advanced or metastatic esophageal, head and neck, or gastric cancer, and be a candidate of 5-Fluorouracil and Cisplatin regimen defined in this study
  -  Patient must have performance status of 0 or 1 on the ECOG Performance Scale
  Exclusion Criteria:
  -  Patient who has had chemotherapy, radiotherapy, or biological therapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to the first dose of study drug or who has not recovered from adverse events due to agents administered more than 4 weeks earlier
  -  Patient with a known primary central nervous system tumor
  -  Patient has known hypersensitivity to any of the components of the combination study therapy or its analogs
  -  Patient is receiving "alternative" cancer medications such as plant-derived products and their analogs with anti-tumor activity within 1 week prior to entering the study.
  -  Patient must not have prior radiation therapy to more than 30% of the bone marrow and must have recovered for at least 3 weeks from the hematologic toxicity of prior radiotherapy

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

Clinical trial: RAD001 in Combination With Capecitabine and Oxaliplatin (XELOX) in Patients With Advanced Gastric Cancer

Summary: It is expected that RAD001 works in gastric cancer by inhibiting PI3K/AKT/mTOR pathway and Hif1A (hypoxia inducible factor 1, alpha subunit), a key player in angiogenesis and the growth of tumors like renal cell carcinoma.However, RAD001 alone looks not enough to control gastric cancer. By the mechanisms above, RAD001 can show additive or synergistic effect in combination with conventional chemotherapy. In this study, XELOX was selected as a conventional combination chemotherapy because it was proven very active and safe in gastric cancer. Combination of XELOX and RAD001 has been never tried for the treatment of cancer patients yet. So, the optimal dose will be first determined in this phase I study

Detailed description: For the first cohort of this phase I study, each drug of capecitabine, oxaliplatin, and RAD001 will be started at one or two dose below the ordinary full dose of each drug as a single agent.

Eligibility: Inclusion Criteria:
  -  Histologically or cytologically documented unresectable or metastatic adenocarcinoma of stomach or gastroesophageal junction
  -  No history of chemotherapy or radiation
  -  Age 18 to 70 years old
  -  Estimated life expectancy of at least 3 months
  -  Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  -  Adequate bone marrow function (white blood cell counts >3,000/uL, absolute neutrophil count>1,500/uL, Platelets>100,000/uL, Hgb>8 g/dL)
  -  Adequate kidney function (creatinine<1.5 mg/dL)
  -  Adequate liver function (bilirubin<1.5 mg/dL, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level <3 times the upper normal limit (5 times for patients with liver metastasis))
  -  Signed written informed consent
  Exclusion Criteria:
  -  Past or concurrent history of neoplasm other than gastric adenocarcinoma except for curatively treated basal cell carcinoma of skin 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
  -  Bowel obstruction
  -  Evidence of serious gastrointestinal bleeding
  -  Peripheral neuropathy (NCI CTC AE 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
  -  Patients with known history of ischemic heart disease and/or with myocardial infarction
  -  Known allergy to study drugs
  -  Administration of drugs showing interaction with RAD001

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 Study of Olaparib With Paclitaxel Versus Paclitaxel in Gastric Cancer Patients

Summary: To assess the efficacy of olaparib when given in combination with paclitaxel compared with paclitaxel alone as defined by progression-free survival (PFS), in all patients with recurrent and metastatic gastric cancer who progress following first-line therapy


Eligibility: Inclusion Criteria:
  -  Recurrent or metastatic gastric cancer that has progressed following first line-therapy
  -  Confirmed ATM protein status by IHC archival tumour sample
  -  At least one lesion (measurable and/or non-measurable) that can be accurately assessed by imaging (CT/MRI) at baseline and follow up visits
  Exclusion Criteria:
  -  More than one prior chemotherapy regimen for the treatment of gastric cancer in the metastatic or recurrent setting
  -  Any previous treatment with a PARP inhibitor, including olaparib
  -  Patients with second primary cancer, except; adequately treated non melanoma skin cancer, curatively treated in situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for >5 years

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 Trial of Reconstruction After Distal Gastrectomy for Gastric Cancer

Summary: The purpose of this study is to evaluate the quality of life (QOL) after Billroth-I reconstruction (B-I) following distal gastrectomy, compared with Roux-en Y reconstruction (R-Y) in patients with gastric cancer.

Detailed description: The purpose of this study is to evaluate the quality of life (QOL) after Billroth-I reconstruction (B-I) following distal gastrectomy, compared with Roux-en Y reconstruction (R-Y) in patients with gastric cancer. There is no prospective randomized study of the two operative procedures focusing on postoperative QOL. The investigators conducted a prospective randomized trial on 120 patients who underwent distal gastrectomy comparing Billroth-I reconstruction and Roux-en Y reconstruction.
  The primary endpoint was the postoperative QOL. The secondary endpoints were the incidence of postoperative complications, nutritional status, and the incidence of the remnant gastritis and the reflux esophagitis. Patients were recruited into this study before surgery, on the basis of whether distal gastrectomy was anticipated at Wakayama Medical University Hospital(WMUH) for gastric cancer, and appropriate informed consent was obtained. Exclusion criteria was 1) patients with severe complications which were possible to prolong hospital stay, 2) patients with history of other organ malignancies, 3) patients who were diagnosed inadequacy for this study by a physician, and 4) patients without an informed consent.

Eligibility: Inclusion Criteria:
  -  Histologically confirmed adenocarcinoma of stomach
  -  Performance status: Eastern Cooperative Oncology Group (ECOG) 0-1
  -  Tumor located in the antrum or the angle or the lower body of stomach
  -  Appropriate informed consent was obtained.
  Exclusion Criteria:
  -  Patients with severe complications which were possible to prolong hospital stay
  -  Patients with history of other organ malignancies
  -  Patients who were diagnosed inadequacy for this study by a physician
  -  Patients without an informed consent

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

Clinical trial: Gastric Decompression After Sub-total Gastrectomy

Summary: The purpose of this study is to test the utility of the nasogastric tube, which is used to decompress and as "guardian" of gastro-jejunal anastomosis, in patients undergoing distal subtotal gastrectomy for gastric cancer with reconstruction according to Billroth II or according Roux.

Detailed description: A silastic naso-gastric tube (Rusch® distributed by Teleflex Medical Srl) is used in the naso-gastric/jejunal tube group

Eligibility: Inclusion Criteria:
  -  All people subjected to subtotal gastrectomy for distal gastric adenocarcinoma.
  Exclusion Criteria:
  -  People undergoing enteral nutrition through naso-jejunal tube

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

Clinical trial: Phase II Trial of AUY922 vs. Comparators in Advanced Gastric Cancer

Summary: A clinical trial to determine the effectiveness and safety of AUY922 compared to other drugs known to be effective against gastric cancer in second line therapy for patients who have failed one line of chemotherapy.


Eligibility: Inclusion Criteria:
  -  Radiologically confirmed advanced gastric cancer
  -  One previous line of chemotherapy
  -  Progressive disease
  -  One measurable lesion
  -  Blood tests within protocol ranges
  -  (WHO) Performance Status ≤ 1
  -  Able to sign informed consent
  Exclusion Criteria:
  -  No symptomatic brain metastases
  -  No coumarin type anticoagulants
  -  No liver or kidney disease
  -  No impaired heart function
  -  No pregnant or lactating women
  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: A Trial of RAD001/Capecitabine in Refractory Gastric Cancer

Summary: Capecitabine is an oral fluoropyrimidine that has been shown to be effective in the treatment of metastatic gastric and colorectal cancer patients. On the basis of capecitabine-based chemotherapy which is accepted as a standard regimen in gastric cancer, we will perform the phase I/II study with all-oral regimen of RAD001 with capecitabine for these refractory gastric cancer patients.


Eligibility: Inclusion Criteria:
  1. Histologically or cytologically proven gastric cancer patients
  2. Adequate organ function as defined by the following criteria:
  A. Serum aspartate transaminase (AST; serum glutamic oxaloacetic transaminase (SGOT)) and serum alanine transaminase (ALT; serum glutamic pyruvic transaminase (SGPT)) ≤ 2.5 x local laboratory upper limit of normal (ULN), or AST and ALT less than or equal to 5 x ULN if liver function abnormalities are due to underlying malignancy B. Total serum bilirubin ≤ 3.0 mg/dL C. Absolute neutrophil count (ANC) ≥1500/µL D. Platelets ≥100,000/µL E. Hemoglobin ≥9.0 g/dL (may be transfused or erythropoietin treated) F. Serum calcium ≤12.0 mg/dL G. Serum creatinine ≤1.5 x ULN
  3. Patients with CNS metastasis must have stable neurologic function without evidence of CNS progression within 8 weeks
  4. Patients who have failed to at least two previous cytotoxic chemotherapy for advanced gastric cancer (adjuvant treatment will be counted as one regimen if received < 12 months from the start of experimental treatment)
  5. At least one measurable lesion by RECIST criteria
  6. ECOG PS 0-2
  7. Patients with informed consent
  Exclusion Criteria:
  1. Major surgery or radiation therapy within 4 weeks of starting the study treatment.
  2. History of or known carcinomatous meningitis, or evidence of symptomatic leptomeningeal disease on screening CT or MRI scan.
  3. Ongoing cardiac dysrhythmias of NCI CTCAE grade ≥ 2.
  4. Pregnancy or breastfeeding.
  5. Prior exposure to the study drug.
  6. Patients unable to swallow oral medications.

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

Clinical trial: Expression of S100A2 and Trefoil Factor Family Members in Epstein-Barr Virus Related Gastric Cancer

Summary: The investigators hypothesize that aberrant hypermethylation of tumour suppressor genes is an important mechanism for Epstein-Barr Virus (EBV) - related gastric carcinogenesis, the promoter hypermethylation status and the expression of S100A2 and TFF1 might be different between EBV-associated gastric cancer (GC) and non EBV-associated GC.


Eligibility: Inclusion Criteria:
  Exclusion Criteria:

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

Clinical trial: Neoadjuvant Treatment of Colon Cancer

Summary: This study will investigate
  -  the effect of preoperative combination chemotherapy in patients with locally advanced colon cancer with mutation in the KRAS, BRAF or PIK3CA gene
  -  the effect of preoperative combination chemotherapy in combination with biological treatment in patients without mutation in the KRAS, BRAF or PIK3CA gene.


Eligibility: Inclusion Criteria:
  -  Histologically verified locally advanced T3 or T4 colon cancer assessed by CT scan
  -  Analysis of KRAS, BRAF, PIK3CA
  -  Age ≥18 år
  -  Performance status ≤ 2
  -  Hematology
  -  ANC ≥ 1.5x10^9/l. Thrombocytes ≥ 100x10^9/l.
  -  Biochemistry
  -  Bilirubinaemia ≤ 3 x UNL. ALAT ≤ 5 x UNL
  -  Consent to translational research
  -  Fertile women must present a negative pregnancy test and use secure birth control during and 3 months after treatment.
  -  Written and orally informed consent.
  Exclusion Criteria:
  -  Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ≤ 1 year before enrollment, active severe infections or other concurrent disease.
  -  Peripheral neuropathy NCI grade >1
  -  Other malignant disease within 5 years prior to enrollment, except basal cell squamous carcinoma of the skin and cervical carcinoma-in-situ
  -  Other investigational treatment within 30 days prior to treatment start
  -  History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan.
  -  Bleeding tumors
  -  Hypersensitivity to one or more of the substances

Relevance to patient case: not relevant