araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 61-year-old male with Ampullary carcinoma. Genetic variant: KRAS. Other conditions: None.

Clinical trial: Phase 2 Study on Use of a Combination of Pemetrexed in Patients With Advanced Gastric Carcinoma

Summary: Pemetrexed has shown an anti-tumor activity in advanced gastric cancer patients in a previous study, while cisplatin is widely used in the combination chemotherapy of gastric cancer. Pemetrexed has shown synergy with cisplatin in preclinical models and in various human cancers. The introduction of vitamin supplementation has made treatment with pemetrexed plus cisplatin safe and well tolerated. The present phase 2 study is an effort to determine the efficacy and safety of the combination of pemetrexed and cisplatin in Korean patients with gastric carcinoma who had no prior palliative chemotherapy for advanced disease. The patients, who will give their consent for participating in this study, will be screened for their eligibility and on meeting pre-defined study eligibility criteria, they will receive an intravenous therapy of the combination of pemetrexed and cisplatin for number of times that in the opinion of their treating physician is appropriate for them. A response rate of 30% is considered as the minimum activity level of interest for this patient population.


Eligibility: Inclusion Criteria:
  -  diagnosis of adenocarcinoma of the stomach
  -  Stage IV disease not amenable to curative surgery.
  -  Disease status must be that of measurable disease as defined by RECIST criteria
  -  Performance Status of 0 or 1 on the ECOG Scale and adequate organ function.
  -  Signed informed consent from patient
  Exclusion Criteria:
  -  Prior palliative chemotherapy for advanced disease.
  -  Known or suspected brain metastasis or Second primary malignancy that is clinically detectable at the time of consideration for study enrollment.
  -  Concurrent administration of any other tumor therapy
  -  Inability to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs) 2 days before, the day of, and 2 days after the dose of ALIMTA plus cisplatin.
  -  Inability or unwillingness to take folic acid, vitamin B12 supplementation, or dexamethasone.

Relevance to patient case: not relevant
Patient case: 61-year-old male with Ampullary carcinoma. Genetic variant: KRAS. Other conditions: None.

Clinical trial: Docetaxel and Radiation Therapy in Treating Patients With Stage II or Stage III Cancer of the Larynx or Hypopharynx

Summary: RATIONALE: Drugs used in chemotherapy, such as docetaxel work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving docetaxel together with radiation therapy may kill more tumor cells.
  PURPOSE: This phase II trial is studying how well giving docetaxel together with radiation therapy works in treating patients with stage II or stage III cancer of the larynx or hypopharynx.

Detailed description: OBJECTIVES:
  Primary
  -  Determine the objective response of the primary tumor in patients with stage II or III squamous cell carcinoma of the larynx or hypopharynx treated with docetaxel and radiotherapy.
  Secondary
  -  Determine the local relapse-free survival of patients treated with this regimen.
  -  Determine the larynx-preservation survival of patients treated with this regimen.
  -  Determine the overall survival of patients treated with this regimen.
  -  Determine the protocol completion rate in patients treated with this regimen.
  -  Determine the adverse effects of this regimen in these patients.
  OUTLINE: This is a multicenter study.
  Patients receive docetaxel IV over 1 hour on days 1, 8, 15, 22, and 29 and undergo radiotherapy on days 1-5, 8-12, 15-19, 22-26, and 29-33.
  PROJECTED ACCRUAL: A total of 25-50 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically confirmed squamous cell carcinoma of the larynx or hypopharynx
  -  Stage II or III disease
  -  Solitary lymph node metastasis located in level II-III allowed
  -  Age 70 and over OR meets 1 of the following criteria:
  -  Creatinine clearance 30-60 mL/min
  -  History of platinum allergy
  -  Diagnosis of unstable angina
  -  Ineligible for systemic chemotherapy, including high-dose platinum-containing regimens
  PATIENT CHARACTERISTICS:
  Age
  -  See Disease Characteristics
  Performance status
  -  ECOG 0-2
  Life expectancy
  -  Not specified
  Hematopoietic
  -  WBC > 3,000/mm^3
  -  Neutrophil count > 1,500/mm^3
  -  Hemoglobin > 10 g/dL
  -  Platelet count > 100,000/mm^3
  Hepatic
  -  AST and ALT ≤ 2.0 times upper limit of normal
  -  Bilirubin < 2.0 mg/dL
  -  No severe liver disease
  Renal
  -  See Disease Characteristics
  -  Creatinine clearance ≥ 30 mL/min
  -  No severe renal disease
  Pulmonary
  -  No severe pulmonary disease
  Other
  -  No severe neurologic disease
  PRIOR CONCURRENT THERAPY:
  Biologic therapy
  -  Not specified
  Chemotherapy
  -  No prior systemic chemotherapy
  Endocrine therapy
  -  Not specified
  Radiotherapy
  -  No prior radiotherapy
  Surgery
  -  No prior surgery

Relevance to patient case: not relevant
Patient case: 61-year-old male with Ampullary carcinoma. Genetic variant: KRAS. Other conditions: None.

Clinical trial: Gemcitabine and Oxaliplatin in Treating Patients With Metastatic Pancreatic Cancer

Summary: RATIONALE: Drugs used in chemotherapy, such as gemcitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known whether giving both of these drugs on the same day is more effective than giving them on different days.
  PURPOSE: This randomized phase III trial is studying two different schedules of gemcitabine and oxaliplatin to compare how well they work in treating patients with metastatic pancreatic cancer.

Detailed description: OBJECTIVES:
  Primary
  -  Compare the objective response rate in patients with metastatic adenocarcinoma of the pancreas treated with two different schedules of gemcitabine hydrochloride and oxaliplatin.
  Secondary
  -  Compare the clinical benefits and tolerability of these regimens in these patients.
  -  Compare the progression-free and overall survival of patients treated with these regimens.
  OUTLINE: This is a randomized, multicenter study. Patients are stratified according to the participating center and ECOG performance status (0 or 1 vs 2). Patients are randomized to 1 of 2 treatment arms.
  -  Arm I: Patients receive gemcitabine hydrochloride IV over 100 minutes on day 1 and oxaliplatin IV over 2 hours on day 2.
  -  Arm II: Patients receive gemcitabine hydrochloride IV over 100 minutes followed by oxaliplatin IV over 2 hours on day 1.
  In both arms, treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
  After completion of study treatment, patients are followed periodically.
  PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically confirmed adenocarcinoma of the pancreas
  -  Metastatic disease
  -  Measurable disease (primary tumor or metastasis)
  -  At least 1 cm in diameter by spiral CT scan
  -  No ampulla of Vater carcinoma or biliary adenocarcinoma
  -  No known brain metastases
  PATIENT CHARACTERISTICS:
  -  ECOG performance status (PS) 0-2 or Karnofsky PS 60-100%
  -  Life expectancy more than 12 weeks
  -  Absolute neutrophil count > 1,500/mm^3
  -  Platelet count > 100,000/mm^3
  -  Alkaline phosphatase < 5 times normal
  -  Bilirubin < 1.5 times normal
  -  Creatinine < 1.5 times normal
  -  No pre-existing neuropathy
  -  No unstable or uncontrolled pain
  -  Not pregnant or nursing
  -  Fertile patients must use effective contraception
  -  No serious cardiovascular disease
  -  No serious respiratory disease
  -  No uncontrolled or persistent hypercalcemia
  -  No psychological, familial, social, or geographical condition that would preclude study treatment
  -  No other active malignancy
  PRIOR CONCURRENT THERAPY:
  -  No prior chemotherapy or radiotherapy
  -  No concurrent corticosteroids

Relevance to patient case: not relevant
Patient case: 61-year-old male with Ampullary carcinoma. Genetic variant: KRAS. Other conditions: None.

Clinical trial: Determinants of Vitamin K Metabolism

Summary: The purpose of this study is to learn how the body responds to different amounts of vitamin K in the diet in order to understand the roles that vitamin K may have in the body. We also need to determine if older adults need more or less vitamin K in their diet compared to younger adults in order to maintain normal body stores of vitamin K.

Detailed description: Vitamin K has a role in bone health, but little is known about vitamin K metabolism in aging and in maintenance of bone mass. The limited understanding of vitamin K metabolism impedes the establishment of dietary recommendations for vitamin K, and the interpretation of results from clinical trials on vitamin K supplementation and bone health of women in a narrow age group. This study is the first to assess the role of dietary and other factors that influence the response to vitamin K status and bone turnover to vitamin K depletion and repletion in adults. This study also compares the absorption efficiency and body retention of vitamin K relative to current vitamin K status. Men and women [21 younger (18-40y) and 21 older (55+y)] will participate in a 62-d metabolic study, with a 5d run-in period, followed by a 28d dietary vitamin K restriction period (10 ug/d), and ending with a 28d dietary vitamin K supplementation period (500 ug/d). Coagulation times will be monitored during the dietary restriction period. Serial measurements of vitamin K status markers and of bone turnover markers will show the response of vitamin K to dietary manipulation for both age groups under identically controlled dietary conditions. Deuterium-labeled vitamin K in collards will be used to compare the absorption of vitamin K during a vitamin K-deplete state to that of a vitamin K-replete state. Vitamin K is transported in triglyceride-rich lipoproteins, which may vary among individuals due to differences in adiposity and lipid homeostasis. Therefore, measurement of body composition by Dual Energy X-Ray Absorptiometry (DXA) and plasma lipids will provide insight into the role of lipids in absorption and transport of vitamin K. The findings of this study are critical for the interpretation of the epidemiologic and clinical data used to determine the protective role vitamin K may have in chronic disease prevention.

Eligibility: Inclusion Criteria:
  Exclusion Criteria:
  -  kidney, GI, or liver disease requiring treatment
  -  prescribed osteoporosis medications in the previous 3 months
  -  use of acid reducers more than twice per week
  -  blood clotting disorder and/or abnormal clotting time
  -  warfarin or anticoagulant use in the previous 12 months
  -  diabetes
  -  smoking
  -  hormone therapy in the previous 3 months
  -  oral contraceptive use in the previous 3 months; pregnancy
  -  strict vegetarian diet

Relevance to patient case: not relevant
Patient case: 61-year-old male with Ampullary carcinoma. Genetic variant: KRAS. Other conditions: None.

Clinical trial: Effects of Topical Vitamin K, Vitamin K and Retinol, and Arnica on Post-Laser Bruising

Summary: The objective of this study is to assess the comparative utility of topical formulations in hastening the resolution of skin bruising. For each subject, four standard bruises of 7 mm diameter each were created on the bilateral upper inner arms, 5 cm apart, two per arm, using a 595-nm pulsed-dye laser. Randomization was used to assign one topical agent (5% vitamin K, 1% vitamin K and 0.3% retinol, 20% arnica or white petrolatum) to exactly one bruise per subject, which was then treated under occlusion twice a day for 2 weeks. A dermatologist rated bruises in standardized photographs immediately after bruise creation and at week 2.


Eligibility: Inclusion Criteria:
  -  Age 20-60
  -  Subjects are in good health.
  -  Subjects have willingness and the ability to understand and provide informed consent for participation in the study.
  Exclusion Criteria:
  -  Subjects who are currently using any anticoagulation therapy (Warfarin, Heparin, Aspirin)
  -  Subjects who have a history of bleeding disorders.
  -  Subjects who are unable to understand the protocol or to give informed consent
  -  Subjects with mental illness
  -  Subjects who are pregnant or nursing.
  -  Subjects who have active systemic or local infection
  -  Subjects with systemic or local skin disease.
  -  Subjects with systemic illness.

Relevance to patient case: not relevant
Patient case: 61-year-old male with Ampullary carcinoma. Genetic variant: KRAS. Other conditions: None.

Clinical trial: PRIME: Panitumumab Randomized Trial In Combination With Chemotherapy for Metastatic Colorectal Cancer to Determine Efficacy

Summary: The purpose of this study is to determine the treatment effect of panitumumab in combination with FOLFOX compared to FOLFOX alone as first line therapy for metastatic colorectal cancer


Eligibility: Inclusion Criteria:
  -  Man or woman at least 18 years old
  -  Diagnosis of metastatic colorectal cancer
  -  At least 1 uni-dimensionally measurable lesion of at least 20 mm per modified RECIST
  -  Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
  -  Paraffin-embedded tumor tissue from the primary tumor or metastasis available for central analyse 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 ≥ 5 years before randomization
  -  Prior chemotherapy or systemic therapy for the treatment of metastatic colorectal carcinoma except: adjuvant fluoropyrimidine-based chemotherapy or prior fluoropyrimidine therapy administered solely for the purpose of radiosensitization
  -  Prior oxaliplatin therapy
  -  Prior anti-epidermal growth factor receptor (EGFr) antibody therapy (eg, cetuximab) or treatment with small molecule EGFr inhibitors (eg, erlotinib)
  -  Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) 1 year prior to randomization History of interstitial lung disease (eg, pneumonitis or pulmonary fibrosis) or evidence of interstitial lung disease on baseline chest computed tomography (CT) scan
  -  Active inflammatory bowel disease or other bowel disease causing chronic diarrhea (defined as > Common terminology criteria (CTC) grade 2 [CTCAE version 3.0])
  -  Peripheral sensory neuropathy with functional impairment

Relevance to patient case: not relevant
Patient case: 61-year-old male with Ampullary carcinoma. Genetic variant: KRAS. Other conditions: None.

Clinical trial: SUTENT® In The First Line Treatment Of Renal Cell Carcinoma

Summary: This non-interventional study includes patients with advanced and/or metastatic renal cell carcinoma who are treated with SUTENT and who did not receive any other systemic therapy before. The aim of the trial is to increase knowledge about quality of life, safety, efficacy and tolerability under conditions of routine use of Sutent. The individual observation period of each patient will be
  1 year.

Detailed description: The Statistical Analysis Plan provides detailed specification of the analysis

Eligibility: Inclusion Criteria:
  -  First-line treatment in patients with metastatic renal cell carcinoma
  Exclusion Criteria:
  -  Any previous systemic therapy of renal cell carcinoma except for adjuvant treatment

Relevance to patient case: not relevant
Patient case: 61-year-old male with Ampullary carcinoma. Genetic variant: KRAS. Other conditions: None.

Clinical trial: Fulvestrant in Hormone Refractory Prostate Cancer

Summary: The purpose of this study is to determine if treatment with fulvestrant leads to a slowing of tumor progression in patients who have developed androgen-independent (AIPC) or hormone-refractory prostate cancer (HRPC) and who have a rising serum prostate specific antigen (PSA).

Detailed description: The purpose of this study is to determine if treatment with fulvestrant leads to a slowing of tumor progression in patients who have developed androgen-independent (AIPC) or hormone-refractory prostate cancer (HRPC) and who have a rising serum prostate specific antigen (PSA). In vitro studies have shown that fulvestrant downregulates androgen receptor (AR) in LNCaP cancer cell lines to a significant extent, thereby inhibiting growth of tumor cells. In addition, it is important to emphasize that fulvestrant has also been found to decrease growth of AR-negative prostate cancer cells. These observations provide the rational for using fulvestrant for the treatment of AIPC and HRPC.

Eligibility: Inclusion Criteria:
  -  Must give signed written informed consent
  -  Must be of age 18 years or older
  -  Histologically confirmed adenocarcinoma of the prostate
  -  Must be currently receiving LHRH agonists and have castrate levels of testosterone or have had an orchiectomy
  -  Must have had rise in PSA despite anti-androgen withdrawal
  -  Must exhibit two consecutive rises in PSA after the last hormonal manipulation
  -  Minimum PSA > 5mg/dL
  -  KPS > 80%
  -  Up to one prior chemotherapy treatments allowed
  -  Life expectancy of greater than 6 months
  Exclusion Criteria:
  -  Concomitant hormonal therapy other than an LHRH
  -  Noncompliance
  -  Platelets less than 100 x 10e9 /L
  -  International normalization ratio (INR) greater than 1.6
  -  Total bilirubin greater than 1.5 x ULRR
  -  ALT or AST greater than 2.5 x ULRR if no demonstrable liver metastases or greater than 5.0 x ULRR in presence of liver metastases
  -  History of bleeding diathesis (ie, disseminated intravascular coagulation [DIC], clotting factor deficiency)
  -  History of long-term anticoagulant therapy (other than antiplatelet therapy)
  -  History of hypersensitivity to active or inactive excipients of fulvestrant (ie, castor oil or Mannitol)

Relevance to patient case: not relevant
Patient case: 61-year-old male with Ampullary carcinoma. Genetic variant: KRAS. Other conditions: None.

Clinical trial: Comparing Endoscopic Based Stent Strategy Versus Bypass Surgery in Non-resectable Periampullary Cancer

Summary: Randomized study comparing endoscopic stent insertion strategy versus double-bypass surgery in non-resectable periampullary cancer

Detailed description: Experience shows that patients with advanced periampullary cancer suffer not only from jaundice but in 25 -30% of cases also duodenal stricture with nausea, vomiting and nutritional difficulties. Ten years ago, the only palliative treatment for these patients was a bypass operation for bile flow and intestinal passage. This operation was often associated with a high morbidity. Developments in endoscopic treatments allow palliation with lower morbidity. However, stent treatment is not free of problems like stent dysfunction. During the last ten years, anesthesia and surgical techniques have developed which allow lower postoperative morbidity compared to earlier treatments. A total of 70 patients were randomized to surgery with hepaticojejunostomy on Roux loop and gastrojejunostomy or endoscopic treatment with self-expanding metallic stent in the bile duct and so-called duodenal stent. Based on the inclusion of 70 patients, we expected a 20% difference in some of the primary variables with a power of 80%.

Eligibility: Inclusion Criteria:
  -  Patients with a locally advanced periampullary neoplastic process with extrahepatic bile duct obstruction.
  -  The patient tumor burden and general condition should be such that treatment related morbidity and mortality is calculated as "reasonable" and both treatment strategies are considered "applicable".
  Exclusion Criteria:
  -  Non consent.
  -  The patients' general condition will not tolerate either treatment (strategy).
  -  Previous laparotomy or laparoscopy.
  -  Life expectancy < 3 months.
  -  Inability to participate (language, social, etc.)

Relevance to patient case: not relevant
Patient case: 61-year-old male with Ampullary carcinoma. Genetic variant: KRAS. Other conditions: None.

Clinical trial: Panitumumab Plus FOLFIRI in First-line Treatment of Metastatic Colorectal Cancer

Summary: To estimate the effect of KRAS mutation status (Wild-type versus Mutant) on objective response rate and other measures of efficacy for patients treated with panitumumab in combination with a chemotherapy regimen of irinotecan, 5-fluorouracil, and leucovorin (FOLFIRI) as first-line therapy for metastatic colorectal cancer (mCRC).


Eligibility: Inclusion Criteria:
  -  Diagnosed with histologically- or cytologically-confirmed metastatic adenocarcinoma of the colon and/or rectum.
  -  Measurable disease according to modified RECIST guidelines.
  -  Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
  -  Paraffin-embedded tissue or unstained tumour slides from primary or metastatic tumour available for central lab analysis.
  -  Adequate haematologic, renal, hepatic and metabolic function.
  Exclusion Criteria:
  -  Central nervous system metastases.
  -  Prior systemic therapy for the treatment of metastatic colorectal carcinoma with the exception of adjuvant fluoropyrimidine-based chemotherapy given at least six months prior to initiating study treatment.
  -  Prior anti-epidermal growth factor receptor (EGFr) antibody therapy (e.g. cetuximab) or treatment with small molecule EGFr tyrosine kinase inhibitors (e.g. erlotinib).
  -  Prior radiotherapy within 14 days prior to screening, and for which all signs of early radiological toxicity have not abated.
  -  Significant cardiovascular disease including unstable angina or myocardial infarction within six months before initiating study treatment or a history of ventricular arrhythmia.
  -  History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis on baseline chest computed tomography (CT scan.
  -  Active inflammatory bowel disease or other bowel disease causing chronic diarrhoea (defined as > 4 loose stools per day).
  -  History of Gilbert's syndrome or dihydropyrimidine deficiency.
  -  Known positive test for human immunodeficiency virus infection, hepatitis C virus, chronic active hepatitis B infection.
  -  Any investigational agent within 30 days before initiation of study treatment.
  -  Must not have had a major surgical procedure within 28 days prior to initiation of study treatment.
  -  Subject who is pregnant or breast-feeding.
  -  Woman or man of childbearing potential not consenting to use adequate contraceptive precautions during the course of the study and for six months after the last study drug administration for women, and one month for men.
  -  Other protocol specified criteria and specific details may apply.

Relevance to patient case: not relevant