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

Clinical trial: A Study of BIBW 2992 (Afatinib) in Patients With Metastatic Colorectal Cancer

Summary: This Phase II study is open to patients with metastatic colorectal cancer who have tried but failed chemotherapy regimens containing oxaliplatin and irinotecan. Patients must not have received anti-EGFR (Epidermal Growth Factor Receptor) treatment (for example, cetuximab, panitumumab) in the past. Patients with wild-type KRAS (v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog) colorectal cancer will be randomised to receive either BIBW 2992 or cetuximab. Patients with KRAS mutated colorectal cancer will not be randomised, but will all receive BIBW 2992. The main objectives of the study are: to compare the effectiveness of BIBW 2992 with that of cetuximab in patients with KRAS wild type cancer, and to assess the effectiveness of BIBW 2992 in patients with KRAS mutated cancer.


Eligibility: Inclusion criteria:
  1. Patients with metastatic colorectal cancer who have failed both oxaliplatin- and irinotecan-based regimens
  2. Tumour sample available for KRAS (v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog) mutation testing and other biomarker analyses.
  Exclusion criteria:
  1. Prior treatment with Epidermal Growth Factor Receptor (EGFR) targeting small molecules or antibodies.
  2. Biological treatment (including Bevacizumab or any other antiangiogenic agents) during the trial is not allowed.
  3. Known pre-existing interstitial lung disease.
  4. Planned major surgical procedures during the trial period.

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

Clinical trial: Trial Evaluating Combined Chemotherapy in Patients With Metastatic Pancreatic Adenocarcinoma

Summary: GATE 1 is an open-label, non-comparative, multicentric study evaluating the efficacy and tolerance of the combined use of Gemcitabine, Trastuzumab and Erlotinib as a first-line chemotherapy in metastatic pancreatic cancer patients.
  The patients will be treated intravenously with Gemcitabine at a dose of 1000 mg/m2 for 30 min. For the first eight weeks, Gemcitabine will be administered once weekly for 7 weeks followed by one week of rest. Subsequently, Gemcitabine will be administered once weekly for three weeks followed by one week of rest.
  Trastuzumab will be administered once a week at a dose of 4 mg/kg over 90 min. at D1 and then at 2 mg/kg over 30 min. for the subsequent infusions.
  Erlotinib will be administered orally at a dose of 100 mg/day from C1D1.
  The patients will be subjected to research for the EGFR, HER2 and KRAS status.


Eligibility: Inclusion Criteria:
  -  Metastatic pancreatic adenocarcinoma confirmed by histology
  -  Tumor sample available
  -  Measurable lesion according to RECIST criteria
  -  Performance status ≥ 1
  -  Life expectancy > 3 months
  -  Hematology: Hb ≥ 9g/dL, neutrophils ≥ 1,500/mm3, platelets ≥ 100,000/mm3
  -  Renal function: creatinine ≤ 1.5 x ULN
  -  Hepatic function: total bilirubin ≤ 2.5 x ULN, transaminases ≤ 5 x ULN
  -  Left ventricular ejection fraction (LVEF) ≥ 50%
  -  At least a 6-month delay between the end of any previous gemcitabine-based chemotherapy and diagnosis of metastases
  -  Social security
  -  Informed consent obtained prior to inclusion.
  Exclusion Criteria:
  -  Non metastatic advanced local disease
  -  Presence of cerebral metastases or symptomatic leptomeningeal carcinomatosis
  -  Others cancers except BBC and cervical cancer receiving curative treatment
  -  No previous treatment by Erlotinib or Trastuzumab
  -  Known severe hypersensitivity to Erlotinib, Trastuzumab, murine proteins or Gemcitabine
  -  Presence of significant co-morbidities
  -  Concomitant treatment with other experimental products or other anticancer therapies
  -  Breastfeeding or pregnant female, or patient of reproductive age not using adequate contraception
  -  Legal incapacity or limited legal incapacity

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

Clinical trial: MRI of the Liver With Eovist

Summary: The purpose of this study is to determine if a new magnetic resonance (MR) protocol is better at diagnosing liver lesions.

Detailed description: Hepatocellular carcinoma (HCC), a form of liver cancer, is the seventh most common cause of cancer mortality in the US. The incidence rate of HCC is increasing along with the incidence of Hepatitis B and C which are known to promote HCC. Patients have a better prognosis (survival outlook) if HCC is found and treated at an early stage. MRI is the best imaging modality for diagnosing HCC.
  This study will compare standard MRIs and MRIs performed with a newly developed MR protocol to determine if it is possible to more confidently diagnose HCC.

Eligibility: Inclusion Criteria:
  -  known hepatocellular carcinoma
  -  undergoing MRI of the liver
  Exclusion Criteria:
  -  Contraindication to MRI with IV contrast

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

Clinical trial: Avastin and Chemotherapy Followed by a KRAS Stratified Randomization to Maintenance Treatment for First Line Treatment of Metastatic Colorectal Cancer.

Summary: Patients with metastatic colorectal cancer will be treated with chemotherapy according to investigators choice. In addition to chemotherapy treatment, treatment with bevacizumab will be given concomitantly. This treatment will continue during 18 weeks. Meanwhile, the patients KRAS status will be tested. After having fulfilled these 18 weeks of induction treatment, patients who has responded (complete response/partial response versus stable disease) will be randomized to maintenance treatment. Patients with KRAS WT will be randomized to either bevacizumab alone, or to bevacizumab and erlotinib. Patient with KRAS mutation will be randomized to either bevacizumab, or metronomic capecitabine. Translational research is performed, with purpose to find predictive factors in blood and tumor tissue.


Eligibility: Inclusion Criteria:
  -  Untreated metastatic colorectal carcinoma
  -  Age 18 yrs or over
  -  Measurable disease according to Response Evaluation Criteria in solid Tumors (RECIST criteria)
  -  ECOG performance status 0 or 1
  -  Life expectancy more than 3 months
  -  Adequate haematological, renal and liver function
  -  Tumor tissue available for determination of KRAS mutational status
  -  Blood sample and paraffin embedded tumor tissue for translational research
  Exclusion Criteria:
  -  Adjuvant therapy within 6 months
  -  CNS metastases
  -  Clinically significant atherosclerotic vascular disease

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

Clinical trial: Covered or Uncovered Bile Duct Stents

Summary: The study is investigator initiated. Tumors that gives the narrowing of the bile ducts prevents bile from flowing from the liver to the intestine resulting in jaundice and the risk of bacterial growth in bile with severe infections as a result. Unresectable bile duct strictures have routinely been treated them with plastic stents. The plastic stents have been replaced by self expandable metallic stents.
  These stents remain open longer for reasons that they have a larger diameter so that the bile flows through more easily. One problem with these stents, however, is that the tumor growing through the wire mesh which forms the wall of the stent. This has led to the development of so-called covered stents. Whether covered stents have longer patency is unclear as well as whether they are as safe. There is reason to believe that covered stents remain open longer, but there may be an increased risk of migration and other complications.
  The purpose is to prospectively and randomized compare the two stent types. The study endpoint is the clogging of the stent or the patient's death. We also monitor complications, regress time of the jaundice and success rate of stent placement

Detailed description: 0

Eligibility: Inclusion Criteria:
  -  Patients with unresectable, distal bile duct stricture needing relieved endoscopically
  -  Expected survival greater than 3 months
  -  The patient must give written consent to participate in the study
  Exclusion Criteria:
  -  Stricture close to hilus
  -  Need for interpreter

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

Clinical trial: Nimotuzumab in Combination With Chemoradiation for Local Advanced Esophageal Squamous Cell Carcinoma

Summary: Nimotuzumab is a humanized monoclonal antibody against epidermal growth factor receptor (EGFR). Clinical trials are ongoing globally to evaluate Nimotuzumab in different indications. Nimotuzumab has been approved to treat squamous cell carcinoma of head and neck (SCCHN), glioma and nasopharyngeal carcinoma in different countries. The clinical phase I study of the combination of Nimotuzumab administered concurrently with chemo-irradiation in patients with local advanced esophageal squamous cell carcinoma (LAFSCC) has shown the safety and the potential efficacy of Nimotuzumab. The concurrent trial is a clinical phase II trial designed to assess the efficacy of the combination of Nimotuzumab administered concurrently with chemo-radiotherapy in patients with LAFSCC, and to further investigate its side-effect and toxicity.

Detailed description: The concurrent trial is a clinical phase II trial designed to assess the efficacy of the combination of Nimotuzumab administered concurrently with chemo-radiotherapy in patients with LAFSCC, and to further investigate its side-effect and toxicity.

Eligibility: Inclusion Criteria:
  -  Joined the study voluntarily and signed informed consent form;
  -  Age 18-75
  -  Both genders
  -  Esophageal squamous cell carcinoma confirmed by pathology
  -  Local advanced esophageal squamous cell carcinoma (T2N0M0-TxNxM1a, AJCC 2002)
  -  No radiotherapy, chemotherapy or other treatments prior to enrollment
  -  PS ECOG 0-2
  -  Life expectancy of more than 3 months
  -  Target lesions measurable
  -  Hemoglobin（Hb）≥9 g/dL
  -  WBC≥3x109/L, Neutrophils (ANC )≥1.5x109/L
  -  platelet count (Pt) ≥100x 109/L
  -  Hepatic function: ALAT and ASAT < 2.5 x ULN, TBIL<1.5 x ULN
  -  Renal function: creatinine < 1.5 x ULN
  -  No immuno-deficiency
  -  Use of an effective contraceptive for adults to prevent pregnancy.
  Exclusion Criteria:
  -  Complete esophageal obstruction
  -  Deep esophageal ulcer
  -  Esophageal perforation
  -  Haematemesis
  -  After surgery, exploratory thoracotomy, radiotherapy, chemotherapy, or targeting therapy
  -  Esophageal stent or tracheal stent placed
  -  Other malignant tumors, except for skin basal cell carcinoma, or cervical carcinoma in situ, who survived with no evidence disease for over 3 years
  -  Participation in other interventional clinical trials within 30 days
  -  Pregnant or breast-feeding women or people during the birth-period who refused to take contraceptives
  -  Drug addiction
  -  Alcoholism or AIDS
  -  Uncontrolled seizures or psychiatric diseases, loss of control over their own behavior
  -  History of serious allergic or allergy
  -  Patients who are not suitable to participate in the trial according to researchers.

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

Clinical trial: Different Genetic Features Associated With Hepatic Carcinogenesis

Summary: The purpose of this study is to identify different genetic features in hepatocellular carcinoma. It will assist in predicting individual risks of disease progression and would help to clarify pathophysiological mechanisms of HCC.

Detailed description: Hepatocellular carcinoma (HCC) is a leading cause of cancer deaths in Taiwan. HCC normally develops as a consequence of underlying liver disease and is most often associated with cirrhosis. Surgical resection and liver transplantation are current best curative options to treat HCC. However, recurrence or metastasis is quite common in patients who have had a resection and survival rate is 30% to 40% at 5 years postoperatively.
  MicroRNAs, small non-coding RNA, act as endogenous RNA interference by post-transcription regulation. Recent studies suggest that microRNAs may act as tumor suppressors or oncogenes and altered microRNA expression levels may play an important role in the cancer initiation and progression. Several studies, including ourselves, have shown that specific microRNAs are aberrantly expressed in malignant HCC tissues compared to normal counterpart. Although many microRNA profiling studies were done to diagnose hepatocarcinogenesis, data about prognostic significances for postsurgical survival are very limited. The main point of this study is to develop a predictive signature for postsurgical survival in HCC patients.

Eligibility: Inclusion Criteria:
  -  clinical diagnosis of hepatocellular carcinoma
  Exclusion Criteria:

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

Clinical trial: Pancreas-sparing Duodenectomy Versus Pancreatoduodenectomy for Early-stage Periampullary Carcinoma

Summary: The purpose of this study is to investigate the feasibility, safety, and long-term prognosis of pancreas-sparing duodenectomy with regional lymphadenectomy in the treatment of early-stage (pTis/pT1/pT2) periampullary carcinoma with or without lymph node metastasis

Detailed description: Pancreaticoduodenectomy (PD) is commonly used for periampullary carcinoma (PC). In recent years, morbidity and mortality rates following PD have decreased, but the operative stress induced by pancreatectomy is considerable. Less-invasive surgery should thus be elected for PC without pancreatic and diffuse lymph node involvement. From the perspective of organ-preserving resection, pancreas-sparing duodenectomy (PSD) represents an attractive option for selected periampullary tumors, and offers an alternative to PD.
  Previous reports have described PSD for benign, premalignant and some selected malignant conditions of duodenum, and have emphasized this procedure as a safe and effective treatment associated with good quality of life. However, use of PSD for PC is still controversial.Available data about PSD for PC and published data from the follow-up evaluation in the literature are still limited.
  Given the fact that 20%-60% pT1/pT2 patients have regional lymph node metastasis, regional lymph node dissection should be essential for PC. However, lymphadenectomy has never been promoted as a regular procedure of PSD.The aim of the present study was to investigate the feasibility, safety, and long-term results of PSD with regional lymphadenectomy for early-stage (pTis/pT1/pT2) periampullary cancers.

Eligibility: Inclusion Criteria:
  -  Pathologically proven periampullary carcinoma (including cancers of distal common bile duct, ampulla or papilla of Vater)
  -  Pre- and intra-operative stage(CT, EU stage):pTis or pT1 or pT2, N0 or N1, M0
  -  ASA score: < 3
  -  Liver function:Child-Pugh A
  -  No history of other cancers
  -  No history of preoperative chemotherapy or radiotherapy
  -  Written informed consent
  Exclusion Criteria:
  -  There are concurrent cancers or the patients have been treated due to other type of cancers before diagnosed as periampullary carcinoma
  -  Pre- and intra-operative stage: more advanced than T2,or with remote metastasis
  -  The Patients received other non-surgical therapy, such as chemotherapy, immunotherapy, radiotherapy or endoscopic therapy
  -  The Patients received upper abdominal surgery
  -  ASA score: ≥ 3
  -  Liver function:Child-Pugh B or C
  -  Pregnancy patients

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

Clinical trial: Study of AUY922 and Cetuximab in Patients With KRAS Wild-Type Metastatic Colorectal Cancer

Summary: The study will determine the maximum tolerated dose (MTD) of AUY922 given in combination with cetuximab in previously treated patients with KRAS wild-type metastatic colorectal cancer.


Eligibility: Inclusion Criteria:
  -  Histologically or cytologically confirmed colorectal cancer
  -  KRAS wild type metastatic colorectal cancer
  -  Progression of disease on at least 2 prior therapy to have included 5FU, or oxaliplatin or bevacizumab or irinotecan
  -  Prior treatment with cetuximab is allowed (full dose tolerated), provided that the patient never required a dose reduction due to toxicities
  -  Must have at least one measurable lesion
  -  Must be 18 years of age or older
  -  ECOG performance status 0-1
  -  Life expectancy must be greater than 12 weeks
  -  For women of childbearing potential, a negative pregnancy blood test must be obtained less than 3 days prior to the first AUY922 infusion
  Exclusion Criteria:
  -  Colorectal cancer with a KRAS mutation or in which the KRAS genotype status is unknown
  -  Metastasis to the CNS
  -  Prior treatment with any Hsp90 inhibitor compounds
  -  Patients who received systemic anti-cancer treatment prior to the first dose of AUY922 within the following time frames:
  -  Radiotherapy, conventional chemotherapy: within 2 weeks
  -  Palliative radiotherapy: within 2 weeks
  -  Nitrosoureas, monoclonal antibodies, such as trastuzumab and mitomycin: within 6 weeks
  -  Any continuous-dosing (i.e. daily dosing, every-other-day dosing, Monday-Wednesday-Friday dosing, weekly etc.) of systemic anti-cancer treatment for which the recover period is not known, or investigational drugs (i.e. targeted agents) within a duration of ≤ 5 half lives of the agent and their active metabolites (if any)
  -  Treatment of therapeutic doses of coumadin-type anticoagulants. [Maximum daily dose of 2mg, for line patency permitted]
  -  Known sensitivity to cetuximab
  -  Unresolved ≥ grade 1 diarrhea
  -  Malignant ascites that require invasive treatment
  -  Concurrent medications that are substrates, inhibitors or inducers of CYP3A4, CYP2C8, CYP2C9 and CYP2C19 and cannot be switched or discontinued or switched to an alternative drug prior to commencing AUY922 dosing need special consideration on a case by case basis
  -  Major surgery ≤ 2 weeks prior to randomization or who have not recovered from such therapy
  -  Impaired cardiac function

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

Clinical trial: Economisation of Whipple Resection Using an Ultrasonic Dissection Device

Summary: Including 150 randomised patient, the studies aim is to determine whether an economisation and/or improvement in terms of operating time, drainage fluid, blood loss, time of hospitalisation can be found using an ultrasonic dissection device versus traditional surgical methods such as stitches an ligations.The study is performed for patients undergoing partial pancreatoduodenectomy.


Eligibility: Inclusion Criteria:
  resectable tumor
  Exclusion Criteria:
  palliative resection

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

Clinical trial: Retrospective Analysis Of Progression Free Survival And Overall Survival In A National Cohort Of Patients With Metastatic Renal Cell Carcinoma Treated In Denmark From 2006-2010. DARENCA Study 2.

Summary: Non-interventional study. Data obtained by patient chart reviews.
  Retrospective analysis of progression free survival, time to treatment failure and overall survival in a national cohort of patients with metastatic renal cell carcinoma treated in Denmark from 2006-2010 Safety, prognostic factors, predictive factors and co-morbidity assessed by Charlson Comorbidity Index.
  The following drugs will be evaluated: Sunitinib, Sorafenib, Temsirolimus, Everolimus, Aldesleukin, Interferon-alfa-2b.

Detailed description: No sampling. All eligible patients will be included.

Eligibility: Inclusion Criteria:
  Metastatic renal cell carcinoma
  Exclusion Criteria:

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

Clinical trial: Concurrent Induction Chemoimmunotherapy With Epirubicine, Oxaliplatin, Capecitabine and Panitumumab in KRAs Wild-type, Resectable Type II Gastric Adenocarcinoma

Summary: This is an open label, multicenter, single-arm phase II trial with primary eqirubicine-oxaliplatin-capecitabine chemotherapy and concurrent Pmab in patients with resectable, histologically proven gastric or esophageal cancer.


Eligibility: Inclusion Criteria:
  -  Untreated, histologically confirmed, KRAS wild type, resectable gastric or esophageal adenocarcinoma
  -  T2-4 NX M0 disease
  -  ECOG performance status 0-1
  -  adequate hematological status
  -  adequate renal function
  -  adequate hepatic function
  -  adequate metabolic function
  Exclusion Criteria:
  -  pregnant or breast feeding women
  -  previous malignancy other than gastric cancer in the last 5 years except curatively treated basal cell carcinoma of the skin and/or in situ carcinoma of the cervix
  -  arterial or venous thromboembolism within 6 months before enrollment
  -  clinically significant cardiovascular disease within 1 year before enrollment
  -  history of interstitial lung disease

Relevance to patient case: not relevant