araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 49-year-old female with Pancreatic adenocarcinoma. Genetic variant: KRAS, TP53. Other conditions: None.

Clinical trial: LOTCOL Study: Local Treatment of Colo-rectal Liver Met

Summary: In this study the investigators will include colo-rectal cancer (CRC) patients starting last line of standard palliative chemotherapy. Eligible patients include patients with KRAS mutation starting line or KRAS wild type starting line treatment. Standard treatment today for these patients is chemotherapy only and median overall survival (OS) is about 10 months. The hypothesis is that local treatment in addition to systemic treatment will increase time to progression, progression free survival and overall survival compared to patients who receive systemic chemotherapy only. The investigators experience with local treatment of liver metastases in CRC patients is that side-effects of treatment in general are minor, although gastric bleeding have been observed after stereotactic body radiation therapy.


Eligibility: Inclusion Criteria:
  -  Histologically verified adenocarcinoma of colon or rectum
  -  Ambulatory with an ECOG performance status 0-2
  -  At least 18 years of age
  -  Non-resectable liver metastases
  -  Progressive disease on or within 4 months after 1.line chemotherapy for KRAS mutant or after 2.line chemotherapy in KRAS wild type patients
  -  1-4 liver metastases with largest diameter of up to 6 cm on CT-scan
  -  Up to 20 lesions in liver with no more than 4 lesions larger than 4 cm
  -  The patients will start 2./3. line chemotherapy (KRAS mutant/KRAS wt)
  -  Laboratory values as the following:
  -  ANC ³ 1.5 x 109/L
  -  Platelets ³ 100 x 109/L
  -  Hb ³ 9g/dL
  -  Creatinine £ 2x upper limit of normal
  -  Bilirubin < 2.0x the upper limit of normal
  -  ASAT and ALAT £ 5x the upper limit of normal
  -  Albumin levels > 30 g/L
  -  INR<1.3
  -  Signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to ICH GCP, and national/local regulations
  Exclusion Criteria:
  -  Previous treatment with 2. or 3. line chemotherapy (KRAS mutant/KRAS wt)
  -  History of prior metastatic disease the last 3 years
  -  History of CNS or bone metastases
  -  Significant cardiac or other medical illness that would limit activity or survival, such as severe congestive heart failure, unstable angina, or serious cardiac arrhythmia
  -  Largest liver mets >6 cm, more than 4 liver lesions >4 cm
  -  Pulmonary mets>3 cm
  -  Lymph node mets >2.5 cm
  -  Chemotherapy/radiation therapy or major surgery within the last 4 weeks before start of treatment
  -  Any reason why, in the opinion of the investigator, the patient should not participate.

Relevance to patient case: not relevant
Patient case: 49-year-old female with Pancreatic adenocarcinoma. Genetic variant: KRAS, TP53. Other conditions: None.

Clinical trial: A Phase 2, Multicenter Study of FOLFIRINOX Followed by Ipilimumab With Allogenic GM-CSF Transfected Pancreatic Tumor Vaccine in the Treatment of Metastatic Pancreatic Cancer

Summary: This study will enroll patients who have metastatic pancreatic cancer with stable disease on FOLFIRINOX chemotherapy. The main purpose of this study is to compare survival between patients that receive ipilimumab and a pancreatic tumor vaccine and patients who continue to receive FOLFIRINOX.
  Funding Source - FDA OOPD


Eligibility: Inclusion Criteria (abbreviated):
  1. Documented adenocarcinoma of the pancreas
  2. Stable metastatic pancreatic cancer after 8-12 doses of FOLFIRINOX
  3. ECOG performance status of 0 or 1
  4. Life expectancy greater than 3 months
  5. Adequate organ and marrow function defined by study-specified laboratory tests.
  6. Must use acceptable form of birth control while on study
  7. Oxygen saturation on room air >92%
  Exclusion Criteria (abbreviated):
  1. Surgery within 4 weeks of dosing investigational agent (some exceptions for minor procedures)
  2. Off FOLFIRINOX treatment for more than 70 days prior to treatment on study
  3. Prior chemotherapy for metastatic pancreatic cancer (other than FOLFIRINOX or adjuvant therapy).
  4. History of prior treatment with ipilimumab, anti-PD1 antibody, CD137 agonist, or anti-CD40 antibody
  5. Received any non-oncology live vaccine therapy up to one month prior to or after any dose of ipilimumab/vaccine
  6. Receiving any other investigational agents
  7. Any of the following concomitant therapy: IL-2, interferon, immunosuppressive agents, or chronic use of systemic corticosteroids
  8. History of symptomatic autoimmune disease or immune impairment. Thyroid disease is allowed.
  9. Known brain metastasis
  10. Radiographic ascites that is apparent on physical exam or requiring intervention in the 2 months prior to enrollment
  11. Uncontrolled intercurrent illness
  12. Known or suspected hypersensitivity to GM-CSF
  13. Chronic HIV, Hepatitis B or Hepatitis C
  14. Pregnant or breastfeeding women

Relevance to patient case: not relevant
Patient case: 49-year-old female with Pancreatic adenocarcinoma. Genetic variant: KRAS, TP53. Other conditions: None.

Clinical trial: Assess Efficacy & Safety of Selumetinib in Combination With Docetaxel in Patients Receiving 2nd Line Treatment for v-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Positive NSCLC

Summary: The purpose of this study is to assess the efficacy of selumetinib in combination with docetaxel (75mg/m2) vs placebo in combination with docetaxel (75mg/m2) in patients with locally advance or metastatic NSCLCs that harbor mutations of KRAS. This study will also assess the PK, safety, patient reported outcomes (PRO) and tolerability profile of the selumetinib/docetaxel combination, compared to placebo in combination with docetaxel

Detailed description: A Phase III, Double-Blind, Randomised, Placebo-Controlled Study to Assess the Efficacy and Safety of Selumetinib (AZD6244; ARRY-142886) (Hyd-Sulfate) in Combination with Docetaxel, in Patients receiving second line treatment for KRAS Mutation-Positive Locally Advanced or Metastatic Non Small Cell Lung Cancer (Stage IIIB - IV) (SELECT-1)

Eligibility: Inclusion Criteria:
  -  Provision of signed, written and dated informed consent prior to any study specific procedures
  -  Male or female, aged 18 years or older
  -  Histological or cytological confirmation of locally advanced or metastatic NSCLC (IIIB-IV)
  -  KRAS mutation positive tumour sample as determined by the designated testing laboratory
  -  Failure of 1st line anti-cancer therapy due to radiological documentation of disease progression in advanced disease or subsequent relapse of disease following 1st line therapy
  Exclusion Criteria:
  -  Mixed small cell and non-small cell lung cancer histology.
  -  Received >1 prior anti-cancer drug regimen for advanced or metastatic NSCLC. Patients who develop disease progression while on switch maintenance therapy (maintenance using an agent not in the first-line regimen) will not be eligible.
  -  Receiving or have received systemic anti-cancer therapy within 30 days prior to starting study treatment
  -  Other concomitant anti-cancer therapy agents excepts steroids
  -  Prior treatment with a Mitogen-Activated protein Kinase (MEK) inhibitor or any docetaxel-containing regimen (prior treatment with paclitaxel is acceptable).
  -  Last radiation therapy within 4 weeks prior starting study treatment, or limited field of radiation for palliation within 7 days of the first dose of study treatment

Relevance to patient case: not relevant
Patient case: 49-year-old female with Pancreatic adenocarcinoma. Genetic variant: KRAS, TP53. Other conditions: None.

Clinical trial: Prognostic Value of the Marker P63 in Adenocarcinoma of Lung, Breast, and Pancreas

Summary: The p63 gene is a recently discovered member of the p53 family located at chromosome 3q27Many studies have reported that overexpression of p63 can mimic p53 activities by binding DNA, activating transcription, and inducing apoptosis.
  Various studies proved p63 as a marker of basal cells in normal salivary glands, breast, prostate, respiratory and squamous epithelia, and of tumor cells from various malignancies. Still, p63 has been the subject of relatively few studies in lung adenocarcinoma, and breast carcinoma, and no study has described the correlation of p63 with pancreatic ductal adenocarcinoma.
  In the current study, we aim to evaluate the prognostic value of the expression of p63 in the lung adenocarcinoma, breast adenocarcinoma, and pancreatic ductal adenocarcinoma. We will achieve this aim by collecting clinical data retrospectively from the patients' medical records as well as assessing the histological sections and performing immunohistochemical staining for p63.


Eligibility: Inclusion Criteria:
  -  Patients who were treated at our institution for lung adenocarcinoma, breast adenocarcinoma, or pancreatic ductal adenocarcinoma.
  -  Available histopathological diagnosis of the malignancy.
  Exclusion Criteria:
  -  Patients with inoperable tumors.
  -  Patients with second primary tumor.
  -  Patients with pathological blocks not enough for future slicing.

Relevance to patient case: possibly relevant
Patient case: 49-year-old female with Pancreatic adenocarcinoma. Genetic variant: KRAS, TP53. Other conditions: None.

Clinical trial: PAncreatic Adenocarcinoma in Hospital

Summary: Few data are currently available in the literature on pancreatic adenocarcinoma in France. About 8,000 new cases each year in France. The 5-year survival for all stages combined is <5%. This is the only digestive cancer in which mortality / incidence ratio is 98%.
  Epidemiological characteristics at diagnosis, the impact on the survival of recent advances related to surgery, adjuvant chemotherapy and new standard forms of adjuvant chemotherapy (FOLFIRINOX) are mispriced in real life.
  The development of new drugs and the development of Phase II and III require a better understanding of the state of this disease in the country.
  The main objective is to describe the characteristics of the pancreatic adenocarcinoma at diagnosis in France and make an inventory of diagnostic practices and support.


Eligibility: Inclusion Criteria:
  -  Living in France
  -  Pancreatic adenocarcinoma histologically or cytologically proven
  -  primary diagnosis
  -  Agreed to participate
  Exclusion Criteria:
  -  Suspected pancreatic adenocarcinoma histologically or cytologically unproven
  -  Refused to participate

Relevance to patient case: not relevant
Patient case: 49-year-old female with Pancreatic adenocarcinoma. Genetic variant: KRAS, TP53. Other conditions: None.

Clinical trial: Dexmedetomidine for Catheter-related Bladder Discomfort

Summary: To evaluate the efficacy of dexmedetomidine for the prevention of catheter-related bladder discomfort

Detailed description: After transurethral bladder resection, large-sized foley catheter have been used for drainage of urine and residual blood. Because of urinary catheterization, patients usually experiences catheter-related bladder discomfort defined as a burning sensation with an urge to void or discomfort in the supra-pubic region caused by catheter- related bladder irritation.
  Dexmedetomidine is an alpha-2 antagonist and used as an analgesic agent. The investigators try to evaluate The efficacy of dexmedetomidine for the treatment of catheter-related bladder discomfort

Eligibility: Inclusion Criteria:
  -  Patients scheduled for transurethral bladder resection
  -  ASA I-III
  Exclusion Criteria:
  -  Patient who disagrees to participate this investigation
  -  Patient with severe cardiovascular disease
  -  Patient with small-sized foley catheter (less than 18 Fr.)
  -  Patinets with any urinary tract obstructions
  -  Patient with hyperactive or neurogenic bladder
  -  Patients with chronic renal failure
  -  Patient with morbidly obese
  -  Patients with neurogenic disorder
  -  Patient with medications for chronic pain

Relevance to patient case: not relevant
Patient case: 49-year-old female with Pancreatic adenocarcinoma. Genetic variant: KRAS, TP53. Other conditions: None.

Clinical trial: The Cancer of the Pancreas Screening-5 CAPS5)Study

Summary: Johns Hopkins clinical research office quality assurance group will monitor and audit this study at Johns Hopkins. The Sub Investigator at each site will be responsible for internal monitoring at their site.

Detailed description: The Sub Investigator at each site will be responsible for internal monitoring at their site. The site sub Investigator and study team will report any serious adverse events to Principal Investigator and annually report adverse events.

Eligibility: Inclusion Criteria:
  -  Hereditary Pancreatitis or
  -  Peutz-Jeghers Syndrome or
  -  Strong family history of pancreas cancer on one side of the family tree or
  -  Confirmed germline mutation carrier (BRCA2, FAMMM, PALB2, BRCA1, HNPCC, PRSS1/2, or CTRC
  -  Endoscopic evaluation of pancreas scheduled
  Exclusion Criteria:
  -  Medical comorbidities or coagulopathy that contraindicate endoscopy
  -  Prior surgery that prevent optimal endoscopic ultrasound such as partial or complete gastrectomy with Bilroth or Roux-en-Y anastomosis
  -  Stricture or obstruction in the upper GI tract that does not allow passage of the echoendoscope
  -  Poor performance status
  -  Inability to provide informed consent
  -  Pregnancy.

Relevance to patient case: not relevant
Patient case: 49-year-old female with Pancreatic adenocarcinoma. Genetic variant: KRAS, TP53. Other conditions: None.

Clinical trial: Combination of Icotinib and Gemcitabine as First-line Treatment in Pancreatic Cancer

Summary: Research Hypothesis: icotinib administered in combination with gemcitabine has an acceptable safety profile in subjects with locally advanced, unresectable or metastatic pancreatic adenocarcinoma.The primary objective is to determine the safety profile of icotinib in combination with gemcitabine in subjects with locally advanced, unresectable or metastatic pancreatic adenocarcinoma.


Eligibility: Inclusion Criteria:
  -  Locally advanced, unresectable or metastatic pancreatic cancer by histologic or cytologic confirmation without previous chemotherapy or target therapy.
  -  ECOG Performance Status of 0 to 1.
  -  Adequate organ function as defined by study-specified laboratory tests.
  -  Signed informed consent form.
  -  Willing and able to comply with study procedures.
  Exclusion Criteria:
  -  Previous chemotherapy or target therapy.
  -  Currently have or have history of certain study-specified heart, liver, kidney, lung, neurological, immune or other medical conditions.
  -  Systemically active steroids.
  -  Another investigational product within 28 days prior to receiving study drug.
  -  Major surgery or significant traumatic injury (or unhealed surgical wounds) occurring within 28 days prior to receiving study drug.
  -  Infection with HIV, hepatitis B or C at screening.
  -  Pregnant or lactating.
  -  Conditions, including alcohol or drug dependence, or intercurrent illness that would affect the patient's ability to comply with study visits and procedures.

Relevance to patient case: not relevant
Patient case: 49-year-old female with Pancreatic adenocarcinoma. Genetic variant: KRAS, TP53. Other conditions: None.

Clinical trial: Evaluation of PET/MRI in Patients With Pancreatic Adenocarcinoma

Summary: This study will use PET/MRI in patients with adenocarcinoma of the pancreas to identify hidden metastatic disease or identify patients with borderline or locally advanced disease.

Detailed description: Patients will receive a PET/MRI scan within 6 weeks of their standard of care imaging. There is no maximum number of scans for research. The number of scans depends on each patient's treatment plan.

Eligibility: Inclusion Criteria:
  -  Presence of suspicious lesion of the pancreas consistent with pancreatic adenocarcinoma. Cytological confirmation is not required.
  -  Patients preparing to receive therapy for pancreas cancer, including patients enrolled in NCT01413022
  -  Patient must be 18 years or older
  -  Patient must have a life expectancy of more than 6 months and performance status of 2 or less
  -  Patient must be able to understand and willing to sign an approved written informed consent document
  -  Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the length of the study
  -  Patients enrolled in the Clinical trials.gov# NCT01413022 trial must meet both studies eligibility criteria.
  Exclusion Criteria:
  -  Patient must not have had prior resection for pancreatic adenocarcinoma.
  -  Patient must not have a history of other malignancy less than or equal to 5 years previous with the exception of basal cell or squamous cell carcinoma of the skin which were treated with local resection only or carcinoma in situ of the cervix
  -  Patient must not be unable to receive a PET-MRI scan due to renal function, allergy or other problem with receiving or tolerating an MRI scan, etc. All patients will fill out a standard MRI screening form.
  -  Patients must not have a blood glucose of greater than or equal to 200mg/dL at the time of PET-MRI or if a patient is diabetic and glucose is not controlled. At the discretion of the PI and the authorized user and with their approval prior to 2-[18]fluoro-2-deoxy-D-glucose (FDG) injection, patients with blood glucose ≥ 200 mg/dL may participate in the study.
  -  Patient must not be pregnant and/or breast feeding

Relevance to patient case: not relevant
Patient case: 49-year-old female with Pancreatic adenocarcinoma. Genetic variant: KRAS, TP53. Other conditions: None.

Clinical trial: mFOLFIRINOX as First-Line Chemotherapy in Treating Chinese Patients With Metastatic Pancreatic Cancer

Summary: This phase Ⅱ study was designed to evaluate the efficacy and safety of mFOLFIRINOX as first-line treatment for metastatic pancreatic cancer in China.

Detailed description: Although FOLFIRINOX regimen was recently presented to be effective for metastatic pancreatic cancer in selected patients who have good physical condition, there is still insufficient evidence on this regimen in treating patients with metastatic pancreatic cancer in China. Since for many tumors, different races may show different responses to the same regimen, we design this open, multicenter phase Ⅱ study to evaluate the the efficacy and safety of mFOLFIRINOX as first-line treatment for metastatic pancreatic cancer in China.

Eligibility: Inclusion Criteria:
  -  Patients have provided a signed Informed Consent Form
  -  ECOG performance status of 0-1
  -  BMI ≥ 18.5
  -  Age: 18-65 years old
  -  Histologically confirmed diagnosis of metastatic pancreatic cancer
  -  No prior palliative chemotherapy
  -  Measurable disease in at least 1 diameter by CT scan or MRI as per RECIST 1.1 criteria
  -  Life expectancy ≥ 3 months
  -  Patient has adequate bone marrow and organ function
  -  Absolute Neutrophil Count (ANC) ≥ 2.0 x 109/L
  -  Platelets ≥ 90 x 109/L
  -  Hemoglobin ≥ 90 g/L
  -  Patient has adequate liver function
  -  AST and ALT not more than 2.5 times ULN (not more than 5.0 times ULN if there is liver metastasis)
  -  Serum bilirubin ≤ 1.2 x ULN
  -  Creatinine ≤ 1.25 times ULN
  -  Good compliance
  Exclusion Criteria:
  -  Pregnant or lactating women
  -  Brain metastasis or only with bone metastasis.
  -  Patients with severe gastrointestinal hemorrhage which need frequent blood transfusions.
  -  Refuse to take appropriate contraceptive measures (including male patients).
  -  Allergic to Oxaliplatin, Irinotecan, Leucovorin or 5-Fluorouracil.
  -  Severe systemic disease out of control such as unstable or uncompensated respiratory, cardiac, liver, renal diseases.
  -  Patient has a concurrent malignancy or has a malignancy within 5 years of study enrollment, (with the exception of non-melanoma skin cancer or cervical carcinoma in situ).
  -  Psychiatric illness that would prevent the patient from giving informed consent.
  -  Patient is concurrently using other antineoplastic agent
  -  Patient has used investigational antineoplastic agent within 4 weeks prior to entry.
  -  Known HIV-positivity.
  -  No history of chronic diarrhea, nausea or vomit.
  -  No ≥ grade 2 sensory peripheral neuropathy.
  -  A history of transmural myocardial infarction (within 6 months prior to entry), congestive heart failure, and unstable angina.
  -  Infectious disease or inflammation with body temperature ≥ 38 ℃.

Relevance to patient case: not relevant
Patient case: 49-year-old female with Pancreatic adenocarcinoma. Genetic variant: KRAS, TP53. Other conditions: None.

Clinical trial: Dacomitinib Plus PD-0325901 in Advanced KRAS Mutant Malignancies

Summary: This is a phase I/II multi-center open-label proof of concept study, consisting of two parts. Part A of this study is designed to identify the recommended phase 2 dose (RP2D) of the combination regimen of dacomitinib plus PD-0325901 in patients with advanced KRAS mutant (KRASm) colorectal cancer (CRC), non-small cell lung cancer (NSCLC), or pancreatic cancer. Part B is designed to perform a randomized comparison of the combination of dacomitinib and PD-0325901 versus standard of care therapy in patients with advanced KRASm CRC, NSCLC, or pancreatic cancer. It is hypothesized that with this combination strategy the progression free survival of patients with KRASm CRC, NSCLC or pancreatic cancer will be doubled.


Eligibility: Inclusion Criteria:
  -  Histological or cytological proof of advanced colorectal cancer (CRC), non-small cell lung cancer (NSCLC) or pancreatic cancer
  -  Written documentation of KRAS (exon 2, 3 or 4) mutation
  -  At least 18 years of age or older
  -  Able and willing to give written informed consent
  -  WHO performance status of 0 or 1
  Exclusion Criteria:
  -  Symptomatic or untreated leptomeningeal disease
  -  Symptomatic brain metastasis
  -  Impairment of gastrointestinal function
  -  Uncontrolled infectious disease
  -  Left ventricular ejection fraction < 50%
  -  Retinal degenerative disease or with history of uveitis, retinal vein occlusion or retinal detachment
  Other protocol-defined inclusion/exclusion criteria may apply

Relevance to patient case: not relevant