araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 57-year-old female with Pancreatic adenocarcinoma. Genetic variant: RB1, TP53, KRAS. Other conditions: None.

Clinical trial: Palliative Stereotactic Radiation for Pancreatic or Periampullary Adenocarcinoma

Summary: The investigators are looking to see if a certain dose of stereotactic body radiation therapy (SBRT) may be a viable treatment option for recurrent or residual pancreatic or periampullary adenocarcinoma.

Detailed description: No standard treatment option has yet been established for patients with recurrent or residual disease after definitive treatment of pancreatic or periampullary cancers (duodenal, ampullary, bile duct). Linac based stereotactic body radiation therapy (SBRT) administered in 1-3 fractions has been shown to be an effective treatment option for patients with unresectable, locally advanced pancreatic adenocarcinoma, achieving local control rates of 84-92% at one year. Associated late gastrointestinal toxicity rates have been reported to be 22-25% at 1 year. We hypothesize that similarly excellent local control rates (80-90% at one year) with a reasonable rate of toxicity (≤20%) can be achieved using Linac based SBRT delivered as 5 Gy x 5 for patients with local failure (remaining disease) after previous treatment with conventional chemoradiation therapy (CRT) with or without surgery and as 6.6 Gy x 5 for radiation-naïve patients with local failure (remaining disease) after previous treatment with surgery and/or chemotherapy. The toxicities of note for this trial are grade 2 and greater gastritis, fistula, enteritis, ulcer, or any other grade 3 or greater gastrointestinal toxicity.

Eligibility: Inclusion Criteria:
  -  18 years of age or older
  -  Karnofsky Performance Status greater than or equal to 70%
  -  confirmed pancreatic or periampullary adenocarcinoma
  -  pancreatic or periampullary tumor less than 8.0 cm in greatest axial dimension
  -  Either:
  -  standard of care treatment for pancreatic cancer that included radiation therapy
  * patients may be receiving continued chemotherapy post initial CRT. or
  -  standard of care treatment for pancreatic cancer that did not include radiation therapy * patients must have attempted chemotherapy upon initial diagnosis
  -  acceptable organ and marrow function as determined by blood tests
  -  ability to understand and give consent
  -  must be a patient to be treated with SBRT only at Johns Hopkins Hospital
  -  life expectancy of greater than 3 months
  Exclusion Criteria:
  -  extensive metastatic disease
  -  performance status of less than 70
  -  children are excluded form the study
  -  no uncontrolled intercurrent illness
  -  no concurrent malignancy other than melanoma
  -  pregnant or breast feeding women are excluded
  -  women who are not post-menopausal and have a positive pregnancy test
  -  life expectancy of less than 3 months

Relevance to patient case: not relevant
Patient case: 57-year-old female with Pancreatic adenocarcinoma. Genetic variant: RB1, TP53, KRAS. Other conditions: None.

Clinical trial: EUS-guided Intratumoral Gemcitabine in Locally Advanced Unresectable Pancreatic Cancer

Summary: Pancreatic cancer is the 11th most common type of cancer but it is the fourth leading cause of cancer death. The only effective treatment for pancreatic cancer includes surgery. However, only 20% of the patients have surgically treatable disease. Also, the 5-year survival for the surgically treated patients is only 15%.
  About 40% of the patients present with advanced disease with distant metastasis, and the remaining 40% present with locally advanced unresectable cancer with the tumor invaded into surrounding major vessels. For those with locally advanced disease, systemic chemotherapy with or without radiotherapy provides palliation of the symptoms but cannot cure the disorder. Systemic chemotherapy is given through peripheral vessels.
  The investigators hypothesized that direct injection of the chemotherapeutic drug into the tumor may help to boost the effect of systemic chemotherapy and radiotherapy in those with locally advanced pancreatic cancer.

Detailed description: In this study, gemcitabine will be injected directly into the tumor by means of endoscopic ultrasound (EUS) in the eligible patients.

Eligibility: Inclusion Criteria:
  -  Patients with histologically verified pancreatic adenocarcinoma who have locally advanced unresectable tumor
  Exclusion Criteria:
  -  Early stage resectable pancreatic cancer with the intact surrounding major vessels on imaging
  -  Pancreatic cancer with distant metastasis
  -  Unwilling to sign informed consent

Relevance to patient case: not relevant
Patient case: 57-year-old female with Pancreatic adenocarcinoma. Genetic variant: RB1, TP53, KRAS. Other conditions: None.

Clinical trial: A Randomized Phase II/Genomic Trial of Two Chemotherapy Regimens in Patients With Resected Pancreatic Adenocarcinoma

Summary: Determine the relapse-free survival of resected pancreatic cancer patients following two novel regimens with activity in advanced disease.

Detailed description: The objective of this study are to determine the relapse-free survival of resected pancreatic cancer patients following two novel regimens. The secondary objectives are 1) to assess the toxicity of each of these regimens in this setting. 2) To perform exploratory genomic analyses as a means of assessing molecular characteristics potentially associated with risk of relapse with one or both of the regimens. 3) To determine the relationship between known mutations and metabolic activity as measured by FDG-PET and risk of relapse.

Eligibility: Inclusion Criteria:
  -  Patients must have histologically or cytologically confirmed evidence of pancreatic carcinoma.
  -  Patients must have had all gross disease resected (R0 or R1 resection).
  -  Patients who underwent an R2 resection are not eligible.
  -  Patients must have had no prior chemotherapy or radiation therapy for pancreatic cancer.
  -  Age > 18 years.
  -  Patient must have ECOG performance status of 0-2.
  -  Patients must have normal organ and marrow function measured within 2 weeks. prior to registration as follows:
  ANC > 1,500/µL Platelets > 100,000/µL Total bilirubim less than 2-fold ULN AST(SGOT)/ALT(SGPT)<2.5X institutional upper limit of normal Creatinine clearance > 60mL/min for patients with creatinine levels above institutional normal.
  -  Patients must be > 4 weeks and < 12 weeks post-surgery at time of study registration.
  -  Women of childbearing potential and sexually active males are stronglt advised to use appropriate contraceptive measures.
  Women must not be pregnant or breast-feeding. All agents used in this study as well as radiation therapy to the abdomen have the potential for teratogenic or abortifacient effects. All females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy.
  -  Patients must not be receiving any other investigational agents.
  -  Patients with known metastases are not eligible.
  -  Patients with wounds that have not fully healed are not eligible.
  Exclusion Criteria:

Relevance to patient case: not relevant
Patient case: 57-year-old female with Pancreatic adenocarcinoma. Genetic variant: RB1, TP53, KRAS. 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: 57-year-old female with Pancreatic adenocarcinoma. Genetic variant: RB1, TP53, KRAS. Other conditions: None.

Clinical trial: Efficacy Study of Lucentis in the Treatment of Retinoblastoma

Summary: This study will evaluate the clinical efficacy of intravitreal injections of Ranibizumab (Lucentis) together with chemotherapy in the treatment of Retinoblastoma as compared to chemotherapy alone.

Detailed description: This study will be a phase II open label interventional case series. Patients with retinoblastoma will be randomized to receive chemotherapy with or without intravitreal ranibizumab at a dose of 0.5mg/0.05 ml. Patients will receive ranibizumab via a pars plana injection on a monthly basis for a total duration of therapy of 6 months. Patients will be followed for 24 months .

Eligibility: Inclusion Criteria:
  -  Ability to provide written informed consent and comply with study assessments for the full duration of the study.
  -  Definite characteristic signs of retinoblastoma,Group D base on Intraocular International Retinoblastoma classify, IIRC.
  Exclusion Criteria:
  -  History of surgical intervention for retinoblastoma in the study eye.
  -  Any previous disease in the study eye.
  -  Previous participation in any studies of investigational drugs within 1 month preceding Day 0 (excluding vitamins and minerals).
  -  Previous participation in a clinical trial (for either eye) involving anti angiogenic drugs (pegaptanib, ranibizumab, anecortave acetate, protein kinase C inhibitors, etc.)

Relevance to patient case: not relevant
Patient case: 57-year-old female with Pancreatic adenocarcinoma. Genetic variant: RB1, TP53, KRAS. Other conditions: None.

Clinical trial: Adjuvant Chemotherapy for High-risk Retinoblastoma After Enucleation

Summary: The purpose of this study is to determine whether 3 cycles of chemotherapy(CEV) are as effective as 6 cycles of chemotherapy(CEV) in the treatment of Stage I enucleated retinoblastoma.

Detailed description: This study will be a phase Ⅲ open label interventional case series. Patients with Stage I enucleated retinoblastoma will be randomized to receive chemotherapy(CEV) of 3 cycles or 6 cycles on a monthly basis. Patients will be followed for 24 months.

Eligibility: Inclusion Criteria:
  -  Ability to provide written informed consent and comply with study assessments for the full duration of the study.
  -  Definite pathology signs of retinoblastoma, Stage I base on International Retinoblastoma Staging System.
  -  Received enucleation in the study eye.
  -  Monocular retinoblastoma.
  Exclusion Criteria:
  -  Any previous disease in the study eye.
  -  Previous participation in any studies of investigational drugs within 1 month preceding Day 0 (excluding vitamins and minerals).
  -  History of chemical intervention for retinoblastoma in the study eye.

Relevance to patient case: not relevant
Patient case: 57-year-old female with Pancreatic adenocarcinoma. Genetic variant: RB1, TP53, KRAS. 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: 57-year-old female with Pancreatic adenocarcinoma. Genetic variant: RB1, TP53, KRAS. 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: 57-year-old female with Pancreatic adenocarcinoma. Genetic variant: RB1, TP53, KRAS. 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: 57-year-old female with Pancreatic adenocarcinoma. Genetic variant: RB1, TP53, KRAS. 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: 57-year-old female with Pancreatic adenocarcinoma. Genetic variant: RB1, TP53, KRAS. 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: 57-year-old female with Pancreatic adenocarcinoma. Genetic variant: RB1, TP53, KRAS. 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