araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 48-year-old male with Pancreatic cancer. Genetic variant: CDK6 Amplification. Other conditions: None.

Clinical trial: EndoTAG-1 / Gemcitabine Combination Therapy to Treat Locally Advanced and/or Metastatic Adenocarcinoma of the Pancreas

Summary: The intention of this trial is to evaluate safety and efficacy of a combination treatment of EndoTAG-1 with Gemcitabine versus Gemcitabine monotherapy.


Eligibility: Inclusion Criteria:
  -  Inoperable adenocarcinoma of the pancreas
  -  Histologic or cytologic confirmation
  -  At least 18 years of age
  Exclusion Criteria:
  -  Any chemotherapeutical treatment for pancreatic adenocarcinoma before enrollment
  -  Major surgery within 4 weeks prior to enrollment
  -  Major cardiovascular disease

Relevance to patient case: not relevant
Patient case: 48-year-old male with Pancreatic cancer. Genetic variant: CDK6 Amplification. Other conditions: None.

Clinical trial: A Phase II, Trial of Ixabepilone Plus Cetuximab as First Line Therapy for Metastatic Pancreatic Cancer

Summary: The purpose of this clinical research study is to learn if ixabepilone plus cetuximab improves survival when given as 1st line chemotherapy in subjects with metastatic pancreatic cancer compared to historical data. The safety of this combination treatment will also be studied.


Eligibility: Inclusion Criteria:
  -  Histologic or cytologic diagnosis of pancreatic adenocarcinoma (locally advanced disease that is not surgically resectable, or distant metastatic disease)
  -  Participants must have measurable disease as per Response Evaluation Criteria In Solid Tumors (RECIST) guidelines
  -  Participants must not have received prior chemotherapy, immunotherapy or chemoradiotherapy for advanced pancreas cancer
  -  Karnofsky performance status (KPS) of 70-100
  -  Adequate hematologic, hepatic and renal function

Relevance to patient case: not relevant
Patient case: 48-year-old male with Pancreatic cancer. Genetic variant: CDK6 Amplification. Other conditions: None.

Clinical trial: RAD001 in Previously Treated Patients With Metastatic Pancreatic Cancer

Summary: The purpose of this research study is to investigate if RAD001 is an effective treatment for pancreatic cancer that has spread and not responded to treatment. Experiments have shown that RAD001 can prevent cells from multiplying. RAD002 has also been tested in laboratory experiments imitating cancer conditions and the results have been promising.

Detailed description: -  Participants taking part in this research study will be given a study medication-dosing calendar for each treatment cycle. Each cycle lasts four weeks during which you will be taking the study drug, RAD001, orally every day.
  -  Participants will come into the clinic every other week during the time of enrollment. At each clinic visit blood work will be taken to monitor the participants health and a physical exam will be performed. CT scans will be repeated every 2 months to assess the tumor.
  -  Participants will remain on the study as long as they continue to benefit from the study medication.

Eligibility: Inclusion Criteria:
  -  Pathologic confirmation of pancreatic adenocarcinoma
  -  18 years of age or older
  -  At least one measurable site of disease according to RECIST criteria that has not been previously irradiated. If patient has had previous radiation to the marker lesion(s), there must be evidence of progression since the radiation.
  -  Treated with gemcitabine-based chemotherapy with documented tumor progression on gemcitabine or intolerance to gemcitabine.
  -  Prior treatment with no more than 1 prior chemotherapy regimen for metastatic disease.
  -  Minimum of two weeks since any major surgery, completion of radiation, or completion of all prior systemic anti-cancer therapy.
  -  ECOG performance status 0-1.
  -  Life expectancy of greater than 12 weeks.
  -  Adequate bone marrow and liver function.
  -  Must be able to swallow tablets.
  Exclusion Criteria:
  -  Prior treatment with an investigational drug within the preceding 4 weeks.
  -  Prior treatment with an inhibitor of mTOR
  -  Chronic treatment with systemic steroids or another immunosuppressive agent
  -  More than one prior chemotherapy treatment for metastatic disease
  -  Uncontrolled brain or leptomeningeal metastases, including patient who continue to require glucocorticoids for brain or leptomeningeal metastases.
  -  Other malignancies within the past 3 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin
  -  Patients with chronic renal insufficiency
  -  Other concurrent severe and/or uncontrolled medical disease which could compromise participation in the study.
  -  Known history of HIV seropositivity
  -  Impairment of gastrointestinal function or gastrointestinal disease that my significantly alter the absorption of RAD001.
  -  Active, bleeding diathesis or an oral vitamin K antagonist medication
  -  Women who are pregnant or breast feeding

Relevance to patient case: not relevant
Patient case: 48-year-old male with Pancreatic cancer. Genetic variant: CDK6 Amplification. Other conditions: None.

Clinical trial: Outcome of Pancreatic Stump Closure Following Resection of Tumors of the Head of the Pancreas.

Summary: Chart review evaluating outcome of patients in whom following resection of a tumor involving the head of the pancreas no anastomosis of the pancreatic stump was done to the gastrointestinal tract.


Eligibility: Inclusion Criteria:
  -  Pathologically proven carcinoma of the head of pancreas or other periampullary carcinoma treated by pancreaticoduodenectomy.
  Exclusion Criteria:
  -  Patients undergoing pancreaticoduodenectomy for other indications (i.e. trauma)
  -  Charts not available for review.

Relevance to patient case: not relevant
Patient case: 48-year-old male with Pancreatic cancer. Genetic variant: CDK6 Amplification. Other conditions: None.

Clinical trial: Proteomic Analysis of HLA Complex in Solid Cancers: Breast, Ovary, Colon, Rectum, Stomach, and Pancreas

Summary: The purpose of this study is to evaluate the presence of proteins in solid tumors which may lead to an immune response

Detailed description: The main objective of the study is to evaluate which proteins are presented by the HLA complex of solid tumors. Secondary objectives include to evaluate whether an immune response specific to these proteins has actually been provoked and whether there is a similar immune response following recurrence. Real specimens will be evaluated using PCR and mass spectrometry.

Eligibility: Inclusion Criteria:
  -  Patients with adenocarcinoma of breast, colon, rectum, ovary , stomach, pancreas
  Exclusion Criteria:
  -  Withdrawal of consent
  -  Small specimen which does not allow to retrieve tissue without interfering with pathologic evaluation

Relevance to patient case: not relevant
Patient case: 48-year-old male with Pancreatic cancer. Genetic variant: CDK6 Amplification. Other conditions: None.

Clinical trial: Study of Gemcitabine and Oxaliplatin With Radiation Therapy in Patients With Pancreatic Cancer

Summary: This study will examine a sequence of treatments including pre-operative chemotherapy and radiation, surgery and post-operative chemotherapy for resectable pancreatic cancer.

Detailed description: This study will examine a sequence of treatments including pre-operative chemotherapy and radiation, surgery and post-operative chemotherapy for resectable pancreatic cancer. This research treatment will evaluate the combination of two chemotherapy agents, oxaliplatin and gemcitabine with radiation therapy. The researchers have already done studies using oxaliplatin, gemcitabine and radiation therapy together for pancreatic cancer. They want to build on the information they have from this previous research and do the research at multiple sites. They will use this study to determine how well people do who are treated with gemcitabine, oxaliplatin, and radiation therapy prior to having surgery for their pancreatic cancer. The researchers will also gather more information about what type of side effects occur with this treatment.

Eligibility: Inclusion Criteria:
  -  Patients must have cytologic or histologic confirmation of carcinoma arising in the pancreas.
  -  Patients must be deemed resectable or borderline resectable based on criteria in section 4.2 prior to registration.
  -  Patients must have an expected life expectancy of at least 12 weeks and a Zubrod performance status of < 2.
  -  Patients must have adequate organ function defined as follows: absolute neutrophil count of > 1500/mm3, platelets > 100,000/mm3, serum Cr < 1.5 mg/dl, total bilirubin < 3.0 mg/dl with relief of biliary obstruction if present (PTC tube or endobiliary stent).
  -  Patients must be free of other active systemic malignancy, ongoing infection, including HIV infection, or any other serious uncontrolled, concomitant systemic disorders or psychiatric condition that would interfere with the safe delivery of protocol therapy.
  -  Patients must be aware of the investigational nature of the therapy and provide written informed consent.
  -  Patients must have no history of previous chemotherapy for pancreatic cancer or any abdominal radiation therapy.
  -  Patients must not have used any investigational agent in the month before enrollment into the study.
  Exclusion Criteria:
  -  Patients with neuroendocrine tumors are excluded.
  -  Patients with preexisting peripheral neuropathy > grade 2 are ineligible.
  -  Pregnant or nursing women are ineligible and patients of reproductive potential must agree to use an effective contraceptive method during participation in this trial and for 6 months after trial.

Relevance to patient case: not relevant
Patient case: 48-year-old male with Pancreatic cancer. Genetic variant: CDK6 Amplification. Other conditions: None.

Clinical trial: Making Decisions About Participating in a Cancer Clinical Trial for Patients With Stage II, Stage III, or Stage IV Pancreatic Cancer or Stage III or Stage IV Colon Cancer or Rectal Cancer

Summary: RATIONALE: Determining how patients makes decisions about participating in a clinical trial may help doctors plan clinical trials in which more patients are willing to participate and are satisfied with their decision to participate.
  PURPOSE: This clinical trial is studying how patients with stage II, stage III, or stage IV pancreatic cancer or stage III or stage IV colon cancer or rectal cancer make decisions about participating in a clinical trial.

Detailed description: OBJECTIVES:
  -  Determine the relationship between disease factors, patient factors, and understanding of the cancer clinical trial, and preferences for decision control in the decision to participate in a cancer clinical trial by patients with stage II-IV pancreatic cancer or stage III-IV colon or rectal cancer.
  -  Determine the relationship between disease factors, patient factors, understanding of the cancer clinical trial, and preferences for decision control with satisfaction with the decision to participate in a cancer clinical trial.
  -  Determine how quality of life, trust, and hope impact the decision to participate in a cancer clinical trial and the satisfaction with this decision.
  OUTLINE: This is a cross-sectional study.
  Patients complete 12 questionnaires to assess their symptom burden (e.g., nausea, pain, fatigue), sociodemographics, hope, quality of life, trust in the healthcare system, trust in health professionals, research decision control, perceived risks, adequacy of research information, clinical trial participation, and decision satisfaction.
  PROJECTED ACCRUAL: A total of 200 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of 1 of the following:
  -  Stage II-IV pancreatic cancer
  -  Stage III-IV colon cancer
  -  Stage III-IV rectal cancer
  -  Offered the opportunity to participate in a phase I-III cancer clinical trial and agreed or declined to participate
  -  First appointment at the Sidney Kimmel Comprehensive Cancer Center at John Hopkins
  PATIENT CHARACTERISTICS:
  -  Able to read English
  PRIOR CONCURRENT THERAPY:
  -  Not specified

Relevance to patient case: not relevant
Patient case: 48-year-old male with Pancreatic cancer. Genetic variant: CDK6 Amplification. 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: 48-year-old male with Pancreatic cancer. Genetic variant: CDK6 Amplification. Other conditions: None.

Clinical trial: Study Assessing the Effect of Transpapillary Pancreas Duct Stent in Resection of the Pancreatic Tail

Summary: Randomized study assessing the effect of transpapillary pancreas duct stent in resection of the pancreatic tail.

Detailed description: Resection of the pancreatic tail is fraught with fistula or leakage of pancreatic enzymes to varying degrees between 13-64%, depending upon which definition one uses. The "downstream" control of the pancreatic duct with the help of a transpapillary stent might minimize the risk for leakage over the transected pancreas surface.
  Trial evaluation will be A. The pancreatic bed was drained and postoperatively the fluid was continuously collected and daily analysed for pancreatic amylase and bilirubin. Daily measurement of pancreatic enzyme content in the drain fluid, at least for 5 post operative days or as long as the patient retains the drain. X-Amylase and X-Protein as long as the patient has the external drain.
  B. Co-variables measured in the form of: operation time, complications in relation to diagnosis, duration of hospitalization. Patients receiving a pancreas stent are followed in order to evaluate the natural course of the pancreas stent.

Eligibility: Inclusion Criteria:
  -  Inclusion Criteria include all patients planned to undergo resection of the pancreatic body-tail are invited to participate.
  Exclusion Criteria:
  -  The Patients who, at the time of exploration, judged to have a tumour, which is un-resectable.

Relevance to patient case: not relevant
Patient case: 48-year-old male with Pancreatic cancer. Genetic variant: CDK6 Amplification. Other conditions: None.

Clinical trial: GEM vs GEM+TS-1 for Advanced Pancreatic Cancer

Summary: The primary objective of this study is to compare tumor response rate of the test arm(gemcitabine+S-1) with the control arm(gemcitabine alone) in patients with unresectable pancreatic cancer

Detailed description: Pancreatic cancer is the fifth leading cause of cancer death in the United States. It is difficult to diagnose at its early stage and only 10-20% of patients are candidates for resection with 5-year survival rate of less than 10%. Patients with unresectable pancreatic cancer has a poor prognosis. Gemcitabine, a cytidine analogue, is the standard chemotherapeutic agent for the disease with median survival time(MST) ranging from 6 to 8 months. Phase Ⅲ study showed that combinations with other drugs, such as oxaliplatine or CDDP, did not contribute to survival time. TS-1, a new oral fluoropyrimidine which consists of the 5-FU prodrug tegafur (ftorafur, FT) and two enzyme inhibitors, CDHP (5-chloro-2,4-dihydroxypyridine) and OXO (potassium oxonate), in a molar ratio of 1(FT):0.4 (CDHP):1(OXO), is commercially available since late 90'in Japan. Phase II trials have demonstrated that S-1 was effective as a single agent for treatment of gastric (RR 44.6%), colorectal (RR 37.4%), head and neck, breast, non-small cell lung, and pancreatic cancers(20%). A combination of gemcitabine and TS-1 is found to be effective and promising in phase Ⅱ trial for metastatic pancreatic carcinoma in selected subjects, but the combination therapy has high rate of side effects. This phase Ⅱ randomized controlled study compares efficacy and feasibility of GEM+S-1 with GEM alone in patients with locally advanced and metastatic pancreatic cancer and performance status of 0-2, aiming at patients in rather ordinary clinical settings.

Eligibility: Inclusion Criteria:
  1. Histologically or cytologically proven unresectable pancreatic carcinoma
  2. There must be measurable lesions with multislice CT
  3. ECOG Performance status 0-2
  4. No other active cancer
  5. No previous therapy such as radiotherapy, chemotherapy and immunotherapy
  6. Adequate organ functions are preserved as WBC more than 4000/mm3,Hb more than 8.0g/dl,neutrophil more than 2000/mm3,platlet more than 100,000/mm3, AST less than 2.5 x normal or less than 5.0 x normal if the patient had known liver metastasis, bilirubin less than 2.0mg/dl, Ccr more than 60ml/min
  7. No serious complications
  8. Be able to eat food
  9. Life expectancy of more than 8 weeks duration
  10. Informed consent is obtained-
  Exclusion Criteria:
  1. Interstitial pneumonia
  2. Uncontrollable diabetes, liver dysfunction, angina pectoris,or myocardial infarction with its onset within 3 months
  3. Serious infection
  4. Pregnant or lactating females
  5. History of serious drug allergy
  6. Serious other complications
  7. Uncontrolled mental disorders -

Relevance to patient case: not relevant
Patient case: 48-year-old male with Pancreatic cancer. Genetic variant: CDK6 Amplification. Other conditions: None.

Clinical trial: Open-label Study of CS1008 for Subjects With Untreated and Unresectable Pancreatic Cancer

Summary: Phase 2 study to determine the efficacy and safety of CS-1008 when given with gemcitabine to subjects with previously untreated and unresectable (unable to be surgically removed) or metastatic (spread to other areas beyond the pancreas) pancreatic cancer.

Detailed description: Primary Objective:
  - To evaluate the efficacy of CS-1008 administered in combination with gemcitabine to chemotherapy naive subjects with unresectable or metastatic pancreatic cancer, based on the progression-free survival rate at 16 weeks.
  Secondary Objectives:
  -  To evaluate the efficacy of CS-1008 administered in combination with gemcitabine on overall progression-free survival rate, objective response rate, duration of response and overall survival.
  -  To determine the pharmacokinetics of C-1008 and gemcitabine
  -  To study potential biomarkers of CS-1008 activity
  -  To evaluate the safety profile of CS-1008 when administered in combination with gemcitabine to chemotherapy naive subjects with unresectable or metastatic pancreatic cancer.

Eligibility: Inclusion Criteria:
  -  Histologically or cytologically confirmed resectable or metastatic pancreatic cancer; not previously treated with chemotherapy; measurable disease; 18 years of age or older
  Exclusion Criteria:
  -  No anticipated need for major surgery or radiation therapy during the study
  -  Heart Disease exclusions:myocardial infarction or unstable angina within the past 6 months; severe or unstable angina pectoris within the past 6 months; coronary or peripheral artery bypass graft within the past 6 mo., etc.
  -  No clinically significant active infection or history of HIV
  -  No partial or complete bowel obstruction
  -  Cannot have poorly controlled psychiatric illness

Relevance to patient case: not relevant
Patient case: 48-year-old male with Pancreatic cancer. Genetic variant: CDK6 Amplification. Other conditions: None.

Clinical trial: A Phase 1 Study Testing CP-675,206 In Combination With Gemcitabine In Patients With Previously Untreated, Advanced Pancreatic Cancer

Summary: The purpose of this study is to determine the safety and tolerability of different doses of CP-675,206 in combination with gemcitabine and to determine the maximum dose of CP-675,206 that is well tolerated when given in combination with gemcitabine to patients with advanced pancreatic cancer.


Eligibility: Inclusion Criteria:
  -  Patients with metastatic pancreatic cancer
  -  Patient must have adequate bone marrow, liver and kidney function
  -  Patient must have an Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1
  -  Chemotherapy naive
  -  Inoperable pancreatic cancer
  Exclusion Criteria:
  -  Patient must not have received prior systemic therapy for pancreatic cancer
  -  Patient must not have previously received anti-CTLA4 therapy
  -  History of chronic inflammatory or autoimmune disease

Relevance to patient case: not relevant
Patient case: 48-year-old male with Pancreatic cancer. Genetic variant: CDK6 Amplification. Other conditions: None.

Clinical trial: EUS-CPN: A Retrospective Review

Summary: The purpose of this retrospective study is to measure the safety of EUS-CPN in patients that have undergone this procedure in the last decade.


Eligibility: Inclusion Criteria:
  -  Any subject that has undergone EUS-CPN will be considered for this study.
  Exclusion Criteria:
  -  Subjects will be excluded if they have undergone a celiac plexus neurolysis (endoscopic, percutaneous, or surgical) at an another institution.

Relevance to patient case: not relevant