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

Clinical trial: Role of Cyberknife Stereotactic Radiation Therapy (SBRT) Followed by Gemcitabine for Patients With Locally Advanced Pancreatic Cancer

Summary: The purpose of this study is to evaluate the efficacy and safety of stereotactic radiation therapy given in five fractions (30 Gray in 5 fractions) followed by gemcitabine in patients with locally advanced pancreatic cancer.

Detailed description: The purpose of this phase I/II study is to evaluate the efficacy and toxicity of a different stereotactic body radiation therapy regimen combined with gemcitabine. In the present study, 5 daily fractions of 6 Gray will be given over two weeks. Stereotactic body radiation therapy will be given with the Cyberknife system. This treatment technique allows to give a higher dose to the tumor as compared to conventional external beam radiation while lowering the dose to the normal tissues around. This treatment system is also capable of following the motion that the pancreas assumes during respiration as well as during treatment. This enables us to reduce the margin of security and further reduce dose to surrounding normal tissue.
  The primary objective of this study is to evaluate acute and chronic toxicity of this regimen of stereotactic radiation therapy followed by gemcitabine. Quality of life, local control and overall survival will also be evaluated.

Eligibility: Inclusion Criteria:
  -  Pancreatic Adenocarcinoma, histologically and/or cytologically proven
  -  Locally advanced pancreatic cancer, surgically non resectable
  -  No distant metastasis
  -  Work-up including medical history, physical exam, biochemistry, chest X-ray, CT-scan of abdomen and pelvis
  -  ECOG performance status : ≤ 2
  -  Primary tumor visible on CT-scan
  -  Maximum tumor diameter of 6 cm (including primary tumor and regional lymph nodes)
  -  White blood cell count > 3000 /uL, Neutrophils > 1500 /uL, Platelets > 100 000/uL, Hemoglobin > 95 mg/L, Total bilirubin < 1,5 normal limit, AST/ALT < 2,5 normal limit, normal creatinin
  -  ≥ 18 years of age
  -  Signed informed consent
  Exclusion Criteria:
  -  Prior abdominal radiation therapy
  -  Connective tissue disease (scleroderma, lupus)
  -  Prior treatment for pancreatic cancer such as radiation therapy, chemotherapy or surgery.

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

Clinical trial: L-CARnitine in the Palliative Treatment of Advanced PANcreatic Cancer (CARPAN)

Summary: The study investigated the role of L-Carnitine supplementation on proinflammatory immune response, malnutrition, cancer cachexia and cancer related fatigue in advanced and inoperable pancreatic cancer, UICC Stage IV .

Detailed description: Pancreatic cancer has the lowest 5-year survival rate of any cancer and ranks as the fourth leading cause of cancer death world wide. Several metabolic changes are present in the whole body in case of cancer so the investigators conducted a placebo controlled, double blinded, randomized, prospective and multicentre study to investigate, whether L-Carnitine supplementation may have an impact on malnutrition, cancer cachexia and cancer related fatigue in advanced pancreatic cancer.
  Study drug: L-Carnitine 4g per day (vers) Placebo Study design: A multi-centre, double blind, and placebo-controlled, randomised, parallel group study
  Patient population: Patients with advanced pancreatic carcinoma Number of patients: Total of 90 patients in two equal groups number of centres: 4 (Greifswald, Magdeburg, Berlin,Heidelberg,all Germany) Duration of dosing: 12 weeks

Eligibility: Inclusion Criteria:
  -  advanced pancreatic cancer (UICC Stage IV)
  -  Karnofsky Index larger than 60
  -  compliance
  -  consent to participate to the study
  Exclusion Criteria:
  -  Child-Pugh classification of liver failure greater than Child B,
  -  a known second malignant tumor
  -  oral or parenteral supplementation with omega-3-fatty acids
  -  treatment with thalidomide or Infliximab
  -  mental or physical 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: Stereotactic Body Radiotherapy for Unresectable Pancreatic Cancer

Summary: This study will evaluate the local control rate as well as acute and late toxicity rates of stereotactic body radiotherapy (SBRT) for the treatment of unresectable pancreatic cancer.

Detailed description: This is a single institution, non-randomized, prospective, phase IV trial of SBRT for unresectable pancreatic cancer.
  Data collected will include patient demographics, pathology data, tumor stage, SBRT dose fractionation scheme, dose received by adjacent critical normal tissues, tumor recurrence data, and acute and late toxicities.
  Follow up data will be collected during the patient's standard office visits. The anticipated duration of this study is 5 years.

Eligibility: Inclusion Criteria:
  -  Patient age >= 18 years
  -  Performance status of 0-3
  -  Unresectable pancreatic cancer
  -  Maximum tumor diameter < 7.5 cm
  -  Signed study-specific consent form
  Exclusion Criteria:
  -  Maximum tumor diameter > 7.5 cm
  -  Prior radiotherapy to the upper abdomen
  -  Pregnant or lactating women, due to potential exposure of the fetus to RT and unknown effects of RT on lactating females
  -  Patients with psychiatric or addictive disorder that would preclude obtaining informed consent

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

Clinical trial: 22G FNA Needle vs. 22G ProCore Needle

Summary: The aim of this research study is to identify the best needle for performing biopsy during EUS procedures. There are two types of needles for performing biopsy: A FNA needle that provides a small sample of tissue for analysis and a ProCore needle that provides larger amount of tissue. It is not clear at this point which of the two needles is superior for performing biopsy. This study will attempt to identify the better needle by assessing the performance of both needles in a randomized fashion.

Detailed description: In this randomized trial, the 22G fine needle aspiration needle was compared with the newly developed 22G ProCore needle for sampling pancreatic mass lesions during endoscopic ultrasound. Patients were randomized into the two needle groups and then various outcomes were compared between the two needle types, including the number of passes needed to establish a diagnosis, the ability to procure enough tissue sample to be able to make a diagnosis, the rates of needle failure and complication rates.

Eligibility: Inclusion Criteria:
  -All patients with solid pancreatic mass lesions
  Exclusion Criteria:
  -  Coaguloapthy,
  -  minors,
  -  prgenant patients

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

Clinical trial: Fixed Dose Rate Gemcitabine and Cisplatin Followed by Chemoradiation for Locally Advanced Pancreatic Cancer

Summary: This is a phase Ⅱ trial of fixed dose rate gemcitabine and cisplatin chemotherapy followed by chemoradiation with capecitabine in patients with locally advanced pancreatic cancer.

Detailed description: The main purpose of this study is to evaluate the efficacy and safety of fixed dose rate gemcitabine and cisplatin chemotherapy followed by chemoradiation with capecitabine in patients with locally advanced pancreatic cancer.

Eligibility: Inclusion Criteria:
  -  unresectable locally advanced pancreatic cancer
  -  no distant metastasis
  -  histologically confirmed adenocarcinoma of pancreas
  -  18-75 of age
  -  ECOG performance status 0-2
  -  normal marrow function :
  -  WBC at least 3,000/mm3 OR Absolute neutrophil count at least 1,500/mm3
  -  Platelet count at least 100,000/mm3
  -  normal liver function :
  --Bilirubin no greater than 2.0 mg/dL AST less than 3 times upper limit of normal (ULN)
  -  normal renal function :
  --Creatinine no greater than 1.5 times ULN
  -  signed informed consent

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

Clinical trial: Adjuvant Gemcitabine and Cisplatin Followed by Chemoradiation for Resected Pancreatic Cancer

Summary: This is a phase Ⅱ Trial of Postoperative Adjuvant Gemcitabine and Cisplatin Chemotherapy Followed by Chemoradiation With Gemcitabine in Patients With Resected Pancreatic Cancer.

Detailed description: The primary study objective is to evaluate recurrence/metastasis free survival at 12 months with postoperative adjuvant treatment incorporating gemcitabine plus cisplatin chemotherapy followed by chemoradiation with gemcitabine followed by maintenance chemotherapy with gemcitabine.

Eligibility: Inclusion Criteria:
  1. Give written informed consent prior to study specific screening procedures, with the understanding that the patient has the right to withdraw from the study at any time, without prejudice.
  2. Be between 18 and 75 years of age.
  3. Patients who are ambulatory and have a ECOG Performance Status of 0-2.
  4. Histologically confirmed pancreatic adenocarcinoma.
  5. Received curative resection (R0 resection) of stage 1b ~ 2b pancreatic cancer (according to AJCC staging, 6th edition - Appendix 1), no more than 8 weeks has elapsed since the time of operation.
  6. WBC at least 3,000/mm3 OR Absolute neutrophil count at least 1,500/mm3. Platelet count at least 100,000/mm3.
  7. Bilirubin less than 2.0 mg/dL, AST less than 3 times upper limit of normal (ULN).
  Serum creatinine no greater than 1.5 times ULN.
  Exclusion Criteria:
  1. Pregnant or lactating woman.
  2. Woman of childbearing potential with either a positive or no pregnancy test at baseline.
  3. Woman of childbearing potential not using a reliable and appropriate contraceptive method (postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential).
  4. Sexually active males unwilling to practice contraception during the study.
  5. Prior chemotherapy for the treatment of pancreatic carcinoma.
  6. Radiotherapy incorporating radiation fields of more than 25% of active bone marrow.
  7. History of another malignancy within the last five years except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix.
  8. Clinically significant cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease, and cardiac arrhythmias not well controlled with medication).
  9. Participation in any investigational drug study within four weeks preceding the start of study treatment.
  10. Serious, uncontrolled, intercurrent infection(s).
  11. Other significant medical conditions that would, in the judgment of the investigator, make administration of study drug unsafe.

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

Clinical trial: Chemotherapy for Patients With Locally Advanced Pancreatic Cancer (LAPC) With Additional Chemo-radiotherapy (CRT) for Patients With Borderline Resectable Tumours

Summary: Treating patients with initial local non-resectable pancreatic cancer with a combination of oxaliplatin, irinotecan & 5-FU(FOLFIRINOX), consolidated with chemoradiotherapy in potentially resectable patients, will result in a high rate of tumor shrinkage allowing subsequent resection in patients with initial borderline resectable tumors and improved overall survival for all patients.

Detailed description: Pancreatic cancer (PC) is the third most common gastrointestinal malignancy and one of the top ten leading causes of cancer deaths in the Western world. Patients with PC can be divided into three subgroups; resectable (rPC), locally advanced (LAPC) and metastatic (mPC). For patients with rPC surgery offers the best chance for long term survival. However it is estimated that only 20% of patients have rPC at the time of diagnosis. For patients with LACP, invasion of local large vessels is most often the cause for non-resectability. The median survival of these patients is between 6 to 12 months and long term survival in is extremely rare. The optimal treatment of LAPC is controversial. Treatment strategies vary between attempts to "downstage" the tumour to rPC, or treat the patients in a palliative setting only. Phase II studies and retrospective series have evaluated various treatments regimens and strategies including chemotherapy and radiotherapy (RT) alone or in combination - chemoradiotherapy (CRT). Results from these trials give no clear answer regarding the best treatment strategy. However, data from several studies shows that treatment of LAPC may result in shrinkage of the tumour, and thus potentially lead to a resection; also data suggests that CRT after chemotherapy improves treatment efficacy. Recent data from patients with mPC has show a combination of oxaliplatin, irinotecan and 5-FU (FOLFIRINOX) increases response rates from 10% to 30% and median survival to 11.1 months. The promising efficacy makes it natural to attempt this treatment in patients with LAPC.

Eligibility: Inclusion Criteria: (major)
  -  non-metastatic pancreatic cancer
  -  Performance status 0-1
  -  Bilirubin < 1.5 UNL
  -  Written informed consent
  Exclusion Criteria: (major)
  -  no prior abdominal radiotherapy
  -  no prior chemotherapy for pancratic cancer
  -  no severe comorbidity
  -  patients must be able to undergo potential abdominal surgery

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

Clinical trial: Pancreatic Enzyme Suppletion in Pancreatic Cancer

Summary: This study will evaluate the effect of immediate pancreatic enzyme suppletion on the physical and mental health status and survival of patients who are diagnosed with pancreatic cancer and are highly likely to develop exocrine pancreatic insufficiency during their disease process.

Detailed description: Weight loss in cancer is caused by primary tumour effects and secondary effects (e.g. side effects of treatment, mechanical and intestinal obstruction). In pancreatic cancer, additional weight loss and malnutrition may be due to the development of exocrine pancreatic insufficiency (EPI). The presence of EPI in pancreatic cancer is frequently overlooked, because the focus of treatment is directed at possible surgery or chemotherapy and its potential side effects. Although studies have proven that pancreatic enzymes may prevent or decrease weight loss, they are seldom being prescribed.

Eligibility: Inclusion Criteria:
  -  Adenocarcinoma of the pancreas (histologically confirmed)
  -  Normal exocrine pancreatic function (Fecal Elastase test > 0.2 mg/g)
  -  Capable and willing to follow instructions given by the physician.
  Exclusion Criteria:
  -  Other causes of fat malabsorption (celiac disease, IBD, and major gastrointestinal surgery).
  -  < 18 years.

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

Clinical trial: The Study of Metastatic Pancreatic Adenocarcinoma

Summary: Phase I part, Primary objective: the maximum tolerated dose of S-1 in the SLOG regimen Secondary objectives: the dose-limiting toxicity of the regimen Phase II part, Primary objective: Overall tumor response rate (by RECIST criteria) Secondary objectives: Disease control rate (Objective response rate (ORR) + stable disease ≧ 16 weeks), Time to tumor progression, Progression-free survival, Overall survival ,Safety profile, Biomarker study

Detailed description: Phase I: 2~24 patients Phase II: Considering a design with p0 = 0.25 and p1 = 0.40 for which error is 0.10 and errors is 0.20, these constraints can be met with a two-stage Simon's design of 25 patients in the first stage and 27 patients in the second stage.

Eligibility: Inclusion criteria:
  1. Patients must have cyto-/histologically confirmed, recurrent or metastatic adenocarcinoma of the pancreas (mPAC).
  2. Patients must have no history of prior chemotherapy.
  3. Patients with prior radiotherapy.
  4. Patients' baseline ECOG performance status must be 2.
  5. Patients' life expectancy must be 12 weeks or greater.
  6. Patients' age must be 20 and 75.
  7. Patients must have adequate bone marrow function.
  8. Patients must have adequate liver and renal function.
  9. All patients must be sign and give written informed consent.
  Exclusion criteria:
  1. Patients who have major abdominal surgery, radiotherapy.
  2. Patients with central nervous system metastasis.
  3. Patients with active infection.
  4. Pregnant or breast-nursing women.
  5. Patients with active cardiopulmonary disease.
  6. Patients who have peripheral neuropathy > Grade I.
  7. Patients who have serious concomitant systemic disorders.
  8. Patients who have other prior or concurrent malignancy.
  9. Patients who are under biologic treatment for their malignancy.

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

Clinical trial: Tissue Procurement for Gastric Cancer, Gastrointestinal Stromal Tumors (GIST), Esophageal Cancer, Pancreas Cancer, Hepatocellular Cancer, Biliary Cancer, Neuroendocrine, Peritoneal Mesothelioma, Anal Cancer and Colorectal Cancer in Patients Undergoing Surgery or Biopsy

Summary: The purpose of this study is to collect and store normal and malignant tissue from patients with gastric cancer, GIST, esophageal cancer, pancreas cancer, hepatocellular cancer, biliary cancer, neuroendocrine, peritoneal mesothelioma, anal cancer and colorectal cancer, an estimated 50 to 100 of each tumor type. To collect and store blood samples from patients with gastric cancer, GIST, esophageal cancer, pancreas cancer, hepatocellular cancer, biliary cancer, neuroendocrine, peritoneal mesothelioma, anal cancer and colorectal cancer. To create a database for the collected tissue and allow access to relevant clinical information for current and future protocols. To create tissue microarrays for each gastrointestinal cancer subtype, namely, gastric cancer, GIST, esophageal cancer, pancreas cancer, hepatocellular cancer, biliary cancer, neuroendocrine, peritoneal mesothelioma, anal cancer and colorectal cancer, to facilitate future molecular studies. To grant access to Dr Kindler, Dr. Salgia, and Dr. Catenacci to this database (as it is being acquired) of the coupled patient tissue samples (normal and malignant) and relevant clinical information for the investigation of tyrosine kinases, such as Met and Ron, receptor tyrosine kinase family members, STATs, paxillin, focal adhesion proteins, cell motility/migration proteins, tyrosine/serine/threonine kinase family members, related molecules, and downstream targets implicated in the pathogenesis of GI cancers. Examples of molecular testing include evaluation of DNA mutation, alternative splice variants, protein expression and phosphorylation, and immunohistochemistry on samples. These studies will be correlated with clinical information as stated above.


Eligibility: Inclusion Criteria:
  -  any patient diagnosed with Gastric (stomach) Cancer, Esophageal (foodpipe) Cancer, Pancreas Cancer, Liver Cancer, Biliary (gallbladder) Cancer, Gastrointestinal Stromal Tumor, Peritoneal Mesothelioma (cancer in the lining of the abdomen), Neuroendocrine (of or relating to the cells that release a hormone into the blood in response to a neural stimulus) Tumor, Anal Cancer or Colorectal Cancer cancer that requires you to undergo a surgical or diagnostic procedure.

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 to Evaluate if Neoadjuvant Radiotherapy Improves Recurrence Free Survival in Pancreatic Head Cancer

Summary: Net-Pac investigates if radiation prior to surgical resection improves survival in patients with pancreatic head cancer without metastases.

Detailed description: The trial is designed to show that neoadjuvant radiotherapy followed by surgery improves local recurrence free survival compared to surgery alone in patients with resectable adenocarcinoma of the pancreatic head.

Eligibility: Inclusion Criteria:
  -  Histologically confirmed adenocarcinoma of the pancreatic head
  -  Age ≥ 18 years
  -  Signed informed consent
  -  ECOG performance status of 0-2
  Exclusion Criteria:
  -  Curative resection is not feasible or presence of metastatic disease
  -  Patients not eligible for surgery (ASA ≥ 4)
  -  Participation in an other clinical trial
  -  Unable or unwilling to sign the informed consent

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

Clinical trial: Special Investigation (All Cases) of LipaCreon in Patients With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis

Summary: This study aims at collecting the information related to the safety and effectiveness in the pancreatic exocrine insufficiency patients due to cystic fibrosis receiving the treatment with LipaCreon in order to evaluate the effective and safe use of LipaCreon.


Eligibility: Inclusion Criteria
  -  Patients who receive LipaCreon for the replacement of pancreatic digestive enzymes in pancreatic exocrine insufficiency due to cystic fibrosis
  Exclusion Criteria
  -  Patients with a history of hypersensitivity to the ingredient of LipaCreon.
  -  Patients with a history of hypersensitivity to porcine protein

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

Clinical trial: Special Investigation of LipaCreon on Long-term Use in Patients With Pancreatic Exocrine Insufficiency

Summary: This study aims at collecting the information related to the safety and effectiveness in the pancreatic exocrine insufficiency patients receiving the treatment with LipaCreon for a long term in order to evaluate the effective and safe use of LipaCreon.


Eligibility: Inclusion Criteria
  -  Patients who receive LipaCreon for the replacement of pancreatic digestive enzymes in pancreatic exocrine insufficiency
  Exclusion Criteria
  -  Patients with a history of hypersensitivity to the ingredient of LipaCreon.
  -  Patients with a history of hypersensitivity to porcine protein.

Relevance to patient case: not relevant