araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 70-year-old male with Lung cancer. Genetic variant: ERBB2 Amplification. Other conditions: Arthritis.

Clinical trial: Recovery and Rehabilitation After Lung Cancer Surgery

Summary: The specific aims of this translational, interdisciplinary, multi-center, international research study with 300 Lung cancer patients are to:
  Aim 1 Explore how the patients experience the transfer between different locations and between different levels of care at the same location and how they experienced coming home.
  Aim 2 Explore lung cancer patients' symptoms, symptom clusters, and changes in symptoms and symptom clusters over time.
  Aim 3 Explore interaction between lung cancers patients' symptoms, symptom clusters, health related quality of life and social support.

Detailed description: Approximately 2500 patients are diagnosed with lung cancer annually i Norway, and approximately 400 of these undergo surgery. Many patients report that life after lung cancer surgery is difficult. After surgery, the patients are frequently transferred to a local hospital or to another level of care at the hospital where they were operated. The transfer is critical for patients' safety because communication failure is one of the most common causes of medical error.
  Studies that have analyzed the quality of life of lung cancer patients after surgery reach different conclusions about the patients' Quality of life (QOL), some studies state that lung cancer patients are back to normal quality of life after 9 months, while others indicate that the patients still have reduced QOL two years after surgery. It is difficult to assess the reason for the differences in results as most of the studies used the same QOL questionnaire. Studies that have evaluated the social support that lung cancer patients receive indicate that lung cancer patients receive less support than other cancer patients.
  Lung cancer patients have a wide range of physical problems (fatigue, dyspnea, coughing and pain) and psychological (depression) problems following surgery.
  Based on findings from this literature review a need exist for improved postoperative follow-up of patients after surgery for lung cancer The proposed study will evaluate the social support, the levels of lung cancer stigma, symptoms and changes in this over time as well as evaluate patient experience with transfer in the immediate postoperative period.

Eligibility: Inclusion Criteria:
  -  patients with lung cancer patients above the age of 18 that have been treated with surgery, who are able to speak and understand Norwegian,
  Exclusion Criteria:
  -  and who suffer no cognitive impairment.

Relevance to patient case: not relevant
Patient case: 70-year-old male with Lung cancer. Genetic variant: ERBB2 Amplification. Other conditions: Arthritis.

Clinical trial: MILES-3: Cisplatin in Combination With Gemcitabine for Elderly Patients With Lung Cancer

Summary: The purpose of this study is to evaluate the addition of cisplatin to first-line chemotherapy with gemcitabine in elderly patients with non small cell lung cancer in terms of overall survival.


Eligibility: Inclusion Criteria:
  -  Cytological or histological diagnosis of non small-cell lung cancer (NSCLC)
  -  Stage III B or Stage IV disease
  -  Age > or = 70 years
  -  ECOG Performance status 0 or 1
  -  Patient at first diagnosis or with recurrence after primary surgery
  -  At least one target or non-target lesion according to RECIST criteria
  -  Life expectancy of at least 3 months
  -  Neutrophils > 1500/mm3, platelets > 100,000/mm3, hemoglobin > 10g/dl
  -  Creatinine < 1.5 x the upper normal limit
  -  AST and ALT < 2.5 x the upper normal limits (< 5 x the upper normal limit in the presence of hepatic metastasis)
  -  Bilirubin < 1.5 x the upper normal limit
  -  Signed informed consent
  Exclusion Criteria:
  -  Previous chemotherapy for advanced disease
  -  History of malignant neoplasm within the previous 5 years (not including non-melanoma skin carcinoma and in-situ carcinoma of the uterine cervix, provided they are being adequately treated)
  -  Symptomatic cerebral or spinal cord metastasis
  -  Myocardial infarct within the last 12 months
  -  Systemic disease not controlled with treatment (active infection, cardiovascular, hepatic, renal or metabolic) that would not, in the opinion of the investigator, permit the patient to undergo chemotherapy.
  -  Known or suspected hypersensitivity to any of the drugs used in the study
  -  Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or give informed consent

Relevance to patient case: not relevant
Patient case: 70-year-old male with Lung cancer. Genetic variant: ERBB2 Amplification. Other conditions: Arthritis.

Clinical trial: TrasGEX™: Dose Escalation Study

Summary: This is a prospective, open label, multicenter study evaluating the safety, tolerability and pharmacokinetics of TrasGEX™ after intravenous administration in patients with HER-2 positive cancers. The effect of TrasGEX™ on the development of anti-drug antibodies and on tumour response will also be evaluated.


Eligibility: Main Inclusion Criteria:
  1. Signed written informed consent granted prior to initiation of any study-specific procedures;
  2. Male or female patients of ≥18 years of age;
  3. ERBB2 (HER-2) gene amplification or ERBB2 overexpression
  4. Histologically or cytologically confirmed cancer, either locally advanced or metastatic;
  5. No anti-tumor therapy of proven benefit available at study enrollment;
  6. Life expectancy of >=3 months;
  7. Eastern Cooperative Oncology Group (ECOG) performance status (PS) <=2;
  8. Male or female patients of child-producing potential must agree to use contraceptive measures or oral contraception during the study and for 28 days after the last dose of TrasGEX™;
  9. Female patients of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose of TrasGEX™;
  and
  Main Exclusion Criteria:
  1. Anti-cancer chemotherapy, radiotherapy, immunotherapy, or investigational agents within 4 weeks of the first dose of TrasGEX™;
  2. Major surgery within four weeks of the first dose of TrasGEX™;
  3. Newly diagnosed brain metastases, metastases that have been documented to be stable for <3 months, or metastases for which systemic corticosteroids are required;
  4. History of allergic reactions attributed to compounds of similar chemical or biologic composition as TrasGEX™;
  5. History of myocardial infarction within 12 months of the administration of the first dose of TrasGEX™;
  6. History of congestive heart failure defined as Class II to IV per New York Heart Association classification within 12 months of the administration of the first dose of TrasGEX™;
  7. Left ventricular ejection fraction <50%;
  8. Previous malignancy other than the current diagnosis within 5 years of the first dose of TrasGEX™;
  9. Pregnancy or lactation; and
  10. Concurrent uncontrolled significant illness

Relevance to patient case: possibly relevant
Patient case: 70-year-old male with Lung cancer. Genetic variant: ERBB2 Amplification. Other conditions: Arthritis.

Clinical trial: High Throughput Technologies to Drive Breast Cancer Patients to Specific Phase I/II Trials of Targeted Agents

Summary: High sensitivity to targeted agents has been observed in patients whose tumor cells present a genetic/genomic deregulation of the target (Kit mutation, ERBB2 amplification, EGFR mutations) together with addiction to the given target. More recently, activation of "alternative pathways" (Kras mutation, PI3K mutations) have been reported as a common resistance mechanism to single agent tyrosine kinase inhibitors (trastuzumab, cetuximab).
  From these data has emerged the hypothesis that identification of the deregulated pathway through new molecular tools could allow to propose a more tailored targeted regimen.
  Based on these concepts, numbers of phase I/II trials enrich their populations in patients presenting specific molecular alterations.
  High throughput technologies (array CGH, sequencing, gene expression array) identify deregulated genes. In addition, these technologies determine whether such genomic alterations are single (expected efficacy of single agent) or multiple (rationale for combination). In a pilot study that included 135 patients, we recently performed a combination of array CGH and hot spot mutation array in order to drive patients into phase I/II clinical trials. This study led to the conclusions that high throughput technologies i. are feasible (80%) and robust, ii. identify "targetable" genomic alterations in around 40% of samples.
  In the present study, the investigators will perform high throughput technologies to drive 400 metastatic breast cancer patients into specific phase I/II trials.


Eligibility: Inclusion Criteria:
  -  Men and Women with histologically diagnosed breast cancer
  -  Metastatic relapse or stage IV breast cancer at diagnosis
  -  Metastases amenable to biopsy
  -  Age <70 years old
  -  PS 0/1
  -  No restriction regarding the number of previous chemotherapy or endocrine therapies
  Exclusion Criteria:
  -  Age <18
  -  Life expectancy <3 months
  -  Symptomatic or progressing brain metastases
  -  Progressive patients at the time of biopsy
  -  LVEF <50% (MUGA or ultrasonography)
  -  Inadequate bone marrow reserve or organ function as demonstrated by any of the following laboratory values:
  -  Absolute neutrophil count < 1.5 x 109/L
  -  Platelet count < 100 x 109/L
  -  Haemoglobin < 90 g/L
  -  ASAT/ALAT > 2.5 times the upper limit of normal (ULN) if no demonstrable liver metastases or > 5 times ULN in the presence of liver metastases
  -  Total bilirubin > 1.5 times ULN
  -  Creatinine >1.5 times ULN
  -  Corrected calcium > ULN
  -  Phosphate > ULN
  -  Abnormal blood coagulation that contra-indicates biopsy
  -  Patients deprived of liberty or placed under the authority of a tutor

Relevance to patient case: not relevant
Patient case: 70-year-old male with Lung cancer. Genetic variant: ERBB2 Amplification. Other conditions: Arthritis.

Clinical trial: Efficacy and Safety of AZD4547 Versus Paclitaxel in Patients With Advanced Gastric or Gastro-oesophageal Cancer

Summary: The purpose of this study is to assess the efficacy, safety and tolerability of AZD4547 compared with paclitaxel in patients with advanced gastric or lower-oesophageal cancer whose tumours are found to have FGFR2 polysomy or gene amplification.

Detailed description: A Randomised Open-Label Phase IIa Study to Assess the Efficacy and Safety of AZD4547 monotherapy versus paclitaxel in Patients with Advanced Gastric or Gastro-oesophageal Junction Cancer with FGFR2 Polysomy or Gene Amplification (SHINE study). Patients were to be assigned to strata by FGFR2 status of: polysomy, low or high gene amplification.

Eligibility: Inclusion Criteria:
  -  Female or male aged 25 or over
  -  Histological diagnosis of locally advanced or metastatic gastro adenocarcinoma (including adenocarcinoma of the lower third of the oesophagus or the gastro oesophageal junction )
  -  Radiographically confirmed progression after 1 prior chemotherapy or chemoradiotherapy for gastric cancer. Suitable for and expected to benefit from paclitaxel monotherapy.
  -  At least one lesion, not previously irradiated, that has baseline at least 10mm in the longest diameter for non nodal lesions and is assessed by Computerised Tomography (CT) or Magnetic Resonance Imaging (MRI)
  -  Provision of either an archival tumour sample or a fresh tumour sample for confirmation of FGFR2 polysomy/gene amplification
  Exclusion Criteria:
  -  Prior exposure to AZD4547 or history of hypersensitivity other drugs similar in structure or class to AZD4547. Hypersensitivity to paclitaxel or formulated in cremophor EL (polyoxyethylated castor oil)
  -  Prior taxane treatment for gastric cancer with the exception of adjuvant/neo-adjuvant therapy given > 6 months; Major surgery, radiotherapy with wide field of radiation or any cancer treatment within 4 weeks before the first dose of the study treatment
  -  With the exception of alopecia, any unresolved toxicities from prior therapy with a Common Terminology Criteria for AE (CTCAE) grade >1 at the time of starting study treatment.
  -  Blood and Echocardiogram (ECG) readings that are deemed to be abnormal by falling outside of the reference ranges in the protocol inclusion/exclusion section.
  -  Taking other regular medication that are predicted to interact with AZD4547 due to their route of metabolism.

Relevance to patient case: not relevant
Patient case: 70-year-old male with Lung cancer. Genetic variant: ERBB2 Amplification. Other conditions: Arthritis.

Clinical trial: A Study of Pertuzumab in Combination With Trastuzumab and Chemotherapy in Patients With HER2-Positive Advanced Gastric Cancer

Summary: This randomized, multicenter, open-label study will evaluate two different doses of pertuzumab in combination with Herceptin (trastuzumab) and chemotherapy in the first-line treatment of participants with metastatic HER2-positive adenocarcinoma of the stomach or gastroesophageal junction. Participants will be randomized in a 1:1 ratio to two treatment arms. Participants in Arm A will receive a pertuzumab loading dose of 840 mg for Cycle 1 and a dose of 420 mg for Cycles 2-6, and participants in Arm B will receive pertuzumab 840 mg for all six cycles. Participants in both treatment arms will receive trastuzumab, cisplatin, and capecitabine.


Eligibility: Inclusion Criteria:
  -  Adult participants, greater than or equal to (>=) 18 of age
  -  adenocarcinoma of the stomach or gastroesophageal junction with inoperable locally advanced or metastatic disease, not amenable to curative therapy
  -  Measurable disease, according to the Response Evaluation Criteria in Solid Tumors (RECIST), v1.1
  -  HER2-positive tumor
  -  Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  -  Life expectancy of at least 3 months
  Exclusion Criteria:
  -  Previous chemotherapy for advanced or metastatic disease (except (prior adjuvant or neoadjuvant therapy at least 6 months before enrollment in the study)
  -  Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome
  -  Active (significant or uncontrolled) gastrointestinal bleeding
  -  Abnormal laboratory values

Relevance to patient case: not relevant
Patient case: 70-year-old male with Lung cancer. Genetic variant: ERBB2 Amplification. Other conditions: Arthritis.

Clinical trial: Study Of Dacomitinib (PF-00299804) In Advanced NSCLC Patients (Post Chemo Or Select First Line) To Evaluate Prophylactic Intervention On Derm And GI AEs And PRO

Summary: To assess the impact of prophylactic treatment on the incidence of adverse events in advanced NSCLC patients (post chemotherapy) treated with dacomitinib daily as a single agent. To assess the impact of an interrupted dacomitinib dosing schedule in Cycle 1 on the incidence of adverse events in first-line advanced NSCLC patients with an EGFR mutation (HER-1 mutation, HER-2 mutation or HER-2 amplification).


Eligibility: Inclusion Criteria:
  -  Advanced Non-Small Cell Lung Cancer (NSCLC).
  -  For Cohort I and Cohort II, advanced NSCLC patients must have received at least one prior regimen of systemic therapy which includes at least one standard chemotherapy for advanced NSCLC and who have failed (ie, progressed or intolerant due to toxicity which precludes further treatment) standard therapy for advanced or metastatic disease. To be considered intolerant to treatment, a patient must have received at least two cycles to be considered previously treated.
  -  For Cohort III, advanced NSCLC patients must not have received prior systemic treatment for their advanced disease and require a known EGFR (HER-1) mutation, HER-2 mutation or HER-2 amplification. Cohort III patients could have received prior adjuvant chemotherapy for Stage I-III disease or combined modality chemotherapy-radiation for Stage IIIA disease is allowed if treatment completed>12 months prior to enrollment.
  -  All cohorts, patients must have evidence of disease; however, measurable disease is not required to enroll.
  -  Eastern Cooperative Oncology Group (ECOG) Performance status 0-2
  -  Estimated creatinine clearance ≥15 mL/min.
  Exclusion Criteria:
  -  Prior treatment with an EGFR-targeted or HER-targeted agent (all cohorts).
  -  Chemotherapy, radiotherapy, biological or investigational agents within 2 weeks of baseline disease assessments (all cohorts).
  -  Patients with known diffuse interstitial lung disease (all cohorts).
  -  Investigational therapy as only treatment for advanced NSCLC without administration of an approved chemotherapy for advanced NSCLC (for Cohort I and Cohort II)

Relevance to patient case: definitely relevant
Patient case: 70-year-old male with Lung cancer. Genetic variant: ERBB2 Amplification. Other conditions: Arthritis.

Clinical trial: Trial Comparing Capecitabine Plus Oxaliplatin (XELOX) and Capecitabine (X) as First-line Chemotherapy in Elderly Patients With Advanced Gastric Cancer

Summary: The objective of the trial is to compare Overall survival between capecitabine plus oxaliplatin (XELOX) and capecitabine (X) as first-line chemotherapy in elderly patients with advanced gastric cancer.


Eligibility: Inclusion Criteria:
  1. Age ≥ 70
  2. Histologically or cytologically confirmed adenocarcinoma of the gastric
  3. Advanced ,metastatic/recurrence gastric cancer
  4. ECOG performance status of 0 to 2
  5. Life expectancy≥3months
  6. No history of any systemic anti-cancer chemotherapy (prior adjuvant chemoradiation or chemotherapy is allowed if the last date of drug administration is > 6months from the study entry date)
  7. No history of radiation therapy about Target lesion. (Prior radiotherapy is permitted if it was not administered to target lesions selected for this study, unless progression of the selected target lesions within the radiation portal is documented, and provided it has been completed at least 4 weeks before randomization.
  8. Adequate marrow functions (ANC ≥ 1,500/uL, PLT ≥100,000/uL)
  9. Adequate renal functions (Creatinine ≤1.5mg/dL or Ccr ≥ 50ml/min)
  10. Adequate hepatic functions ( bilirubin ≤ 2.0mg/dL, SGOT/SGPT < normal x 3)
  11. provision of a signed written informed consent
  Exclusion Criteria:
  1. History of any medical or psychiatric condition
  2. Active infections
  3. Peripheral neuropathy with symptom(NCI-CTCAE ver. 3.0 >=Grade 1 )
  4. symptomatic brain metastases
  5. Double primary cancer (physician at the discretion of the other cancer cured the purpose of early cancer cases can be registered)
  6. History of other malignancy except:
  Adequately treated non-melanomatous skin cancer or cervical carcinoma in situ
  7. Known hypersensitivity to Fluoropyrimidines/platinum
  8. Clinical significant cardiovascular disease (myocardial infarction, symptomatic coronary artery disease, congestive heart failure, severe arrhythmias)
  9. Required immunosuppressive therapy(transplant patients, severe autoimmune disease)

Relevance to patient case: not relevant
Patient case: 70-year-old male with Lung cancer. Genetic variant: ERBB2 Amplification. Other conditions: Arthritis.

Clinical trial: Mindfulness for Lung Cancer Patients and Partners

Summary: The aim of the current study is to examine the (cost)effectiveness of mindfulness based stress reduction (MBSR) in comparison with treatment as usual for patients with lung cancer and their partners.

Detailed description: Receiving a diagnosis of cancer is a major cause of distress and is usually characterized by anxiety and depression. Compared to patients with other cancer diagnoses, patients with lung cancer report higher levels of distress, which probably can be explained by the poor prognosis. At the time of diagnosis, lung cancer is often locally or systematically advanced and 5-year survival is only 15 percent.
  Mindfulness based stress reduction (MBSR) is a recently developed psychological intervention that appears to be promising in terms of reducing psychological distress in cancer patients. It consists of 8 weekly group sessions in which formal and informal mindfulness practices are practiced. As most of the earlier studies have been conducted in patients with breast cancer, it is important to examine the effectiveness of this approach in patients with other types of cancer, such as lung cancer. Furthermore, a diagnosis of cancer is not only highly distressing for the patient but also for the partner and family.
  In this study, the (cost)effectiveness of MBSR compared with treatment as usual will be investigated in 110 patients with lung cancer and 110 partners.

Eligibility: Inclusion Criteria:
  -  Cytologically or histologically proven non-small cell lung cancer and small cell lung cancer.
  -  Patients can participate after lung cancer diagnosis, from start of treatment or after treatment.
  -  Sufficient understanding of Dutch language.
  Exclusion Criteria:
  -  Former participation in MBSR or MBCT course.
  -  Current psychological treatment by psychologist or psychiatrist.
  -  Cognitive impairments hampering participation in MBSR and completion of questionnaires.
  -  Physical impairments prohibiting participation in MBSR training.

Relevance to patient case: not relevant
Patient case: 70-year-old male with Lung cancer. Genetic variant: ERBB2 Amplification. Other conditions: Arthritis.

Clinical trial: Autologous CIK Cells Infusion for the Treatment of Lung Cancer: a Randomized Controlled Study

Summary: To study the efficacy and safety of autologous CIK cells infusion for the treatment of lung cancer.

Detailed description: A randomized controlled trail on the efficacy and safety of autologous cytokine-induced killer (CIK) cells infusion treatment in advanced primary lung cancer

Eligibility: Inclusion Criteria:
  -  18~70 year old, KPS score >50 points, estimate survival > 3 months;
  -  Primary lung cancer patients after chemotherapy or radiation therapy;
  -  Primary lung cancer patients after targeted therapy;
  -  Primary lung cancer patients with lung function can not accept operation or unwilling to operation;
  -  Primary lung cancer recurrence or surgery can't complete resection;
  -  Primary lung cancer patients after intervention therapy(I125 implanted, freezing, rf, etc.);
  -  No serious mental illness and no serious heart, liver, kidney diseases, unincorporated other potentially lethal diseases;
  -  Patients Voluntary attempt, and informed consent.
  Exclusion Criteria:
  -  History of cardiovascular disease: congestive heart failure > New York heart association (NYHA) level II, unstable angina patients (resting when the angina symptoms) or new happen angina pectoris (recent 3 months) or recent 6 months of myocardial infarction;
  -  Cachexia; or other deadly diseases;
  -  Liver function laboratory ALT, AST more than normal limits on 2.0 times ; Or kidney TBIL, BUN more than normal limits on 1.0 times , or Cr more than normal upper limit;
  -  Active infection;
  -  Pregnant or lactating women
  -  At present Is receiving other cancer treatment (such as chemotherapy, radiation therapy, chemotherapy, immunosuppressants and thrombosis, targeted agents);
  -  Now or recently will join another experimental clinical study ;
  -  Other situations that the researchers considered unsuitable for this study (such as mental illness, drug abuse, HIV infections, etc.), or influence on the results of clinical trials for analysis.

Relevance to patient case: not relevant