araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 68-year-old male with non-small cell carcinoma; genetic feature: MET

Clinical trial: Methylation Status of CD44 Promoter Region in Primary Lung Cancer

Summary: This project is to study the methylation status of the transcriptional regulatory region of CD44 gene in surgically resected NSCLC specimens and normal lung tissue, correlate the methylation status of promoter region with the expression of CD44 gene, and analyze if methylation is associated with survival.

Detailed description: CD44 is a cell surface receptor for the extracellular matrix hyaluronan. It mediates adhesion of cells to the extracellular matrix. Its ability to organize extracellular matrix into a medium is also used by cancer cells in their becoming metastatic. Invasive tumor cells are frequently observed to bind hyaluronate.
  CD44 gene is made up of 20 exons, at least 10 of which are variably expressed due to alternative splicing of the mRNA. The standard form, CD44s, has a coding sequence of exons 1-5 and 16-20. Variant isoforms (CD44v), all larger, arise from alternative splicing of combinations of exons 6-15 (v1-10). A variant isoform CD44 can induce metastasis of a rat pancreatic carcinoma. Studies in human tumors, however, have produced variable results. Some breast cancers demonstrate positive correlation between CD44v expression and tumor progression, while others lack any correlation. Some colorectal tumors even show an inverse correlation. CD44 has also been demonstrated to be a metastasis suppressor gene for prostate cancer. Thus, CD44 may be a marker for metastasis for some tumors, but not for others, and it may actually be a metastasis suppressor gene for yet another groups of tumors.
  For primary lung cancer, the correlation between CD44 expression and tumor metastasis has not been established. The metastasis-prone small cell lung cancer rarely showed any immunohistochemical staining for CD44s or CD44v. For non-small cell lung cancer (NSCLC), some studies showed positive correlation between immunohistochemical CD44v expression and tumor progression, while others showed no correlation. Our own study using RT-PCR, sequencing and immunohistochemical staining showed that in pulmonary adenocarcinoma, CD44v6 expression is down-regulated as the disease progressed. Based on our finding, and the observation that CD44s and CD44v expression are low in metastasis-prone small cell lung cancer, we assue that CD44 is a metastasis suppressor gene which is inactivated in lung cancers. Because in prostate cancer DNA hypermethylation has been shown to be related to the down-regulation of CD44 gene, we plan to study the methylation status of the transcriptional regulatory region of CD44 gene in primary lung cancer. We’ll study CD44 expression by immunohistochemistry, the methylation status of CD44 regulatory region by sequencing of the bisulfite-modified genomic DNA, and correlate these two findings with each other, and with histologic type, tumor staging and survival.

Eligibility: Inclusion Criteria:
  -  Non-small cell lung cancer
  Exclusion Criteria:

Relevance to patient case: not relevant
Patient case: 68-year-old male with non-small cell carcinoma; genetic feature: MET

Clinical trial: Validation of Coregistered CT-PET Imaging in Determining Tumor Volume and Atelectasis in Patients With Operable Non-Small-Cell Lung Cancer and Tumor Associated Atelectasis

Summary: CT-PET image fusion has the potential to differentiate 'tumor' from 'atelectasis' much better than the CT-scan in patients with non-small cell lung cancer who also have atelectasis.
  This however has never been validated on a histological level. In this study patients with non small cell lung cancer and atelectasis who are eligible for surgery undergo a CT-scan and a PET-scan prior to surgery.
  The resection specimen will be compared to the preoperative imaging.


Eligibility: Inclusion Criteria:
  -Patients with non small cell lung cancer and atelectasis, who are eligible for surgery.
  Exclusion Criteria:
  -  age < 18 years
  -  pregnancy

Relevance to patient case: not relevant
Patient case: 68-year-old male with non-small cell carcinoma; genetic feature: MET

Clinical trial: Intensity Modulated Radiation Therapy for Head and Neck Cancer

Summary: Many normal tissues, including the eyes, brain, and spinal cord are very close to cancers in the nasopharynx. The dose of radiation delivered to the cancer is limited by tolerance of these normal tissues. Standard radiation treatment techniques using three or four radiation beams cannot avoid delivering some dose of radiation to these normal tissues that do not need to get radiation. Intensity Modulated Radiation Therapy (IMRT) uses many hundreds of computer-controlled radiation beams aimed at your cancer to try to lower the amount of radiation that normal tissues receive, while still delivering the desired amount of radiation to your cancer and to areas that your doctor thinks may have cancer cells.
  The doctors at Princess Margaret Hospital are conducting this study in order to test whether the use of IMRT techniques can improve the chance of controlling your cancer in the head and neck region.


Eligibility: Inclusion Criteria:
  -  Confirmed histopathologic diagnosis of nasopharyngeal squamous cell carcinoma requiring primary radiation
  -  less than 70 yrs of age
  -  Stage T1-T4; N0-N3; M0
  -  KPS less than 70
  -  no prior RT to H&N or chemotherapy for H&N
  -  no other malignancy except non-melanomatous skin cancer
  -  no distant mets
  -  no contraindication to RT or chemotherapy
  -  adequate organ function
  -  informed consent
  Exclusion Criteria
  -  Major medical or psychiatric illness, which would interfere with either completion of therapy and follow-up or with full and complete understanding of the risks and potential complications of the therapy.

Relevance to patient case: not relevant
Patient case: 68-year-old male with non-small cell carcinoma; genetic feature: MET

Clinical trial: Elderly NSCLC/D vs DP (JCOG0207)

Summary: To evaluate the efficacy of docetaxel-cisplatin combination in comparison to docetaxel alone for elderly patients with advanced non-small-cell lung cancer.

Detailed description: The Elderly Lung Cancer Vinorelbine Italian Study demonstrated the first evidence of the utility of chemotherapy in elderly patients with advanced non-small-cell lung cancer (NSCLC). In a large randomized trial, gemcitabine and vinorelbine failed to show any advantage over either agent alone. With the current evidence, single agent chemotherapy with a third-generation drug can be considered a recommended option for elderly patients with advanced NSCLC. A Japanese phase I/II study showed the activity (overall response rate 52%, median survival 12.4 months) and tolerability of weekly docetaxel/ cisplatin combination in patients older than age 75 years. There have been no randomized prospective trials dedicated to elderly NSCLC patients to evaluate tolerability and efficacy of platinum-based combination.
  Comparison: Single-agent weekly docetaxel versus weekly regimen of docetaxel-cisplatin combination for elderly advanced NSCLC.

Eligibility: Inclusion Criteria:
  1. histologically or cytologically proven non-small-cell lung cancer
  2. stage IV, or stage III disease ineligible for definitive radiotherapy
  3. 70 years or older
  4. ECOG PS 0-1
  5. Ineligible for standard platinum(bolus infusion)-containing combination chemotherapy
  6. No prior chemotherapy(containing gefitinib) for non-small cell lung cancer or other neoplasms
  7. No prior surgery within 4 weeks before enrollment
  8. No prior radiotherapy for primary tumor
  9. No prior radiotherapy for metastatic lesions within 2 weeks before enrollment
  10. Adequate organ function
  11. Signed informed consent
  Exclusion Criteria:
  1. Symptomatic brain metastasis
  2. Active another neoplasms
  3. Severe SVC syndrome
  4. Massive pericardial, pleural effusion, or ascites
  5. Bone metastasis emergent for palliative radiotherapy or surgery
  6. Uncontrollable systemic hypertension
  7. Heart failure, Unstable angina, Myocardial infarction within 6 months
  8. Uncontrollable diabetes
  9. Active infection
  10. Interstitial pneumonia/ Pulmonary fibrosis
  11. Hypersensitivity for polysorbate 80
  12. Systemic administration of corticosteroids

Relevance to patient case: not relevant
Patient case: 68-year-old male with non-small cell carcinoma; genetic feature: MET

Clinical trial: Gemcitabine/Platinum Containing Regimens as Preoperative Chemotherapy for Patients With Non Small Cell Lung Cancer

Summary: To study the efficacy and tolerability of gemcitabine/platinum chemotherapy in non small cell lung cancer


Eligibility: Inclusion Criteria:
  -  Histologically of cytologically confirmed non small cell lung cancer
  -  No prior chemotherapy or radiation
  -  No prior malignancy
  Exclusion Criteria:
  -  Pregnant or breastfeeding
  -  Serious concomitant systemic disorder

Relevance to patient case: not relevant
Patient case: 68-year-old male with non-small cell carcinoma; genetic feature: MET

Clinical trial: OSI-774 and Bevacizumab in the Treatment of Patients With Metastatic Renal Cell Carcinoma

Summary: In this phase II trial, we plan to evaluate the combination of Tarceva and Avastin in the treatment of patients with metastatic renal cell carcinoma. This trial will be one of the first phase II trials to evaluate a combination of targeted agents in the treatment of a common solid tumor with a strong biologic rationale based on Cancer Biology (VHL/HIF/VEGF/EGFr).

Detailed description: Upon determination of eligibility, all patients will receive:
  Tarceva + Avastin

Eligibility: Inclusion Criteria:
  To be included in this study, you must meet the following criteria:
  -  Metastatic or unresectable clear cell kidney cancer confirmed by biopsy
  -  Previous nephrectomy
  -  Maximum of 1 previous regimen for metastatic disease
  -  Ability to perform activities of daily living with minimal assistance
  -  Measurable disease
  -  Adequate bone marrow, liver and kidney function
  -  Give written informed consent prior to study entry
  Exclusion Criteria:
  You cannot participate in this study if any of the following apply to you:
  -  Age < 18 years
  -  Treatment with more than one previous regimen for metastatic disease
  -  Clinically significant cardiovascular disease
  -  Active brain metastases
  -  History of CNS disease
  -  Clinical history of coughing or vomiting blood.
  -  History of thromboembolic disease.
  -  PEG or G-tube are ineligible.
  -  Current use of full dose anticoagulants or thrombolytic agents
  -  Chronic daily treatment with aspirin or NSAIDS
  -  Any clinical evidence or history of a bleeding or clotting disorder
  Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

Relevance to patient case: not relevant
Patient case: 68-year-old male with non-small cell carcinoma; genetic feature: MET

Clinical trial: Pharmacogenomic Study Realized on "Non-small Cell Lung Carcinoma"

Summary: The purpose of this study is to correlate molecular genetic profile with response to chemotherapy in case of primary chemotherapy treatment for non-small cells lung carcinoma.

Detailed description: Lung carcinoma will be the fifth death cause in the world in 2020. In Europe it causes more deaths than carcinoma of breast, colon and prostate combined so it is a public healthcare priority. Applying high throughput molecular analysis technologies to pharmacogenomics could improve lung carcinoma care strategies. The study hypothesis is that the determination of the genomic and proteomic profiles of non-small cell lung carcinoma patients will allow treatment targeting , improving treatment efficacy and tolerance.
  In order to carry out this study, the five thoracic oncology centers of the Rhône-Alpes region will collaborate with several INSERM (French national research institute) units and new biotechnology companies.
  The primary objective of this study is to correlate molecular genetic profile with response to chemotherapy in cases of primary chemotherapy treatment for non-small cell lung carcinomas.
  Biological samples will be collected before and during patient care to correlate clinical evolution (response and tolerance) with:
  -  circulating cell polymorphism profile
  -  proteomic profile
  -  genetic and epigenetic modifications of genes involved in DNA repair, drugs metabolism, apoptosis cell regulation mechanisms, and cell mobility and adhesion mechanisms.
  The main judgment criteria will be response to chemotherapy correlated with patient's biological profile.
  Second judgment criteria will be overall survival and hematology toxicity which will be evaluated each new cycle of chemotherapy.
  The second purpose of this study is to validate less invasive methods of sampling using blood, expectoration, urine, fixed biopsies and lungs tapping, as a substitute to the current reference (frozen tumor), which is out of reach in clinical examination.
  This will contribute to setting of a multicentric resources bank, to define targets for new drugs and to develop oligoarrays allowing adapted chemotherapies.
  Two previous studies (1800 and 500 patients respectively) have already been carried out, data and samples are available.
  For this study, 600 patients will be included over 3 years.

Eligibility: Inclusion Criteria:
  -  Patient older than 18 suffering from Non-Small-Cell Lung Carcinoma
  -  Patient treated by chemotherapy with platinum salt
  -  Every stage TNM classification
  -  No previous chemotherapy
  -  One measurable lesion out of nervous central system at least
  -  Performance status from 0 to 2 on ECOG scale
  -  Life expectancy > 12 weeks
  Exclusion Criteria:
  -  Previous or Concomitant carcinoma over 5 last years
  -  Concomitant radiotherapy
  -  Cardiac disease

Relevance to patient case: not relevant
Patient case: 68-year-old male with non-small cell carcinoma; genetic feature: MET

Clinical trial: Iressa vs Best Supportive Care - 2nd/3rd Line Survival Study

Summary: This study is being carried out to see if adding ZD1839 to other standard supportive care is more effective than standard supportive care alone for the treatment of patients with NSCLC whose disease has recurred after previous chemotherapy treatment.


Eligibility: Inclusion Criteria:
  -  · Life expectancy of at least 8 weeks.
  -  Histologically or cytologically confirmed non-small cell bronchogenic carcinoma: adenocarcinoma (including bronchoalveolar), squamous cell carcinoma, large cell carcinoma or mixed (adenocarcinoma and squamous) or undifferentiated carcinoma
  -  Not suitable for chemotherapy
  -  WHO Performance status 0,1, 2 or 3
  Exclusion Criteria:
  -  Newly diagnosed CNS mets
  -  Less than 1 week since completion of prior radiotherapy or persistence of any radiotherapy related toxicity
  -  ALT/AST greater than 5 x upper limit of normal
  -  ANC less than 1.0 x 109/L or platelets less than 100 x 109/L

Relevance to patient case: not relevant
Patient case: 68-year-old male with non-small cell carcinoma; genetic feature: MET

Clinical trial: Quality of Life in Patients Who Are Receiving Either Vinorelbine, Gemcitabine, and Docetaxel or Paclitaxel and Carboplatin for Advanced Non-Small Cell Lung Cancer

Summary: RATIONALE: Studying quality-of-life in patients undergoing cancer treatment may help identify the intermediate and long-term effects of treatment on patients with cancer.
  PURPOSE: This clinical trial is studying quality of life in patients who are receiving either vinorelbine, gemcitabine, and docetaxel or paclitaxel and carboplatin for advanced non-small cell lung cancer.

Detailed description: OBJECTIVES:
  -  Compare the quality of life of patients with advanced non-small cell lung cancer treated with vinorelbine, gemcitabine, and docetaxel vs paclitaxel and carboplatin on protocol JMTO-LC00-03.
  OUTLINE: This is a multicenter study. Patients receive treatment on protocol JMTO-LC00-03.
  Quality of life is assessed using the Functional Assessment of Cancer Therapy-Lung (FACT-L), FACT-Taxane, and Functional Assessment of Chronic Illness Therapy-Spirituality (FACIT-Sp) questionnaires at baseline, weeks 9 and 18, and at the completion of treatment.
  PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically or cytologically confirmed primary non-small cell lung cancer, including any of the following:
  -  Newly diagnosed selected stage IIIB (T4 lesion due to malignant pleural effusion) disease
  -  Newly diagnosed stage IV disease
  -  Recurrent disease after prior surgery and/or radiotherapy
  -  Any of the following cellular subtypes are allowed:
  -  Adenocarcinoma
  -  Large cell carcinoma
  -  Squamous cell carcinoma
  -  Unspecified carcinoma
  -  Enrolled on protocol JMTO-LC00-03
  PATIENT CHARACTERISTICS:
  Performance status
  -  Zubrod 0-1
  Life expectancy
  -  Not specified
  Hematopoietic
  -  Not specified
  Hepatic
  -  Not specified
  Renal
  -  Not specified
  PRIOR CONCURRENT THERAPY:
  Radiotherapy
  -  See Disease Characteristics
  Surgery
  -  See Disease Characteristics

Relevance to patient case: not relevant
Patient case: 68-year-old male with non-small cell carcinoma; genetic feature: MET

Clinical trial: A Trial of Postoperative Whole Brain Radiation Therapy vs. Salvage Stereotactic Radiosurgery Therapy for Metastasis

Summary: The aim of this study is to evaluate non-inferiority of salvage stereotactic radiosurgery (SRS) in the patients who received surgical resection for brain metastases in comparison with postoperative whole brain radiation therapy (WBRT).

Detailed description: A randomized phase III study is started in Japan to compare postoperative whole brain radiation therapy with salvage stereotactic radiosurgery in patient with one to four brain metastases from lung, breast, and colorectal cancer.
  Total of 270 patients will be accrued for this study from 21 institutions within three years. The primary endpoint is overall survival. The secondary endpoints are proportion of performance status (PS) preservation, proportion of mini-mental status examination (MMSE) preservation, and adverse events.

Eligibility: Inclusion Criteria:
  1. one to four brain metastases with a maximum diameter of 3 cm or more for the largest lesion and additional lesions not exceeding 3 cm in diameter
  2. all brain metastases localized within cerebrum or cerebellum
  3. before surgical resection for brain metastasis, PS is 0-2, or 3 by cerebral nerve compression neurological deficits
  4. surgical resection for the largest brain metastases has achieved
  5. after surgical resection, four or fewer (0-4) residual lesions with maximum diameter under 3 cm
  6. histologically proven non-small cell carcinoma, breast cancer or colorectal cancer
  7. primary lesion and the other metastases (i.e. lung, liver, bone metastases except for brain) is consider to be controlled
  8. an age of 20-79 years
  9. no prior surgery or irradiation for brain
  10. adequate organ function
  11. written informed consent(If signing in consent form is difficult for the patient due to paralysis, signing by the family in place of the patient is permitted)
  Exclusion Criteria:
  1. synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ or mucosal cancer
  2. pregnant or breast-feeding women
  3. severe mental disease
  4. allergic to gadolinium contained contrast agents

Relevance to patient case: not relevant
Patient case: 68-year-old male with non-small cell carcinoma; genetic feature: MET

Clinical trial: Lomustine in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer

Summary: RATIONALE: Drugs used in chemotherapy, such as lomustine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
  PURPOSE: This phase II trial is studying how well lomustine works in treating patients with stage III or stage IV non-small cell lung cancer.

Detailed description: OBJECTIVES:
  Primary
  -  Evaluate the response rate to lomustine in patients with stage IIIB or IV non-small cell lung cancer with aberrant methylation of the MGMT gene.
  -  Determine whether the response rate in these patients is significantly greater than that of the historical control.
  Secondary
  -  Collect preliminary data on toxicity, disease stabilization, time to disease progression, and overall survival.
  Tertiary
  -  Evaluate the association between clinical outcome and immunohistochemical staining by grouping the patients as complete or partial loss of MGMT gene.
  OUTLINE: This is a multicenter study.
  Patients receive oral lomustine once on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
  After completion of study treatment, patients are followed every 3 months.
  PROJECTED ACCRUAL: A total of 42 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically confirmed non-small cell bronchogenic carcinoma, including the following histologic subtypes:
  -  Squamous cell
  -  Adenocarcinoma
  -  Adenosquamous
  -  Large cell anaplastic
  -  Bronchoalveolar
  -  Non-small cell carcinoma not otherwise specified (NOS)
  -  Stage IIIB disease (with a pleural effusion) or stage IV disease
  -  Stage IV patients with brain metastases are eligible provided the brain metastases are clinically stable after treatment with surgery and/or radiation therapy
  -  Tumors must test positive for aberrant methylation of the MGMT gene by methylation-specific polymerase chain reaction
  -  Bidimensionally measurable or evaluable disease
  PATIENT CHARACTERISTICS:
  -  ECOG performance status 0-2
  -  No other active malignancies
  -  WBC ≥ 4,000/mm^3 OR absolute neutrophil count ≥ 2,000/mm^3
  -  Platelet count ≥ 100,000/mm^3
  -  Total bilirubin normal
  -  AST < 5 times upper limit of normal
  -  Serum creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 60 mL/min
  -  No uncontrolled serious active infection
  -  Not pregnant or nursing
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics
  -  More than 3 weeks since prior chemotherapy
  -  No more than 2 prior chemotherapy regimens
  -  No prior therapy with nitrosoureas
  -  Recovered from prior radiation therapy

Relevance to patient case: not relevant
Patient case: 68-year-old male with non-small cell carcinoma; genetic feature: MET

Clinical trial: Effects Of Nadroparin In Patients With Lung, Pancreas Or Prostate Cancer

Summary: This study will evaluate the effects of nadroparin on survival and disease progression in patients with hormone-refractory prostate cancer (HRPC), locally advanced pancreatic cancer or non-small-cell lung carcinoma (NSCLC).


Eligibility: Inclusion criteria:
  -  Hormone refractory prostate cancer within 6 months of diagnosis, OR locally advanced (non-metastasized) pancreatic cancer within 3 months of diagnosis, OR non-small-cell lung cancer within 3 months of stage IIIB.
  Exclusion criteria:
  -  Life expectancy of <3 months.
  -  Poor performance status (Karnofsky <60).
  -  Need to be on anticoagulants.
  -  Use of nadroparin (a low molecular weight heparin) for any reason including a history of heparin-induced thrombocytopenia.
  -  Have brain metastasis.
  -  At a high risk of bleeding or have a platelet count <50,000/mm3.
  -  Have very poor kidney function.

Relevance to patient case: not relevant