araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 67-year-old male with esophageal cancer; genetic feature: EGFR

Clinical trial: Chemoradiation Versus Esophagectomy for Locally Advanced Esophageal Cancer

Summary: The aim of this study is to compare outcomes in Chinese patients with locally advanced resectable esophageal squamous cell cancer who have received either surgery or definitive chemoradiation (CRT) by the randomized, open-label, multicenter trial.

Detailed description: Background: More than half of global esophageal cancer cases came from China, but the report about definitive chemoradiation (CRT) compared with esophagectomy in Chinese patients with locally advanced resectable esophageal squamous cell cancer (ESCC) is limited.
  Aim: to compare outcomes in Chinese patients with locally advanced resectable esophageal squamous cell cancer who have received either surgery or definitive chemoradiation (CRT).
  Methods: 176 ESCC patients with T1bN+M0, T2-4aN0-2M0 will be randomized to CRT group or Surgery group.In the CRT group, patients will be given intensity modulation radiation therapy (IMRT) with 50Gy/25 fractions , and current chemotherapy with 5-fluorouracil (5-FU) basic regimens. In the surgery group, patients will received standard esophagectomy. 5 years follow-up for both groups patients.
  Primary endpoints: 2 year and 5 year Disease free survival, Overall survival Second endpoints: treatment-related adverse events; the quality of life

Eligibility: Inclusion Criteria:
  -  Chinese
  -  esophageal squamous cell cancer
  -  mid or lower esophageal cancer
  -  tumor is resectable disease
  -  clinical stage: cT1bN+Mo, or cT2-4aN0-2M0
  Exclusion Criteria:
  -  who had distant metastasis to solid visceral organs or local invasion into trachea, descending aorta, or recurrent laryngeal nerve.
  -  who had a serious premorbid condition or a poor physical status that compromised a thoracotomy.

Relevance to patient case: not relevant
Patient case: 67-year-old male with esophageal cancer; genetic feature: EGFR

Clinical trial: EGFR-TKI With/Without Chemotherapy in NSCLC Patients With Both EGFR Mutation and BIM Deletion Polymorphism

Summary: BIM deletion polymorphism might be associated with a poor clinical response to EGFR-TKIs in patients who had NSCLC with EGFR mutations. In the study, the investigators want to use EGFR-TKI with/without chemotherapy as first line treatment in stage IIIB/IV NSCLC patients with both EGFR mutation and BIM deletion polymorphism.

Detailed description: BIM deletion polymorphism was a poor clinical response marker to EGFR-TKIs in NSCLC patients who had EGFR mutations. In the study, the investigators want to use EGFR-TKI with chemotherapy as 1 st treatment in stage IIIB/IV NSCLC patients with both EGFR mutation and BIM deletion polymorphism.

Eligibility: Inclusion Criteria:
  1. Signed informed consent
  2. Histologically documented, unresectable, inoperable, locally advanced, recurrent or metastatic Stage IV Non-Small Cell Lung Cancer (NSCLC)
  3. Must have measurable or non-measurable disease
  4. Must be able to comply with study and follow-up procedures
  Exclusion Criteria:
  1. Small cell, carcinoid, or mixed small cell lung cancer
  2. Malignancies within 3 years except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer
  3. Symptomatic or untreated brain metastases Prior systemic chemotherapy for NSCLC
  4. Unstable systemic disease, including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, or myocardial infarction within 6 months prior to Day 1, or serious cardiac arrhythmia requiring medication
  5. History of other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the results of the study or render the patient at high risk from treatment complications
  6. Gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for intravenous (IV) alimentation, or prior surgical procedures affecting absorption
  7. Pregnancy or lactation

Relevance to patient case: not relevant
Patient case: 67-year-old male with esophageal cancer; genetic feature: EGFR

Clinical trial: Endostar Plus EGFR-TKI（Epidermal Growth Factor Receptor—Tyrosine-Kinase Inhibitor） as a Treatment of EGFR Mutation-positive NSCLC

Summary: EGFR Tyrosine-Kinase Inhibitor monotherapy is widely used in treatment of patients with EGFR mutation-positive Non-small cell lung cancer(NSCLC), In despite of the benefit of PFS （progression-free survival） , the OS （ overall survival） is limited extended. This study is aim to observe the safety and efficacy of the combination of an anti-angiogenic drug recombinant human-endostatin with EGFR TKI ,to find out a new strategy which may further extend the PFS and OS with a tolerated toxicity.


Eligibility: Inclusion Criteria:
  -  Advanced NSCLC,EGFR mutation positive,PS（performance status） 0-2,Patients were required to have one or more measurable lesions
  Exclusion Criteria:

Relevance to patient case: not relevant
Patient case: 71-year-old female with lung cancer; genetic feature: ROS1

Clinical trial: Radiofrequency Ablation in Treating Patients With Refractory or Advanced Lung Cancer

Summary: RATIONALE: Radiofrequency ablation uses high-frequency electric current to kill tumor cells. CT-guided radiofrequency ablation may be effective treatment for lung cancer.
  PURPOSE: Phase II trial to study the effectiveness of radiofrequency ablation in treating patients who have refractory or advanced lung cancer.

Detailed description: OBJECTIVES:
  -  Determine the safety and toxicity of radiofrequency ablation in patients with refractory or advanced pulmonary malignancies.
  -  Determine the efficacy of this treatment, in terms of local control, in these patients.
  -  Determine whether CT scan is a reasonable imaging assessment tool for treatment delivery and follow-up in these patients.
  OUTLINE: Patients undergo percutaneous CT-guided radiofrequency ablation directly to the tumor over 2 hours.
  Patients are followed at 1, 3, 6, and 12 months.
  PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

Eligibility: Inclusion Criteria:
  -  Diagnosis of a primary or secondary intrathoracic malignancy
  -  Any cell type or origin
  -  Involving the intrapulmonary, mediastinal, or pleural/chest wall
  -  Inoperable primary or metastatic cancer to the lung
  -  Refractory to or not amenable to conventional therapy (e.g., surgery, chemotherapy, or radiotherapy)
  -  Single or multiple lesions that are non-contiguous with vital structures or organs such as:
  -  Trachea
  -  Heart
  -  Aorta
  -  Great vessels
  -  Esophagus
  -  Less than 5 cm in largest dimension
  -  Accessible via percutaneous transthoracic route
  -  Hepatic:
  -  Coagulation profile normal

Relevance to patient case: not relevant
Patient case: 71-year-old female with lung cancer; genetic feature: ROS1

Clinical trial: Radiofrequency Ablation During Surgery in Treating Patients With Non-Small Cell Lung Cancer

Summary: RATIONALE: Radiofrequency ablation uses high-frequency electric current to kill tumor cells. Combining radiofrequency ablation with surgery may kill more tumor cells.
  PURPOSE: Phase II trial to study the effectiveness of combining radiofrequency ablation with surgery in treating patients who have stage I or stage II non-small cell lung cancer.

Detailed description: OBJECTIVES:
  -  Determine the acute effects of intraoperative radiofrequency tumor ablation (RFA) in patients with resectable non-small cell lung cancer.
  -  Determine the treatment-related toxicity in patients treated with this therapy.
  -  Determine the dimensions of the RFA lesion produced by the ablation procedure in these patients.
  OUTLINE: Patients undergo intraoperative radiofrequency tumor ablation over 10-15 minutes for each tumor immediately followed by tumor resection.
  PROJECTED ACCRUAL: A maximum of 20 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of malignant non-small cell lung cancer (NSCLC)
  -  Intraoperative needle biopsy confirmation allowed
  -  Resectable disease (stage I or II)
  -  All tissue to be treated by radiofrequency tumor ablation must be completely contained within boundaries of planned lung resection
  -  Medically fit to undergo lung resection
  PATIENT CHARACTERISTICS:
  Age:
  -  Over 18
  Performance status:
  -  Not specified
  Life expectancy:
  -  Not specified
  Hematopoietic:
  -  Not specified
  Hepatic:
  -  Not specified
  Renal:
  -  Not specified
  Other:
  -  Not pregnant or nursing
  PRIOR CONCURRENT THERAPY:
  Biologic therapy:
  -  No prior or concurrent biologic therapy
  Chemotherapy:
  -  No prior or concurrent chemotherapy
  Endocrine therapy:
  -  No prior or concurrent endocrine therapy
  Radiotherapy:
  -  No prior or concurrent radiotherapy
  Surgery:
  -  See Disease Characteristics
  Other:
  -  No other prior therapy for NSCLC

Relevance to patient case: not relevant
Patient case: 71-year-old female with lung cancer; genetic feature: ROS1

Clinical trial: Celecoxib Treatment for Lung Cancer

Summary: This proposal evaluates cyclooxygenase 2 (COX-2) inhibition as a means to decrease T regulatory cell activities and thus augment immune responses against lung cancer. The broad goal focuses on understanding how COX-2 expression regulates the malignant phenotype in non small cell lung cancer in an effort to foster an informed approach for the use of COX-2 inhibitors in prevention and therapy for lung cancer.


Eligibility: Inclusion Criteria:
  -  Pathologically confirmed and surgically resectable non small cell lung cancer and subjects must be ineligible for or refuse, neoadjuvant therapy
  Exclusion Criteria:
  Hypersensitivity to celecoxib or NSAIDs, previous history of GI bleeding or ulceration, chronic or concurrent use of steroids and renal insufficiency

Relevance to patient case: not relevant
Patient case: 71-year-old female with lung cancer; genetic feature: ROS1

Clinical trial: A Clinical Trial of Oral Suberoylanilide Hydroxamic Acid (SAHA) in Patients With Relapsed or Refractory Breast, Colorectal and Non-Small Cell Lung Cancer (0683-011)(TERMINATED)

Summary: This is an investigational study to determine the response rate of relapsed/refractory breast, colorectal and non-small cell lung cancer to oral suberoylanilide hydroxamic acid (SAHA), to evaluate PET as an earlier indicator of response to SAHA as assessed by response evaluation criteria in solid tumours (RECIST) criteria and to evaluate the safety and tolerability of oral suberoylanilide hydroxamic acid.


Eligibility: Inclusion Criteria:
  -  Patient must be 18 years or older with confirmed diagnosis of breast adenocarcinoma, colorectal carcinoma or non-small cell lung cancer
  -  Patients must have relapsed or refractory disease following at least one chemotherapeutic treatment regimen.
  -  Has a measurable, positron emission tomography (PET) assessable lesion
  -  Adequate blood, liver, bone marrow and kidney functions
  -  Has not received any chemotherapy for at least 4 weeks prior to entry in this study
  -  Agrees to take adequate measures to prevent pregnancy.
  Exclusion Criteria:
  -  Patient has had prior treatment with histone deacetylase (HDAC) inhibitor.
  -  Patient has had treatment with investigational agents within the last 30 days.
  -  Patient has active infection or had intravenous (IV) antibiotic, antiviral, or antifungal medications within 2 weeks of the start of study drugs.
  -  Patient has HIV, hepatitis B or hepatitis C infection.
  -  Patient is pregnant or lactating.
  -  Patient has allergy to any component of the study drug.

Relevance to patient case: not relevant
Patient case: 71-year-old female with lung cancer; genetic feature: ROS1

Clinical trial: Self-Gated Breath-Hold Technique for Helical Tomotherapy in Patients With Non-Small Cell Lung Cancer

Summary: Non-small cell lung cancer (NSCLC) is a disease that often cannot be surgically operated on. As a result, treating the tumor with radiation has become the main standard of treatment. Radiation therapy though, is limited by various factors, including the difficulty in properly imaging the lung tumor since the lung can move up to 4 cm between breathing in and out. Consequently, a radiation oncologist must consider a larger area of the lung to treat with radiation - increasing the amount of normal tissue exposed to harmful rays and therefore leading to increased side-effects. Two techniques being explored into improving tumor management while minimizing the side effects in NSCLC are breath-held gating and tomotherapy. Breath-held gating is a technique for consistently imaging the tumor at the right moment in a patient's breathing cycle - decreasing the normal tissue exposed to harmful radiation. Tomotherapy, a new technique in delivering radiation, will further allow the investigators to focus treatment on the tumor and exclude more normal tissues. Therefore, they hope that these methods will prove to be a better way in treating people with NSCLC.

Detailed description: Non-small cell lung cancer (NSCLC) is a disease that often presents as an unresectable tumor. As a result, radiotherapy is the main standard of treatment. Unfortunately, radiotherapy is limited by several factors, including that the lung can move up to 4 cm between inspiration and expiration. As a result, a radiation oncologist often has to widen his treatment field to include for this motion. This leads to greater side effects for the patient. Two techniques that are being explored to improve the tumor control of radiotherapy and to minimize side effects to normal tissues in NSCLC treatment include breath-held gating and tomotherapy. Breath-held gating will allow the investigators to treat patients at the right moment in their breathing cycle consistently - minimizing the normal tissue exposed to radiation. In addition, both gated breathing and tomotherapy will allow the investigators to create a more refined tumor volume treated and exclude more of the normal tissues. Consequently, they hope these methods will prove to be a better way to treat patients with non-resectable NSCLC.

Eligibility: Inclusion Criteria:
  -  Stage I-III NSCLC
  -  Karnofsky Performance Status (KPS) equal to or greater than 70
  -  Forced expiratory volume in 1 second (FEV1) equal to or greater than 1.0L
  Exclusion Criteria:
  -  Myocardial infarction (MI) disease
  -  Recurrent disease
  -  Complete tumour resection

Relevance to patient case: not relevant
Patient case: 71-year-old female with lung cancer; genetic feature: ROS1

Clinical trial: SERPIN D1 and Its Role in Lung Cancer Invasion and Metastasis

Summary: To evaluate the correlation between SERPIN D1 expression in clinical specimen (including surgical specimen and blood sample) and lung cancer metastasis.

Detailed description: Lung cancer is the leading cause of cancer death in Taiwan and world wild. Although there were progresses in the diagnosis and treatment of lung cancer, the incidence and mortality rate of lung cancer increased in recent years. In many cases, lung cancer is not diagnosed and treated until cancer cells have already invaded surrounding tissues and metastasized throughout the body. Only 15% of lung cancer patients were operable at presentation and about half of them had long term survival. The remaining almost died of metastatic disease. Detecting lung cancers when they are at their earliest stages, and identify cancers with metastatic potential will have a higher probability of truly curing the disease. Molecules that are expressed uniquely or at high level by tumor cells in comparison to normal tissues and that may be secreted into accessible fluids such as blood, urine, or sputum may be useful as lung cancer biomarkers. By using tools in SAGE Genie of Cancer Genome Anatomy Project (CGAP), we identified a secreted protein, SERPIN D1, as an overexpressed gene in non-small cell lung cancer as compared with normal lung and any other normal tissue. In an established panel of human lung adenocarcinoma cell lines with different invasive activities (CL1–0 cells and its sublines CL1–1, and CL1–5, in ascending order of activity), we detected that the expression of SERPIN D1 was higher in CL1-5 than in CL1-0 and CL1-1. According to our preliminary results, we hypothesize that SERPIN D1 may play a role in lung cancer invasion and metastasis and may serve as a serum biomarker for prognosis stratification. For this study, we are going to evaluate the potential correlation between SERPIN D1 expression in clinical specimen (including surgical specimen and blood sample) and lung cancer metastasis.

Eligibility: Inclusion Criteria:
  -  non-small cell lung cancer patient, pathological proved
  Exclusion Criteria:

Relevance to patient case: not relevant
Patient case: 71-year-old female with lung cancer; genetic feature: ROS1

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: 71-year-old female with lung cancer; genetic feature: ROS1

Clinical trial: Lung Cancer Case Registry and Tissue Resource

Summary: Potential participants in the Lung Cancer Case Registry will be all patients diagnosed or evaluated for possible treatment of lung cancer at the Cancer Research and Treatment Center (CRTC) and New Mexico Veterans Health Care System (NMVHCS).

Detailed description: Lung cancer is the most common cause of cancer death in the US in both men and women. This research study will enroll lung cancer patients into a registry to study changes in DNA (or genetic material) that may be associated with development of lung cancer or other lung diseases such as chronic obstructive pulmonary disease (COPD). We will also study the role of eating habits on lung cancer diagnosis and treatment, as well as the effects of the disease and treatment on quality of patient's lives.

Eligibility: Inclusion Criteria:
  -  Potential participants in the Lung Cancer Case Registry will be all patients diagnosed or evaluated for possible treatment of lung cancer at the CRTC and NMVHCS. Recruiting will primarily be performed through the Multidisciplinary Chest Clinics held weekly at each hospital. These clinics are staffed by the Principal Investigator (PI) and Reza Mehran, MD, a thoracic surgeon at both hospitals and a co-investigator on this submission. Approximately 90% of all lung cancer cases diagnosed at the NMVHCS, and a somewhat smaller proportion of cases treated in the Cancer Center, are seen in these clinics. Additional cases will be identified through review of new patient visits to each hospital with a diagnosis of lung cancer; Drs. Crowell and Mehran also maintain weekly contact with pathology and oncology services at both facilities, which will facilitate case identification at NMVHCS and University Hospital. Finally, patient contact records will be correlated with tumor registry records at both hospitals, which will identify any cases not captured through the above mechanisms. Although these cases may be identified several weeks after initial diagnosis, all attempts will still be made to contact the patient and family for enrollment into the registry. Most Spanish-speaking patients served by the CRTC and the NMVHCS are bilingual, and a language barrier has not been a problem in other similar studies conducted by the PI. However, Spanish-speaking personnel are available to obtain consent and answer any questions if necessary.
  Exclusion Criteria:
  -  Patients will be excluded if they cannot provide written informed consent.

Relevance to patient case: not relevant
Patient case: 71-year-old female with lung cancer; genetic feature: ROS1

Clinical trial: LUCY: A Study for the Treatment of Non-Small Cell Lung Cancer (NSCLC) in Patients Previously Treated With Chemotherapy

Summary: A study for the treatment of Non-Small Cell Lung Cancer (NSCLC) in patients previously treated with chemotherapy.


Eligibility: Inclusion Criteria:
  -  Histologically or cytologically confirmed non-small cell lung cancer.
  -  Prior chemotherapy regimen(s) for lung cancer
  Exclusion Criteria:
  -  History of other malignancy in the last 5 years
  -  Major surgery within the past 21 days

Relevance to patient case: not relevant