araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 71-year-old female with lung cancer; genetic feature: ROS1

Clinical trial: Study of PXD101 Alone and in Combination With 5-Fluorouracil (5-FU) in Patients With Advanced Solid Tumors

Summary: This is a study to assess the combination of PXD101 and 5-Fluorouracil (5-FU)in patients with advanced solid tumors. The primary goal of the study is to understand the safety, anti-tumor activity, and how the study drug behaves within the body when given with 5-Fluorouracil (5-FU).


Eligibility: Inclusion Criteria:
  -  Histologically confirmed solid tumors
  -  Advanced colorectal cancer or other adenocarcinomas
  -  Tumor progression after standard chemotherapy, or where none yet approved
  -  At least one unidimensionally measurable lesion
  -  Karnofsky performance >= 70%
  -  Life expectancy of at least 3 months
  -  Age >= 18 years
  -  Signed, written Institutional Review Board (IRB)-approved informed consent
  -  Acceptable liver function:
  -  Bilirubin <= 1.5 x upper limit of normal (ULN)
  -  AST (SGOT) and ALT (SGPT) <= 2.5 x ULN, OR
  -  AST (SGOT) and ALT (SGPT) <= 5 x ULN if liver metastasis
  -  Acceptable renal function:
  -  Serum creatinine within normal limits, OR
  -  Calculated creatinine clearance of >= 60 mL/min/1.73 m2 for certain patients
  -  Acceptable hematologic status:
  -  Absolute neutrophil count (ANC) >= 1500 cells/mm3
  -  Platelet count >= 100,000 (plt/mm3)
  -  Hemoglobin >= 9 g/dL
  -  Urinalysis: No clinically significant abnormalities
  -  Acceptable coagulation status:
  -  Prothrombin time (PT)/partial thromboplastin time (PTT) within normal limits, OR
  -  For patients on anticoagulation therapy, status within therapeutic range
  -  For men and women of child-producing potential, use of effective contraception
  -  Tumors accessible for needle biopsy
  Exclusion Criteria:
  -  Significant cardiovascular disease.
  -  A marked baseline prolongation of QT/QTc interval
  -  Long QT syndrome
  -  Required use of medication on dosing days that may cause torsade de pointes.
  -  Infections requiring intravenous (IV) systemic therapy
  -  Pregnant or nursing women
  -  Treatment with chemotherapy or investigational therapy < 4 weeks (28 days) prior to study entry (6 weeks for nitrosoureas, mitomycin C, or Avastin).
  -  Treatment with radiation therapy or surgery either within 2 weeks prior to study entry, or not yet recovered if 2-4 weeks prior to study entry.
  -  Unwillingness or inability to comply with protocol procedures.
  -  Known active uncontrolled infection with HIV, hepatitis B, or hepatitis C
  -  Serious nonmalignant disease (e.g. hydronephrosis, liver failure, or other conditions) that could compromise protocol objectives in the opinion of the investigator and/or the sponsor
  -  Concurrent use of other investigational agent(s)
  -  Serious concurrent medical illness

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

Clinical trial: Phase II Study of Irinotecan/Capecitabine in Patients With Antracycline/Taxane Pretreated MBC

Summary: To evaluate the response rate of capecitabine and irinotecan combination therapy in patients with metastatic breast cancer

Detailed description: This is a nonrandomized, open-label, phase II study of irinotecan plus capecitabine in patients with metastatic breast cancer previously treated with anthracyclines and taxanes. Up to 44 qualified patients will be enrolled according to the exact single stage design.
  Irinotecan 90 mg/m2 intravenously for 90 minutes once a week for 2 weeks (Days 1 and 8) followed by 1-week rest period. Capecitabine is administered orally at a dose of 1,000 mg/m2 twice daily (total daily dose 2,000 mg/m2) as an intermittent regimen in 3-week cycles (2 weeks of treatment followed by a 1-week rest period). For practical reasons, capecitabine doses are rounded to the nearest dose that could be administered with a combination of 500-mg and 150-mg tablets of drug. Capecitabine is given approximately 12 hours apart and taken orally with water within 30 minutes after ingestion of food (breakfast or dinner).

Eligibility: Inclusion Criteria:
  -  Histologic or cytologic diagnosis of breast cancer Stage IV or recurrent.
  -  Previous chemotherapy with anthracyclines and taxane in adjuvant setting
  -  Previous hormonal therapy in adjuvant and metastatic setting is allowed
  -  Prior radiation therapy is allowed as long as the irradiated area is not the only source of measurable disease.
  -  No other forms of cancer therapy, such as radiation, immunotherapy for at least 3 weeks before the enrollment in study.
  -  Performance status of 0, 1, 2 on the ECOG criteria.
  -  Clinically measurable disease, defined as uni-dimensionally measurable lesions with clearly defined margins on x-ray, CT scan, MRI or physical examination. Lesions serving as measurable disease must be at least 1 cm, as defined by x-ray, CT scan, MRI, or physical examination.
  -  Estimated life expectancy of at least 12 weeks.
  -  Patient compliance that allow adequate follow-up.
  -  Adequate hematologic (WBC count ³ 3,000/mm3, platelet count ³ 100,000/mm3), hepatic (bilirubin level £ 1.5 mg/dL), and renal (creatinine concentration £ 1.5 mg/dL) function.
  -  Informed consent from patient or patient's relative.
  -  Males or females at least 18 years of age.
  -  If female: childbearing women should use non-hormonal contraceptive method
  Exclusion Criteria:
  -  MI within preceding 6 months or symptomatic heart disease, including unstable angina, congestive heart failure or uncontrolled arrhythmia.
  -  Serious concomitant infection.
  -  Second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin or prior malignancy treated more than 5 years ago without recurrence).

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

Clinical trial: Lung Cancer Location: a Repository

Summary: The purpose of this repository is to prospectively examine subjects with known or suspected lung cancer to determine the extent of mediastinal lymph node involvement with respect to primary lung cancer location. The data collected in this repository may be used to influence our current standard of care and streamline indications for EUS.


Eligibility: Inclusion Criteria:
  -  Subjects undergoing EUS evaluation of a mediastinal mass, or suspected/known lung cancer
  -  Subjects with a prior history of lung cancer
  -  Subjects referred to thoracic surgery for evaluation of a suspected/known lung cancer
  Exclusion Criteria:
  -  Altered mental status that would prohibit the giving and understanding of informed consent
  -  Dementia
  -  Psychiatric illness that would preclude adequate compliance with communication for this protocol
  -  Prisoners

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

Clinical trial: A Study Of Oral PF-02341066, A C-Met/Hepatocyte Growth Factor Tyrosine Kinase Inhibitor, In Patients With Advanced Cancer

Summary: PF-02341066 may work in cancer by blocking the cell growth, migration and invasion of tumor cells. PF-02341066 is a new class of drugs called c-Met/Hepatocyte growth factor receptor tyrosine kinase inhibitors. This compound is also an inhibitor of the anaplastic lymphoma kinase (called ALK) tyrosine kinase and ROS receptor tyrosine kinases. This research study is the first time PF-02341066 will be given to people. PF-02341066 is taken by mouth daily.


Eligibility: Inclusion Criteria:
  -  Advanced malignancies (except leukemias), histologically proven at diagnosis; Histologically confirmed advanced malignancies that are known to be sensitive to PF-03241066 inhibition, e.g. ALK, c-MET and ROS
  -  Solid tumors must have measurable disease (Recommended Phase 2 Dose Cohort patients with non-measurable disease may enter on a case-by-case basis); not required for DDI sub-studies.
  -  Adequate blood cell counts, kidney function, liver function and Eastern Cooperative Oncology Group (ECOG) score of 0 or 1 (for the Recommended Phase 2 Cohort, a ECOG score of 2 may be allowed on a case-by-case basis)
  Exclusion Criteria:
  -  Major surgery, radiation therapy or anti-cancer therapy within 2 to 4 weeks of starting study treatment, depending on the patient cohort
  -  Prior stem cell transplant except of patients with neuroblastoma, lymphoma or myeloma
  -  Active or unstable cardiac disease or heart attack within 3 months of starting study treatment

Relevance to patient case: possibly relevant
Patient case: 71-year-old female with lung cancer; genetic feature: ROS1

Clinical trial: Phase II Trial to Correlate Radiographic Response Induced By Gefitinib With Mutations in the Protein-Tyrosine Kinase Domain of the EGF Receptor Gene

Summary: The purpose of this research study is to:
  -  see if gefitinib pills can shrink Stage 1 or 2 non-small cell lung cancers before surgery
  -  see if your non-small cell lung cancer has a mutation in a certain part of the EGFR gene
  -  see if patients whose tumor does shrink with gefitinib treatment are more likely to have a mutation in a certain part of the EGFR gene
  -  see if the pattern of protein expression in the blood is related to the tumor's sensitivity or resistance to gefitinib treatment.
  -  see if expression of certain genes in the tumor are related to the tumor's sensitivity or resistance to gefitinib treatment.

Detailed description: This is a phase II, single institution trial to correlate gefitinib response and mutations in the protein-tyrosine kinase domain of the EGF receptor gene. The study will be conducted in patients with Stage I and II NSCLC who have been determined to be operable and resectable.
  Patients must have 1 or more of the following features: never smoker or smoking history of < 15 pack years and/or features of bronchioloalveolar lung cancer. 50 patients will be enrolled on this study. Treatment will be with gefitinib for at least 21 days before surgery (depending on the timing of the surgery). Patients will discontinue gefitinib 2 days before their operation. For patients that demonstrate a radiographic response to gefitinib preoperatively and /or patients with mutations in the protein-tyrosine kinase domain of the EGF receptor gene (identified from the surgical sample), gefitinib will continue for 2 years post-surgery. Patients who do not have evidence of radiographic response or mutations in the protein-tyrosine kinase domain of the EGF receptor gene will be removed from the study.

Eligibility: Inclusion Criteria:
  -  Pathologic confirmation of malignancy at Memorial Sloan-Kettering
  -  Patients must have previously untreated stage I or II NSCLC (T11-2N0M0, T1-2N1M0, T3N0M0) and 1 of the following features: never smoker or < 15 pack year smoking history and/or bronchioloalveolar cancer (either pure BAC, BAC with focal invasion or adenocarcinoma with BAC features)
  -  Patients must have been determined to be operable and resectable by the treating thoracic surgeon.
  -  Age >18 years.
  -  Measurable indicator lesions
  -  Ability to understand and the willingness to sign a written informed consent document.
  Exclusion Criteria:
  -  Pregnant or lactating women or women of childbearing potential not using effective contraception. Men participating in the trial must also use effective contraception when sexually active.
  -  Patients may not be receiving any other investigational agents.
  -  Any history of or evidence of interstitial lung disease (patients with chronic stable radiographic changes who are asymptomatic need not be excluded).

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

Clinical trial: Preoperative Percutaneous Radiofrequency Ablation of Primary and Secondary Lung Tumors

Summary: The purpose of the study is to evaluate the effectiveness of radiofrequency ablation by pathological correlation and to characterize the tissue response after treatment of primary and secondary pulmonary tumors.

Detailed description: Thermal ablation therapy is an increasingly performed technique in the local tumor treatment. Among these techniques, image-guided radiofrequency (RF) ablation attained widespread consideration in the therapy of liver tumors and osteoid osteoma. Promising results of hepatic RF ablation raised expectations to utilize the advantages of image-guided ablation therapy for the treatment of pulmonary malignancies. The purpose of the study is to evaluate the effectiveness of radiofrequency ablation by pathological correlation and to characterize the tissue response after treatment of primary and secondary pulmonary tumors. Computed tomography-guided RF ablation is performed in local or general anesthesia, followed by surgical resection three days later. An analysis of complete RF ablation and a characterization of tissue response is performed by hematoxylin and eosin staining, immunostaining, and electron microscopy. Adverse effects and complications are recorded.

Eligibility: Inclusion Criteria:
  -  Signed informed consent for radiofrequency ablation and surgery
  -  Maximum of 3 lung tumors
  -  Maximum tumor size 5 cm
  -  Must be able to receive standard surgery
  Exclusion Criteria:
  -  Pathological coagulation tests
  -  Pregnant or breast feeding
  -  Maximum tumor size more than 5 cm
  -  Bilateral secondary lung cancer with more than 3 tumors
  -  Inoperable patient

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

Clinical trial: Quantifying Lung Tumor Movement Under Deep Inspiration Breath Holds

Summary: Radiotherapy is a common treatment for lung cancer. One Challenge of delivering radiation treatment to lung tumors accurately is tumor movement which occurs as a patient breathes. In some situations, tumors move enough during breathing so that some or all of the tumor may be missed by a radiation treatment. One way to decrease the amount a lung tumor moves during radiotherapy treatments is for patients to held their breath briefly during a radiation treatment. By doing this, a patient's lung tumor may not move as much as it would during regular breathing. In this study, the investigators aim to study patients with lung cancers which move during breathing. Patients will be asked to hold their breath after inspiration while a CT scan of their lung tumor is obtained. The purpose of this study is to study how much less patients' lung tumors move when they hold their breath


Eligibility: Inclusion Criteria:
  -  biopsy confirmed primary lung cancer
  -  undergoing radiotherapy or chemoradiotherapy
  -  able to perform adequate deep inspiration breath hold
  -  patients of childbearing potential must practice adequate contraception
  -  signed study-specific informed consent form
  Exclusion Criteria:
  -  unable to perform adequate deep inspiration breath hold
  -  prior tumor resection
  -  prior chest or neck RT
  -  pregnant

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

Clinical trial: The Effect of Berries on Lung Cancer Tumors

Summary: The purpose of this study is to determine how berries affect cancer tumors in patients with non-small cell lung cancer.

Detailed description: In the United States, more people (161,840 per year) die of lung cancers than of prostate cancer, breast cancer and colon cancer combined. Presently, there are over 43 million current smokers and over 47 million ex-smokers living in the US. Due to the lag time between smoking and the development of cancer, there are significant numbers of ex-smokers and current smokers who may develop lung cancer compared to never smokers.
  Recent studies in animals have shown that berries, given as a dietary supplement, are highly effective against certain types of cancers. In a study involving mice with lung tumors, mice that had consumed a mixture of berries developed fewer tumors and had less tumor growth than mice that did not consume berries.
  The berries used in this study will consist of blueberries, black raspberries, or a mixture of both.

Eligibility: Inclusion Criteria (lung cancer survivors):
  -  men treated for lung cancer, women treated for lung cancer and with no child-bearing potential (hysterectomy, tubal ligation, post-menopausal women)
  Exclusion Criteria (lung cancer survivors):
  -  women who are on hormone replacement therapy
  -  women who are pregnant, or planning for pregnancy
  -  history of lung transplant
  -  prison inmate
  -  inability to take oral medication or food
  -  known or suspected allergy to berries or berry products
  -  HIV patients
  Inclusion Criteria (volunteers):
  -  adult men, adult women with no child bearing potential (hysterectomy, tubal ligation, post-menopausal women)
  Exclusion Criteria (volunteers):
  -  women who are on hormone replacement therapy
  -  women who are pregnant, or planning for pregnancy
  -  history of lung transplant
  -  prison inmate
  -  inability to take oral medication or food
  -  known or suspected allergy to berries or berry products
  -  HIV patients

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

Clinical trial: Radiofrequency Ablation of Pulmonary Tumors Response Evaluation

Summary: The study hypothesis is that the radiofrequency (RF) ablation is a safe and effective treatment for malignant lung tumors.

Detailed description: Image-guided RF ablation is accepted as a viable therapeutic choice for patients with early-stage hepatocellular carcinoma or limited hepatic metastatic disease from colorectal cancer, when surgery is precluded (1, 2). Recently, RF ablation has been proposed as a viable option for the treatment of pulmonary malignancies. Experimental studies in animal tumor models have confirmed the effectiveness of RF ablation in the destruction of experimentally-induced pulmonary malignancies (3). Pilot clinical investigations have suggested that the treatment can achieve high proportions of tumor response (4, 5). We designed a prospective, intention-to-treat, multicenter clinical trial aimed at assessing feasibility, safety and effectiveness of RF ablation in the treatment of lung malignancies.

Eligibility: Inclusion Criteria:
  1. adult (> 18 years) male or female patient
  2. patient has biopsy-proven NSCLC or lung metastasis
  3. patient has been rejected for surgery and has been considered unfit for radiation therapy or chemotherapy
  4. patient has as many as 3 tumors per lung, each 3.5 cm or smaller in greatest diameter, by CT scan
  5. tumors are located at least 1 cm from trachea; main bronchi; esophagus; aorta; aortic arch branches; pulmonary artery; and heart
  6. tumors are accessible by percutaneous route
  7. patient has Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
  8. patient has platelet count > 100 x 109 /L and international normalized ratio ≤ 1.5
  9. patient has signed written informed consent prior to any study specific procedures.
  Exclusion Criteria:
  1. patient has undergone previous pneumonectomy
  2. patient is considered at high-risk for RF ablation due to major co-morbid medical conditions
  3. patient has more than 3 tumors / lung
  4. patient has at least one tumor > 3.5 in greatest diameter
  5. tumor is associated with atelectasis or obstructive pneumonitis
  6. patient has renal failure requiring hemodialysis or peritoneal dialysis
  7. patient has active clinically serious infection
  8. patient has history of organ allograft
  9. patient has history of substance abuse or any medical, psychological or social conditions that may interfere with his / her participation in the study or evaluation of the study results
  10. patient is pregnant or breast-feeding
  11. patient has ECOG performance status > 2
  12. patient has platelet count ≤ 100 x 109 /L or international normalized ratio > 1.5.

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

Clinical trial: Optical Coherence Tomography of the Airway for Lung Cancer or Lung Disease

Summary: RATIONALE: Diagnostic procedures, such as optical coherence tomography, may help find and diagnose lung cancer or precancerous cells.
  PURPOSE: This phase I trial is studying how well optical coherence tomography of the airway works in detecting abnormal cells in patients undergoing surgery for lung cancer or lung disease.

Detailed description: OBJECTIVES:
  -  Correlate optical coherence tomography images of the airway with airway histology.
  -  Develop an imaging technique to detect premalignant airway epithelial changes (carcinoma in situ, dysplasia) to study the transformation process as well as intervene and prevent the development of lung cancer.
  OUTLINE: Bronchoscopic imaging and optical coherence tomography are performed on lung tissue samples collected during surgery. All imaged areas are marked. The marked areas are then excised and fixed in formalin for histopathologic analysis.

Eligibility: DISEASE CHARACTERISTICS:
  -  Undergoing pneumonectomy or lobectomy for malignant or benign lung processes
  PATIENT CHARACTERISTICS:
  -  Not specified
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics

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

Clinical trial: Comfort Level of Two Abdominal Compression Methods Used to Hold Patients Still While Undergoing Stereotactic Body Radiation Therapy for Lung Tumors

Summary: RATIONALE: Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Abdominal compression methods that hold the body and the tumor from moving during treatment may permit radiation therapy to kill more tumor cells. This study is looking at the comfort level of two abdominal compression methods in patients with lung tumors undergoing stereotactic body radiation therapy.
  PURPOSE: This phase I trial is studying the comfort level of two abdominal compression methods used to hold patients still while undergoing stereotactic body radiation therapy for lung tumors.

Detailed description: OBJECTIVES:
  Primary
  -  To evaluate comfort associated with the existing screw-based abdominal compression device and the new automated abdominal compression device in patients with lung tumors undergoing stereotactic body radiotherapy.
  Secondary
  -  To evaluate tumor motion in patients using these devices.
  OUTLINE: This is a multicenter study.
  Patients undergo fluoroscopic assessment of tumor motion with a screw-based abdominal compression device. Patients then undergo non-contrast 4D-CT imaging with the screw-based abdominal compression device followed by contrast 4D-CT imaging with an automated abdominal compression device.
  Immediately after stereotactic body radiotherapy simulation, patients complete a questionnaire to assess the overall level of comfort of each abdominal-compression device.

Eligibility: DISEASE CHARACTERISTICS:
  -  All lung patients from the University of Texas Southwestern Medical Center, Parkland Health and Hospital System, and Richardson Regional Cancer Center scheduled to receive stereotactic body radiotherapy simulation
  -  Must have initial pre-compression lung tumor motions with respiration > 1 cm
  PATIENT CHARACTERISTICS:
  -  Negative pregnancy test
  PRIOR CONCURRENT THERAPY:
  -  Concurrent participation in other protocols allowed

Relevance to patient case: not relevant