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    Participants who either do not have cancer but are at high risk for developing the disease or have had cancer and are at high risk for developing a new cancer.
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    These trials look at ways to improve the quality of life of cancer patients, especially those who have side effects from cancer and its treatment. They find new ways to help people cope with pain, nutrition problems, infection, nausea and vomiting, sleep disorders, depression and other health problems.
  • open for enrollment

    Pazopanib Hydrochloride in Treating Patients With Progressive Carcinoid Tumors

    Protocol: ALLIANCE-A021202

    Eligibility:

    Inclusion Criteria:

    • Low- or intermediate-grade neuroendocrine carcinoma, including the following subtypes: carcinoid tumor, low- to intermediate-grade or well- to moderately-differentiated neuroendocrine carcinoma or tumor, atypical carcinoid tumor; documentation from a primary tumor or metastatic site is sufficient; patients with poorly differentiated neuroendocrine carcinoma, high-grade neuroendocrine carcinoma, adenocarcinoid tumor, or goblet cell carcinoid tumor are not eligible
    • Locally unresectable or metastatic carcinoid tumors
    • Patients must have histologic documentation or clinical evidence of a carcinoid tumor of primary site (including foregut, midgut, hindgut or other non-pancreatic site); tumors of unknown primary site are eligible provided the treating physician does not suspect medullary thyroid cancer, pancreatic neuroendocrine tumor, paraganglioma, or pheochromocytoma; unknown primary tumors will be classified as small bowel tumors for the purpose of stratification; functional (associated with a clinical syndrome) or nonfunctional tumors are allowed; target lesions must have shown disease progression if therapy included peptide receptor radiotherapy (PRRT) and PRRT must be completed at least 8 weeks prior to registration
    • Radiological evidence for progressive disease (measureable or non-measurable) within 12 months prior to registration; patients who have received anti-tumor therapy during the past 12 months (including octreotide analogs) must have had radiological documentation of progression of disease while on or after receiving therapy
    • No known endobronchial lesions and/or lesions infiltrating major pulmonary vessels that increase the risk of pulmonary hemorrhage; patients with lesions infiltrating major pulmonary vessels (contiguous tumor and vessels) are excluded; however, the presence of a tumor that is touching, but not infiltrating (abutting) the vessels is acceptable (computed tomography [CT] with contrast is strongly recommended to evaluate such lesions); patients with large protruding endobronchial lesions in the main or lobar brochi are excluded; however, endobronchial lesions in the segmented bronchi are allowed
    • Patients must have measurable disease per RECIST 1.1 by computed tomography (CT) scan or magnetic resonance imaging (MRI); lesions must be accurately measured in at least one dimension (longest diameter to be recorded) as >= 1 cm with CT or MRI (or >= 1.5 cm for lymph nodes)
    • No prior treatment with an inhibitor of vascular endothelial growth factor (VEGF) or vascular endothelial growth factor receptor (VEGFR)
    • Prior treatment (somatostatin analogs excepted) must be completed at least 4 weeks prior to registration, and any treatment-related toxicities must have improved to =< grade 1
    • Concurrent use of somatostatin analogs (SSTa) is allowed, provided that the patient is on a stable dose for at least two months and progressive disease on somatostatin analog has been documented; progression on octreotide is required for patients with tumors arising in the midgut
    • Prior treatment with embolization (including bland embolization, chemoembolization, and selective internal radiation therapy) or ablative therapies is allowed if measurable disease remains outside of the treated area or there is documented disease progression in a treated site; there is no limit on the prior number of procedures; prior liver-directed or other ablative treatment must be completed at least 8 weeks prior to registration
    • Patients should have completed any major surgery >= 4 weeks prior to registration and must have completed any minor surgery >= 2 weeks prior to registration; patients must have fully recovered from the procedure
    • The following are examples of procedures considered to be minor: port placement, laparoscopy, thoracoscopy, bronchoscopy, mediastinoscopy, skin biopsies, incisional biopsies, imaging-guided biopsy for diagnostic purposes, and dental extraction procedures
    • Insertion of a vascular access device, thoracentesis, paracentesis, and endoscopic ultrasonographic procedures are not considered to be major or minor surgeries
    • No concurrent condition resulting in immune compromise, including chronic treatment with corticosteroids or other immunosuppressive agents
    • No clinical evidence of central nervous system (CNS) metastases (including carcinomatous meningitis) at baseline, with the exception of those patients who have previously-treated CNS metastases (surgery +/- radiotherapy, radiosurgery, or gamma knife) and who meet both of the following criteria: a) are asymptomatic and b) had no requirement for steroids or enzyme-inducing anticonvulsants within 6 months prior to registration
    • No history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days prior to registration
    • No clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding within 28 days prior to registration including, but not limited to:
    • Active peptic ulcer
    • Known endoluminal metastatic lesion(s) with history of bleeding
    • Inflammatory bowel disease (e.g. ulcerative colitis, Crohn's disease), or other gastrointestinal conditions with increased risk of perforation
    • No history of serious (i.e., requiring active medical therapy with medication or medical device under the supervision of a physician) non-healing wound, ulcer, trauma, or bone fracture within 28 days prior to study entry
    • Patients with a history of hypertension must have blood pressure that is adequately controlled on antihypertensives; (< 140/90 mmHg)
    • No symptomatic congestive heart failure (New York Heart Association class II, III, or IV) within 6 months prior to registration
    • No arterial thrombotic events within 6 months of registration, including transient ischemic attack (TIA), cerebrovascular accident (CVA), peripheral arterial thrombus, unstable angina or angina requiring surgical or medical intervention in 6 months prior to registration, or myocardial infarction (MI); patients with clinically significant peripheral artery disease (i.e., claudication on less than one block) are ineligible; patients who have experienced a deep venous thrombosis or pulmonary embolus within 6 months prior to registration must be on stable therapeutic anticoagulation for at least 6 weeks prior to enrollment of this study
    • Patients on therapeutic anticoagulation with low molecular weight heparins, fondaparinux, or warfarin are eligible, provided that they are on a stable dose of anticoagulants; patients who are currently receiving antiplatelet therapy of prasugrel or clopidogrel or antiaggregation agents (e.g., eptifibatide, epoprostenol, dipyridamole) or low doses of acetylsalicylic acid (up to 100 mg daily) are also eligible
    • No ongoing cardiac dysrhythmias, atrial fibrillation, or prolongation of corrected QTc interval to > 480 msec
    • No evidence of active bleeding, bleeding diathesis, or hemoptysis (>= 1/2 teaspoon of red blood) within 8 weeks prior to registration
    • No currently unstable angina and/or uncontrolled cardiac arrhythmias
    • Patients with symptomatic peripheral vascular disease are ineligible
    • Ejection fraction on echocardiogram (Echo) or multi gated acquisition scan (MUGA) > 50%
    • Chronic concomitant treatment with strong inhibitors of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) is not allowed on this trial; patients on strong CYP3A4 inhibitors must discontinue the drug 14 days prior to the start of study treatment
    • Women must not be pregnant or nursing; women of child bearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 72 hours prior to registration; women of child-bearing potential include any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal (defined as amenorrhea >= 12 consecutive months; or women on hormone replacement therapy [HRT] with documented serum follicle stimulating hormone [FSH] level > 35 mIU/mL)
    • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
    • Granulocytes >= 1,500/mcL
    • Platelets >= 100,000/mcL
    • International normalized ratio (INR) =< 1.2 X upper limit of normal (ULN); only required for patients receiving anticoagulant therapy; patients are eligible if their INR is stable and within the recommended range for the desired level of anticoagulation
    • QTc =< 480 msecs
    • Thyroid stimulating hormone (TSH) within normal limits (WNL); medications for thyroid dysfunction are allowed as long as TSH is normal at registration
    • Bilirubin =< 1.5 x ULN
    • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) & alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x ULN; concomitant elevations in bilirubin and AST/ALT above 1.0 X ULN are NOT permitted; also, if liver metastases are present, AST & ALT =< 5 x ULN is allowed
    • Serum creatinine =< 1.5 x ULN
    • Urine protein to creatinine (UPC) ratio < 1, or, 24-hour urine protein < 1g; if UPC >= 1, then a 24-hour urine protein must be assessed; patients must have a 24-hour urine protein value < 1 g to be eligible; use of urine dipstick for renal function assessment is not acceptable

    Principal Investigator: Manisha H Shah, MD

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  • open for enrollment

    Surgery With or Without Docetaxel and Leuprolide or Goserelin in Treating Patients With High-Risk Localized Prostate Cancer

    Protocol: CALGB-90203

    Eligibility:

    1. Histologic documentation - Histologic documentation of prostatic adenocarcinoma.

    Patients with small cell, neuroendocrine, or transitional cell carcinomas are not eligible.

    All eligible patients must have a known Gleason sum based on biopsy or TURP at the time of registration.

    2. Clinically localized disease - Patients must have clinical stage T1-T3a and no radiographic evidence of metastatic disease as demonstrated by:

    • EITHER CT or MRI of the abdomen and pelvis, OR endorectal MRI of the pelvis that demonstrate no nodes > 1.5 cm. If one or more pelvic lymph node(s) measures > 1.5 cm, a negative biopsy is required. If more than one lymph node is > 1.5 cm, the largest or most accessible node should be biopsied.

    AND

    • Negative bone scan (with plain films and/or MRI and/or CT scan confirmation, if necessary). Positive PET and Prostascint scans are not considered proof of metastatic disease.

    3. Determination of high-risk status: Patients must have either:

    • A Kattan nomogram predicted probability of being free from biochemical progression at 5 years after surgery of < 60%.

    OR

    • Prostate biopsy Gleason sum = 8 (NOTE: The Kattan nomogram probability must be calculated for all patients, including those eligible based on Gleason sum = 8 only.)

    4. Prior treatment - No prior treatment for prostate cancer including prior surgery (excluding TURP), pelvic lymph node dissection, radiation therapy, or chemotherapy.

    Patients may have received up to 4 months of androgen deprivation therapy (LHRH agonists, antiandrogens, or both) prior to being enrolled on the study.

    5. Appropriate surgical candidates - Patients must be appropriate candidates for radical prostatectomy with an estimated life expectancy > 10 years as determined by a urologist. Evidence of underlying cardiac disease should be evaluated prior to enrollment to ensure that patients are not at high risk of cardiac complications.

    6. Clotting history - Patients with a history of deep venous thrombosis, pulmonary embolism, and/or cerebrovascular accident or currently requiring systemic anticoagulation are eligible provided they are determined to be candidates for radical prostatectomy.

    7. ECOG performance status: 0-2

    8. Age: = 18 years of age

    9. Required Initial Laboratory Values:

    • ANC = 1500/µL
    • Platelet count = 150,000/µL
    • Creatinine = 2.0 mg/dL
    • Pre-registration serum PSA level = 100 ng/mL
    • Bilirubin = 1.5XULN (2.5XULN in patients with Gilbert's disease)
    • AST/ALT =1.5XULN
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  • open for enrollment

    MRI in Diagnosing Solid Tumors of the Eye and Orbit

    Protocol: OSU-0361

    Eligibility:

    Inclusion Criteria:

    • The patient has an orbital mass which needs further diagnostic evaluation before treatment or for monitoring
    • Able to give informed consent
    • Return for follow-up visits

    Exclusion Criteria:

    • Patients with a lesion < 2 mm
    • The patient should not participate in this study is any of the following applies to the patient: the patients has a pacemaker, metallic cardiac valve(s), magnetic material such as surgical clips, implanted electronic infusion pumps or any other condition that would interfere with the MRI, the patient has a stent somewhere in the body, the patient has a history of allergic reaction to any metals, contrast agents, x-ray dyes, the patient has claustrophobia
    • Patients cannot be pregnant and prisoners will not be considered for the study
    • Exposure to gadolinium-based contrast agents increases the risk for nephrogenic systemic fibrosis (NSF) in patients with acute or severe renal dysfunction; therefore, patients with the following conditions are excluded from the study:
    • Acute or chronic severe renal insufficiency (glomerular filtration rate < 30 mL/min/1.73 m^2)
    • Acute renal dysfunction due to the hepato-renal syndrome or in the perioperative liver transplantation period
    • In order to identify subjects at risk for the development of NSF, the American College of Radiology (http://acr.org) recommends obtaining a medical history and a glomerular filtration rate (GFR) assessment within six weeks of MR imaging in the following patients:
    • Renal disease (including solitary kidney, renal transplant, renal tumor)
    • Age > 60
    • History of hypertension
    • History of diabetes
    • History of severe hepatic disease/liver transplant/pending liver transplant
    • All subjects providing written informed consent will complete the subject history and screening form prior to MR imaging; the form will be reviewed to determine whether the subject is at risk as defined above and the availability of an estimated glomerular filtration rate (eGFR) within six weeks of anticipated MR imaging; an eGFR result greater than six weeks prior to the MRI imaging date will be repeated and evaluated for renal function; subjects with an eGFR of < 30 mL/min/1.73 m^2 will be excluded from the study

    Principal Investigator: Michael V Knopp, MD, PhD

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  • open for enrollment

    Transoral Robotic Surgery in Treating Patients With Benign or Malignant Tumors of the Head and Neck

    Protocol: OSU-07061

    Eligibility:

    Inclusion Criteria:

    • Patient must present with indications for diagnostic or therapeutic approaches for benign and/or malignant diseases of the oral cavity or laryngopharynx (including the neoplastic lesions of the tongue, tongue base, retromolar trigone, tonsils, palate, posterior and lateral pharynx, glottic, supraglottic and subglottic larynx)
    • Patients must have adequate transoral exposure of the oral cavity and laryngopharynx for TORS instrumentation
    • Written informed consent and/or Consent waiver by institutional review board (IRB)

    Exclusion Criteria:

    • Unexplained fever and/or untreated, active infection
    • Patient pregnancy
    • Previous head and neck surgery precluding transoral/robotic procedures
    • The presence of medical conditions contraindicating general anesthesia or transoral surgical approaches
    • Inability to grant informed consent
    • INTRAOPERATIVE EXCLUSION CRITERIA:
    • Inability to adequately visualize anatomy to perform the diagnostic or therapeutic surgical approach transorally
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  • open for enrollment

    3 Tesla MRI in Patients With Bladder Cancer

    Protocol: OSU-08063

    Eligibility:

    Inclusion Criteria:

    • Known bladder cancer
    • Scheduled for radical cystectomy and lymph node dissection.
    • Able and willing to give valid written informed consent.
    • No contraindications to the MRI(magnetic resonance imaging).

    Exclusion Criteria:

    • Not pregnant, planning to become pregnant during the study, or nursing.
    • No allergy to contrast agents.
    • Patient with significant renal insufficiency, i.e. an estimated glomerular filtration rate(eGRF) less than 30 mL/min/1.73m2.
    • Any condition conflict based on the investigation's clinical judgment that would prevent the patient from completion all trial assessments and visits.
    • Inability or unwillingness to cooperate with requirements of this trial.
    • Patients who exhibit noticeable anxiety and/or claustrophobia or who exhibit severe vertigo when they are moved into the MR.
    • Patients with sickle cell anemia and other hemolytic anemia.

    Principal Investigator: Michael V Knopp, MD, PhD

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  • open for enrollment

    Selinexor and Chemotherapy in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia

    Protocol: OSU-14089

    Eligibility:

    Inclusion Criteria:

    • Patients with relapsed or refractory AML; Cohort A patients must be < 65 years of age; Cohort B patients must be > 60 years of age, unfit for intensive therapy (physician opinion), and have failed at least one salvage regimen for relapsed/refractory AML; the maximum number of prior lines of induction for both cohorts is 3
    • Patients with secondary AML or therapy related disease (t-AML) are eligible
    • If the patient has co-morbid medical illness, life expectancy attributed to this must be greater than 6 months
    • Eastern Cooperative Oncology Group (ECOG) performance status =< 2
    • Total bilirubin < 2.0 mg/dL
    • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) < 2.5 X institutional upper limit of normal
    • Creatinine (Cr) clearance > 50 mL/min by Modification of Diet in Renal Disease (MDRD) calculation
    • New York Heart Association (NYHA) congestive heart failure (CHF) class II or better
    • Cardiac ejection fraction >= 50%
    • Female patients of child-bearing potential must agree to use dual methods of contraception and have a negative serum pregnancy test at screening, and male patients must use an effective barrier method of contraception if sexually active with a female of child-bearing potential; acceptable methods of contraception are condoms with contraceptive foam, oral, implantable or injectable contraceptives, contraceptive patch, intrauterine device, diaphragm with spermicidal gel, or a sexual partner who is surgically sterilized or post-menopausal; for both male and female patients, effective methods of contraception must be used throughout the study and for three months following the last dose
    • Ability to understand and willingness to sign the written informed consent document

    Exclusion Criteria:

    • Patients who have had chemotherapy or radiotherapy within 2 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study
    • Patients receiving any other investigational agents or patients that have received other investigational agents within 14 days of enrollment
    • Patients with active central nervous system (CNS) malignancy; asymptomatic small lesions are not considered active; treated lesions may be considered inactive if they are stable for at least 3 months; patients with malignant cells in their cerebrospinal fluid (CSF) without CNS symptoms may be included
    • Major surgery within 2 weeks before day 1
    • Uncontrolled active infection; patients with infection requiring parenteral antibiotics are eligible if the infection is controlled
    • Patients with significantly diseased or obstructed gastrointestinal tract or uncontrolled vomiting or diarrhea
    • History of seizures, movement disorders or cerebrovascular accident within the past 3 years prior to cycle 1 day 1
    • Patients with macular degeneration, uncontrolled glaucoma, or markedly decreased visual acuity
    • Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure (New York Heart Association [NYHA) class III or IV), unstable angina pectoris, myocardial infarction within 6 months prior to enrollment, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities; prior to study entry, any electrocardiogram (ECG) abnormality at screening has to be documented by the investigator as not medically relevant
    • Patients with serious medical or psychiatric illness likely to interfere with participation in this clinical study
    • Pregnant women or women who are breastfeeding are excluded from this study; confirmation that the subject is not pregnant must be established by a negative serum beta (ß)-human chorionic gonadotropin (ß-hCG) pregnancy test result obtained during screening; pregnancy testing is not required for post-menopausal or surgically sterilized women
    • Patients with advanced malignant solid tumors
    • Patients whom, in the opinion of the investigators, are significantly below their ideal body weight
    • Patients who are not able to swallow capsules or tablets
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  • open for enrollment

    3-Tesla MRI in Finding Tumors in Patients With Known or Suspected Prostate Cancer

    Protocol: OSU-07042

    Eligibility:

    Inclusion Criteria:

    • Patients with known or suspected prostate disease based on clinical data will be included in the study; patients with intermediate to high grade prostate cancer (Gleason's score >= 7 and prostate-specific antigen [PSA] of > 10ng/dl) will be referred from the outpatient clinics after evaluation by the treating physicians
    • Written informed consent will be signed by the patients before the MRI based on the guidelines approved by the Ohio State University Institutional Review board
    • Patients must have an estimated glomerular filtration rate of >= 30 mL/min/1.73m^2 within six weeks of the MRI to be included in the study

    Exclusion Criteria:

    • Patients with any type of bioimplant activated by mechanical, electronic, or magnetic means (e.g., cochlear implants, pacemakers, neurostimulators, biostimulators, electronic infusion pumps, etc.)
    • Patients with any type of ferromagnetic bioimplant that could potentially be displaced or damaged
    • Patients that have vascular or aneurysm clips, or metallic staples from a surgical procedure
    • Patients with permanent tattoo eye liner (may contain metallic coloring)
    • Patients that may have shrapnel imbedded in their bodies, such as from war wounds, metal workers and machinists (metallic fragments in or near eyes), severe auto accident victims
    • Patients that exhibit noticeable anxiety and/or claustrophobia
    • Patients who cannot adhere to the experimental protocols for any reason, or have an inability to communicate with the researcher
    • Patients who have cardiac or known circulatory impairment, and/or the inability to perspire (poor thermoregulatory function)
    • Patients with an estimated glomerular filtration rate of < 30 mL/min/1.73m^2 within six weeks of the MRI
    • Acute or chronic severe renal insufficiency (estimated glomerular filtration rate < 30 mL/min/1.73m^2)
    • Acute renal dysfunction due to the hepato-renal syndrome or in the perioperative liver transplantation period

    Principal Investigator: Michael V Knopp, MD, PhD

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  • open for enrollment

    A Phase 3 Study to Evaluate Efficacy and Safety of Masitinib in Comparison to Imatinib in Patients With Gastro-Intestinal Stromal Tumour in First Line Medical Treatment

    Protocol: OSU-08078

    Eligibility:

    Inclusion Criteria:

    1. Histologically proven, metastatic or locally advanced non resectable, or recurrent post surgery GIST

    2. Naïve patient or patient previously treated with imatinib as neoadjuvant/adjuvant who relapsed after imatinib discontinuation

    3. C-Kit (CD117) positive tumours detected immuno-histochemically or PDGF positive if c-kit negative

    4. Man or woman, age >18 years

    5. Man and woman of childbearing potential, (entering the study after a menstrual period and who have a negative pregnancy test) must agree to use two methods (one for the patient and one for the partner) of medically acceptable forms of contraception during the study and for 3 months after the last treatment intake

    6. Patient able and willing to comply with study procedures as per protocol

    7. Patient able to understand, sign, and date the written voluntary informed consent form at screening visit prior to any protocol-specific procedures

    Exclusion Criteria:

    1. Patient previously treated by tyrosine kinase inhibitors except imatinib in case of inclusion criteria 2

    2. Patient treated for a cancer other than GIST within 5 years before enrolment, with the exception of basal cell carcinoma or cervical cancer in situ

    3. Patient with active central nervous system (CNS) metastasis or with history of CNS metastasis

    4. Patient with grade III/IV cardiac problems as defined by the New York Heart Association Criteria. (i.e. congestive heart failure, myocardial infarction within 6 months before baseline) Patient with any condition that the physician judges could be detrimental to subjects participating in this study; including any clinically important deviations from normal clinical laboratory values or concurrent medical events Previous treatment

    5. Treatment with any investigational agent within 4 weeks prior baseline

    6. Treatment by imatinib as neoadjuvant/adjuvant therapy within 4 weeks prior baseline

    Principal Investigator: Tanios Bekaii-Saab, MD

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  • open for enrollment

    Hypofractionated Boost Before Chemoradiation for Patients With Stage II-III Non-small Cell Lung Cancer Unsuitable for Surgery

    Protocol: OSU-14091

    Eligibility:

    Inclusion Criteria:

    • All prior treatment-related toxicities must be Common Terminology Criteria for Adverse Events (CTCAE) (version 4.0) =< grade 1 (except alopecia) at the time of enrollment
    • Absolute neutrophil count >= 1.5 x 10^9/L
    • Hemoglobin >= 9 g/dL
    • Platelets >= 100 x 10^9/L
    • Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.5; unless using warfarin for therapeutic anti-coagulation
    • Albumin >= 2.5 g/dL
    • Total bilirubin =< 1.5 x upper limit of normal (ULN)
    • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x ULN
    • Creatinine =< 1.5 ULN AND
    • Calculated creatinine clearance >= 50 mL/min (calculated by the Cockcroft-Gault formula) or
    • 24-hour urine creatinine clearance >= 50 mL/min
    • Non-small cell lung cancer (NSCLC), histologically and/or cytologically proven
    • Clinical American Joint Committee on Cancer (AJCC) stage (7th edition) IIA-IIIB NSCLC (T1-4N1-3M0)
    • Patients must be considered unresectable or medically-inoperable
    • Non-bulky lymphadenopathy =< 3 cm as defined by computed tomography (CT) largest axial diameter
    • Patients must have primary tumor =< 6 cm as defined by CT largest axial dimension
    • Within 4 weeks of registration: patients must have CT chest with IV contrast, fludeoxyglucose F 18 (FDG)-positron emission tomography (PET)-CT scan (or CT abdomen/pelvis), and magnetic resonance imaging (MRI) brain with IV contrast (or CT head with contrast if contraindications to MRI); a non-contrast MRI chest or brain is permitted if patient has allergy to CT contrast or renal insufficiency
    • Within 8 weeks of registration: pulmonary function tests (PFTs) including forced expiratory volume in one second (FEV-1) and diffusing capacity of the lung for carbon monoxide (DLCO)
    • Within 2 weeks of registration: patients must have vital signs, history/physical examination, laboratory studies (complete blood count panel [CBCP] with differential, chemistries including liver function tests, creatinine clearance [CrCl] assessment, pregnancy test if needed)
    • If a pleural effusion is present and visible on both CT scan AND chest x-ray, the investigator should exclude malignant disease by pleurocentesis to confirm cytologically-negative pleural fluid; if fluid is exudative or cytologically positive for tumor cells, patient is excluded
    • Life expectancy of at least 12 weeks in the opinion of investigator
    • Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
    • Patients must be a minimum of 3 weeks from thoracotomy (if performed) and well-healed before starting treatment
    • Ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed
    • Women of child-bearing potential (WOCBP) must have a negative pregnancy test within 14 days of the first administration of study treatment; urine human gonadotropin (HCG) is an acceptable pregnancy assessment
    • Nursing women may participate only if nursing is discontinued
    • Women/men of reproductive potential must be counseled on contraception/abstinence while receiving the study treatment

    Exclusion Criteria:

    • Patients with contralateral hilar involvement (greater than 1.5 cm on short axis or positive on PET scan, or biopsy-proven)
    • Documented or pathologically-proven metastatic disease
    • Presence of nodules considered neoplastic in the same lobe as the primary tumor (stage T3), unless the nodule can be encompassed in the stereotactic boost (gross tumor volume [GTV]boost) without exceeding a total GTVboost size of 6 cm as defined by CT largest axial dimension
    • Presence of nodules considered neoplastic in other ipsilateral lobes (stage T4) or contralateral lobes (M1a)
    • Patients with history of pneumonectomy
    • Prior cytotoxic chemotherapy or molecularly-targeted agents (e.g. erlotinib, crizotinib), unless > 2 years prior
    • Any concurrent malignancy other than non-melanoma skin cancer, non-invasive bladder cancer, or carcinoma in situ of the cervix; patients with a previous malignancy without evidence of disease for >= 3 years will be allowed to enter the trial
    • History of active connective tissue disease (scleroderma) or idiopathic pulmonary fibrosis
    • History of previous radiation therapy to the chest which would result in overlapping fields
    • History of allergic reaction to cisplatin or etoposide
    • Uncontrolled neuropathy grade 2 or greater, regardless of cause
    • Subjects who are breast-feeding, or have a positive pregnancy test will be excluded from the study; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
    • Significant pre-existing hearing loss, as defined by the patient or treating physician
    • Any serious and/or unstable pre-existing medical disorder (aside from malignancy exception above), psychiatric disorder, or other conditions that could interfere with subject's safety, obtaining informed consent or compliance to the study procedures, in the opinion of the Investigator; this could include severe, active co-morbidities such as:
    • Uncontrolled cardiac disease (hypertension, unstable angina, myocardial infarction within last 6 months, uncontrolled congestive heart failure, cardiomyopathy with decreased ejection fraction)
    • Acute bacterial or fungal infection requiring intravenous antibiotics at time of registration
    • Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days of registration
    • Hepatic insufficiency resulting in jaundice and/or coagulation defects

    Principal Investigator: Terence M Williams, MD, PhD

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