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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

    Individualized Treatment in Treating Patients with Stage II-IVB Nasopharyngeal Cancer Based on EBV DNA

    Protocol: NRG-HN001

    Eligibility:

    Inclusion Criteria:

    Biopsy proven (from primary lesion and/or lymph nodes) diagnosis of cancer of the nasopharynx

    Patients must have detectable pretreatment plasma EBV DNA, determined by the central lab prior to Step 2 registration

    Stage II-IVB disease (American Joint Committee on Cancer [AJCC], 7th edition [ed.]) with no evidence of distant metastasis, based upon the following minimum diagnostic workup:

    History/physical examination by a Medical Oncologist or Clinical Oncologist or Radiation Oncologist or Ear, Nose, Throat specialist (ENT), which must include an endoscopic evaluation, a complete list of current medications, and assessment of weight and weight loss in the past 6 months within 21 days prior to registration

    Evaluation of tumor extent with magnetic resonance imaging (MRI) of the nasopharynx and neck within 28 days prior to registration; if MRI is medically contraindicated, obtain computed tomography (CT) scan with =< 3 mm contiguous slices with contrast and bone windows (to evaluate base of skull involvement); Note: If a treatment planning CT scan is used, it must be with =< 3 mm contiguous slices with contrast and be read by a radiologist

    To rule out distant metastasis, patients must undergo the following imaging within 28 days prior to registration:

    • A CT scan with contrast of the chest, abdomen, and/or pelvis or a total body positron emission tomography (PET)/CT scan (non-contrast PET/CT is acceptable)
    • A bone scan only when there is suspicion of bone metastases (a PET/CT scan can substitute for the bone scan)

    Zubrod performance status 0-1 within 21 days prior to registration

    Absolute neutrophil count (ANC) >= 1,500 cells/mm^3

    Platelets >= 100,000 cells/mm^3

    Hemoglobin >= 8.0 g/dl (Note: the use of transfusion or other intervention to achieve hemoglobin [Hgb] >= 8.0 g/dl is acceptable)

    Total bilirubin =< 1.5 x institutional upper limit of normal (ULN)

    Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =< 1.5 x institutional ULN

    Alkaline phosphatase =< 1.5 x institutional ULN

    Serum creatinine =< 1.5 mg/dl or calculated creatinine clearance (CC) >= 50 ml/min determined by 24-hour urine collection or estimated by Cockcroft-Gault formula

    Negative serum pregnancy test within 14 days prior to registration for women of childbearing potential

    Women of childbearing potential and male participants who are sexually active must agree to use a medically effective means of birth control throughout protocol treatment

    Patient must provide study specific informed consent prior to study entry, including the mandatory pre-treatment plasma EBV DNA assay

    Exclusion Criteria:

    Prior invasive malignancy (except node negative, non-melanomatous skin cancer) unless disease free for a minimum of 1095 days (3 years) (for example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible)

    Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable; however, at least 6-weeks recovery is necessary if the last regimen included nitrosourea or mitomycin

    Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields

    Patients with hearing loss assessed to be primarily sensorineural in nature, requiring a hearing aid, or intervention (i.e. interfering in a clinically significant way with activities of daily living); a conductive hearing loss from tumor-related otitis media is allowed

    >= Grade 2 peripheral sensory neuropathy (CTCAE, v. 4.0)

    Severe, active co-morbidity, defined as follows:

    Major medical or psychiatric illness, which in the investigator’s opinion would interfere with the completion of therapy and follow up or with full understanding of the risks and potential complications of the therapy

    Unstable angina and/or uncontrolled congestive heart failure

    Myocardial infarction within the last 6 months

    Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration; note that patients switched from IV antibiotics and currently on oral antibiotics whose infection is assessed to be adequately treated or controlled are eligible

    Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days prior to registration

    Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; note, however, that human immunodeficiency virus (HIV) testing is not required for entry into this protocol

    Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception

    Prior allergic reaction to the study drug(s) involved in this protocol

    Patients with undetectable pre-treatment plasma EBV DNA

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  • open for enrollment

    Intensity Modulated Accelerated Partial Breast Irradiation in Treating Older Patients with Hormone Responsive Stage 0-I Breast Cancer before Surgery

    Protocol: OSU-13282

    Eligibility:

    Inclusion Criteria:

    COHORT I:

    The patient must consent to be in the study and must have signed an approved consent form conforming with federal and institutional guidelines

    Patient must be > 18 years

    The patient must have clinical node negative, stage I breast cancer

    The surgical treatment must be intended to be a lumpectomy

    The biopsy site must have been demarcated by a clip(s)

    Gross disease must be unifocal on mammogram (mammo)/magnetic resonance imaging (MRI) imaging

    Patient must be able to tolerate lying in the prone position with arms extended forward

    Must be able to tolerate MRI scan with contrast

    COHORT II: The patient must consent to be in the study and must have signed an approved consent form conforming with federal and institutional guidelines

    COHORT II: Patient must be >= 60 years

    COHORT II: Core biopsy demonstrating breast cancer and receptors that are estrogen receptor (ER) or progesterone receptor (PR) positive

    COHORT II: Core tissue must have human epidermal growth factor receptor 2 (HER 2) testing

    COHORT II: The patient must have clinical node negative, stage I breast cancer

    COHORT II: The surgical treatment must be intended to be a lumpectomy

    COHORT II: The biopsy site must have been demarcated by a clip(s)

    COHORT II: Gross disease must be unifocal on Mammo/ MRI imaging

    COHORT II: Patients must have estrogen receptor (ER) and progesterone receptor (PR) analysis performed on core biopsy

    COHORT II: Patient must be able to tolerate lying in the prone position with arms extended forward

    COHORT II: Must be able to tolerate MRI scan with contrast

    COHORT II: At the time of enrollment, patients must have had bilateral mammograms within 6 months

    COHORT II: Patients must be willing to undergo breast cancer surgery minimally 4, maximally 6 weeks post APBI

    COHORT II: Patients with a history of non-breast malignancies are eligible if they have been disease free for 5 or more years prior to enrollment and are deemed by their physicians to be at low risk for recurrence; patients with the following cancers are eligible if diagnosed and treated within the past 5 years: carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, and basal cell and squamous cell carcinoma of the skin

    Exclusion Criteria:

    COHORT II:

    Age < 60 years

    Hormone unresponsive breast cancer

    T-2 (> 3.0 cm), T-3, stage III, or stage IV breast cancer

    N-1, N-2, or N-3 pathologic axillary nodes

    Mastectomy intended

    Unwilling to undergo anti-endocrine therapy

    Suspicious microcalcification, densities, or palpable abnormalities (in the ipsilateral or contralateral breast) unless biopsied and found to be benign

    Non-epithelial breast malignancies such as sarcoma or lymphoma

    Paget’s disease of the nipple

    Proven multicentric carcinoma (invasive or ductal carcinoma in situ [DCIS]) in more than one quadrant or separated by > 4 centimeters

    Any prior treatment with radiation therapy, chemotherapy, biotherapy, or hormone therapy for the currently diagnosed breast cancer prior to study enrollment

    Prior breast or thoracic radiation therapy (RT) for any condition

    Psychiatric of addictive disorders or other condition that in the opinion of the investigator would preclude the patient from meeting the study requirements

    Principal Investigator: Julia White, MD

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  • open for enrollment

    Chemotherapy and Pelvic Radiation Therapy with or without Additional Chemotherapy in Treating Patients with High-Risk Early-Stage Cervical Cancer after Radical Hysterectomy

    Protocol: RTOG-0724

    Eligibility:

    Inclusion Criteria:

    Patients must have undergone radical hysterectomy (open, laparoscopically or robotic) and staging including pelvic node sampling or dissection for cervical carcinoma within 70 days prior to study entry (NOTE: if the patient did not have a para-aortic lymph node sampling/dissection, but had common iliac node dissection that was negative, a positron emission tomography [PET]-computed tomography [CT] is recommended, but not required; a negative pre or post-operative PET scan or PET-CT scan of the para–aortic nodes is required if the patient did not undergo para-aortic or common iliac nodal sampling/dissection)

    Patients with clinical stage IA2, IB or IIA squamous, adenosquamous, or adenocarcinoma of the cervix who have any/all of the following high-risk features after surgery:

    Positive pelvic nodes

    Positive parametrium

    Positive para-aortic nodes- completely resected, PET/CT negative (PET only required if positive para-aortic nodes during surgery)

    No distant metastases, based upon the following minimum diagnostic workup (NOTE: patients with positive para-aortic nodes- completely resected, PET/CT negative are eligible):

    History/physical examination within 56 days prior to study entry

    Contrast-enhanced imaging of the abdomen and pelvis by either CT, magnetic resonance imaging (MRI), or whole body PET-CT (with or without contrast) within 90 days prior to registration (NOTE: whole body PET-CT is preferred)

    Chest x-ray (posterioranterior [PA] and lateral) or chest CT within 70 days prior to study entry (except for those who have had whole body PET-CT)

    Zubrod performance status 0-1

    Absolute neutrophil count (ANC) >= 1,800 cells/mm^3

    Platelets >= 100,000 cells/mm^3

    Hemoglobin >= 10.0 g/dl (Note: the use of transfusion or other intervention to achieve hemoglobin [Hgb] >= 10.0 g/dl is acceptable)

    White blood cell count >= 4000 cells/mm^3

    Serum creatinine =< 1.5 mg/dL within 14 days prior to study entry

    Bilirubin =< 1.5 times normal 14 days prior to study entry

    Alkaline phosphatase within upper limits of institutional normal within 14 days prior to study entry

    Alanine aminotransferase (ALT)/serum glutamate pyruvate transaminase (SGPT) and/or aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT) within upper limits of institutional normal within 14 days prior to study entry

    Patients with known human immunodeficiency virus (HIV) positive must have a cluster of differentiation (CD)4 cell count be >= 350 cells/mm^3 within 14 days prior to study entry (note, however, that HIV testing is not required for entry into this protocol)

    Patient must provide study-specific informed consent prior to study entry

    Exclusion Criteria:

    Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years (for example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible)

    Patients can not have any neuroendocrine histology in pathology

    Prior systemic chemotherapy for the current cervical cancer; note that prior chemotherapy for a different cancer is allowable

    Prior radiation therapy to the pelvis that would result in overlap of radiation therapy fields

    Severe, active co-morbidity, defined as follows:

    Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months

    Transmural myocardial infarction within the last 6 months

    Acute bacterial or fungal infection requiring intravenous antibiotics at the time of study entry

    Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of study entry

    Coagulation defects; note, however, that coagulation parameters are not required for entry into this protocol

    Prior allergic reaction to carboplatin, paclitaxel, and/or cisplatin

    Patients who have gross residual disease or distant metastatic disease

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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; for the non-surgical arm: Patients planned to receive non-surgical treatment (e.g., chemo and/or radiation); the 7 surgical (TORS) arms include: tonsil cancer: T1, tonsil cancer: T2, base of tongue cancer: T1, base of tongue cancer: T2, supraglottic cancer, unknown primary cancer, and other tumors; the 3 non-surgical arms are: tonsil cancer, base of tongue cancer, and supraglottic/hypopharyngeal/other cancers

    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 that would preclude transoral/robotic procedures; this is at the investigator’s discretion; this is not an exclusion criterion for the non-surgical arm

    The presence of medical conditions contraindicating general anesthesia or transoral surgical approaches; this is not an exclusion criterion for the non-surgical arm

    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

    Paclitaxel and Carboplatin with or without Metformin Hydrochloride in Treating Patients with Stage III, IV, or Recurrent Endometrial Cancer

    Protocol: GOG-0286B

    Eligibility:

    Inclusion Criteria:

    Patients must have measurable stage III, measurable stage IVA, stage IVB (with or without measurable disease) or recurrent (with or without measurable disease) endometrial carcinoma

    Histologic confirmation of the original primary tumor is required; patients with the following histologic epithelial cell types are eligible:

    • Endometrioid adenocarcinoma, serous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, adenocarcinoma not otherwise specified (N.O.S.)

    Measurable disease is defined by Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1); measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded); each lesion must be >= 10 mm when measured by computed tomography (CT), magnetic resonance imaging (MRI) or caliper measurement by clinical exam; or >= 20 mm when measured by chest x-ray; lymph nodes must be >= 15 mm in short axis when measured by CT or MRI

    Patients must have a Gynecologic Oncology Group (GOG) performance status of 0, 1, or 2

    Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl

    Platelets greater than or equal to 100,000/mcl

    Creatinine less than 1.4 mg/dl

    Bilirubin less than or equal to 1.5 x institutional/laboratory upper limit of normal (ULN)

    Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to 3 x ULN

    Alkaline phosphatase less than or equal to 2.5 x ULN

    Patients must NOT have received prior chemotherapy or targeted therapy, including chemotherapy used for radiation sensitization for treatment of endometrial carcinoma

    Patients may have received prior radiation therapy for treatment of endometrial carcinoma; prior radiation therapy may have included pelvic radiation therapy, extended field pelvic/para-aortic radiation therapy, and/or intravaginal brachytherapy; all radiation therapy must be completed at least 4 weeks prior to the first date of study therapy

    Patients may have received prior hormonal therapy for treatment of endometrial carcinoma; all hormonal therapy must be discontinued at least one week prior to the first date of study therapy

    Patients must be able to swallow and retain orally-administered medication

    Patients must have signed an approved informed consent and authorization permitting release of personal health information; individuals with impaired decision-making capacity are not eligible to participate on the study

    Exclusion Criteria:

    Patients must NOT be taking metformin or have been on metformin in the past 6 months

    Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer are excluded if there is any evidence of other malignancy being present within the last three years

    Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

    Patients who are pregnant or nursing; if patients are of reproductive age and have not undergone hysterectomy, they must use an effective contraceptive method for the duration of this study

    Any condition associated with increased risk of metformin-associated lactic acidosis; (e.g. congestive heart failure defined as New York Heart Association [NYHA] class III or IV functional status, history of acidosis of any type; habitual intake of 3 or more alcoholic beverages per day)

    Principal Investigator: David M O'Malley, MD

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  • open for enrollment

    Ph III, Nivolumab w/Ipilimumab vs SOC Chemotherapy w/ Untreated/ Unresectable or Metastatic Urothe

    Protocol: OSU-17139

    Principal Investigator: Amir Mortazavi, MD

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  • open for enrollment

    The KETO-CARE Study

    Protocol: OSU-16289

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