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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

    Whole-Brain Radiation Therapy with or without Hippocampal Avoidance in Treating Patients with Limited Stage or Extensive Stage Small Cell Lung Cancer

    Protocol: NRG-CC003

    Eligibility:

    Inclusion Criteria:

    PRIOR TO STEP 1 REGISTRATION

    Histologic proof or unequivocal cytologic proof (fine needle aspiration, biopsy or two positive sputa) of SCLC within 250 days prior to Step 1 registration

    Patients must be registered on study no earlier than 7 days and no later than 56 days prior to Step 1 registration after completing chemotherapy (+/- thoracic radiotherapy)

    Patients must have a three-dimensional (3D), T1-weighted, spoiled gradient (SPGR), magnetization-prepared rapid gradient echo (MP-RAGE), or turbo field echo (TFE) MRI scan without and with gadolinium contrast-enhanced T1-weighted axial, coronal, and sagittal sequence acquisitions and standard T2-weighted axial and coronal fluid attenuation inversion recovery (FLAIR) sequence acquisitions within 28 days of Step 1 registration; to yield acceptable image quality, the pre-contrast-enhanced should have a resolution of 1 x 1 x 1.2 mm and should follow the protocols established by the Alzheimer’s Disease Neuroimaging Initiative (ADNI); performance of this sequence at a 3 Tesla field strength is recommended; sites may contact the Imaging Co-Chair, Dr. Tammie Benzinger, for further information or assistance if needed; to yield acceptable image quality, the gadolinium contrast-enhanced T1-weighted scan should use the smallest possible axial slice thickness not exceeding 1.5 mm; the associated coronal and sagittal sequences can be up to 2.5 mm in slice thickness; this imaging is considered standard of care

    Note: the MRI study is mandatory irrespective of randomization to the experimental or control arm of this study

    Prior to chemotherapy +/- or thoracic radiotherapy, patients must be defined as limited-stage or extensive-stage SCLC after clinical staging evaluation involving the following:

    History/physical examination;

    Computed tomography (CT) of the chest and abdomen with contrast (does not have to be done if the patient has had a positron emission tomography (PET)/CT scan prior to initiating chemotherapy or thoracic radiotherapy)

    MRI of the brain prior to initiating chemotherapy or thoracic radiotherapy

    For patients without evidence of extensive-stage SCLC on chest and abdomen CT and brain MRI, a PET/CT or bone scan is required to confirm limited-stage SCLC

    After chemotherapy, patients must be restaged within 56 days prior Step 1 registration using the same diagnostic work-up as required pre-chemotherapy; repeat PET/CT or bone scan is not required; patients must have:

    History/physical examination

    No central nervous system (CNS) metastases (repeat MRI required)

    Radiographic partial or complete response to chemotherapy in at least one disease site using Response Evaluation Criteria in Solid Tumors (RECIST) criteria

    No progression in any site

    Zubrod performance status 0-2 within 30 days prior to Step 1 registration

    Women of childbearing potential must have a negative qualitative serum pregnancy test =< 14 days prior to Step 1 registration

    Patients who are primary English or French speakers are eligible

    Patients must sign a study-specific informed consent prior to study entry

    PRIOR TO STEP 2 REGISTRATION

    The following baseline neurocognitive assessments must be completed and uploaded within 10 calendar days after Step 1 registration: HVLT-R, TMT, and COWA; the neurocognitive assessments will be uploaded into the National Surgical Adjuvant Breast and Bowel Project, Radiation Therapy Oncology Group, and Gynecologic Oncology Group (NRG) Oncology RAVE system for evaluation by Dr. Wefel; once the upload is complete, a notification will be sent to the site to proceed to Step 2; note: completed baseline neurocognitive assessments can be uploaded at the time of Step 1 registration

    Patients must have a baseline raw score greater than 2 on the HVLT-R delayed recall be determined by the Neurocognitive Co-Chair, Dr. Wefel

    Exclusion Criteria:

    Prior radiotherapy to the head or neck (except for T1 glottic cancer), resulting in overlap of radiation fields

    Radiographic evidence of CNS metastases

    Radiographic evidence of hydrocephalus

    Planned concurrent chemotherapy or anti-tumor agent during PCI

    Concomitant invasive malignancy or invasive malignancy within the past five years other than non-melanomatous skin cancer; history of in situ carcinoma (e.g. ductal carcinoma in situ of breast, in situ carcinoma of the cervix, vulva or larynx) is permitted

    Contraindication to MR imaging, such as implanted metal devices or foreign bodies or severe claustrophobia

    Severe, active comorbidity, 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 registration

    Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects

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

    Uncontrolled, clinically significant cardiac arrhythmias

    Human immunodeficiency virus (HIV) positive with cluster of differentiation (CD)4 count < 200 cells/microliter

    • Note: patients who are HIV positive are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count >= 200 cells/microliter within 30 days prior to Step 1 registration
    • Note: HIV testing is not required for eligibility for this protocol

    Pregnant or lactating women or women of childbearing potential and male participants who are sexually active and not willing/able to use medically acceptable forms of contraception

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  • open for enrollment

    Whole-Brain Radiation Therapy or Stereotactic Radiosurgery with or without Lapatinib Ditosylate in Treating Patients with Brain Metastasis from HER2-Positive Breast Cancer

    Protocol: RTOG-1119

    Eligibility:

    Inclusion Criteria:

    Pathologically (histologically or cytologically) proven diagnosis of invasive breast cancer

    HER2-overexpressing breast cancer (3+ staining by immunohistochemistry or HER2 gene amplification by fluorescent in situ hybridization [FISH] or silver in situ hybridization [SISH] >= 2.0)

    At least 1 measurable and no more than 10 unirradiated parenchymal brain metastasis within 21 days prior to study entry; the minimum size as measured on T1-weighted gadolinium-enhanced MRI must be as follows according to the number of brain metastases:

    For a single solitary lesion the size must be >= 10 mm

    For 2 or more lesions, the size of at least 2 of the lesions must be >= 5 mm

    Patients may also have the following provided the size requirements above are met:

    • Progressive parenchymal brain metastasis following stereotactic radiosurgery for 1-3 brain metastases, with at least 1 new measurable brain lesion
    • Progressive parenchymal brain metastasis following surgical resection of 1-3 brain metastases, with at least 1 measurable brain lesion

    History/physical examination within 21 days prior to study entry

    Karnofsky performance status >= 60 within 21 days prior to study entry

    Able to swallow and retain oral medication (note: for patients unable to swallow tablets, an oral suspension preparation is acceptable)

    Absolute neutrophil count (ANC) >= 1,200 cells/mm^3

    Platelets >= 70,000 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)

    Creatinine < 1.5 times institutional upper limit of normal

    Bilirubin < 1.5 times institutional upper limit of normal

    Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3.0 times institutional upper limit of normal with or without liver metastasis

    Patient must provide study specific informed consent prior to study entry

    Women of childbearing potential must have a negative serum pregnancy test within 21 days prior to study entry

    Sexually active women of childbearing potential and sexually active men must practice adequate contraception during therapy and for 12 months after protocol treatment completion

    Prior lapatinib is allowed as long as the last dose received was > 21 days prior to study entry and provided the patient has not received it at any time after the diagnosis of brain metastasis

    Exclusion Criteria:

    Prior WBRT

    Prior radiation therapy (RT) (any site) with concurrent lapatinib defined as 1 or more days on which the patient received both radiation therapy and lapatinib on the same day

    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

    Prior invasive malignancy (except non-melanomatous skin cancer, curatively resected thyroid papillary carcinoma, and invasive and non-invasive cancers related to the breast cancer) unless disease free for a minimum of 3 years

    Leptomeningeal disease

    Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields except patients who have progressed following stereotactic radiosurgery for 1-3 brain metastases, with at least one new lesion

    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

    Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; hepatic or biliary disease that is acute or currently active or that requires antiviral therapy (with the exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases, or stable chronic liver disease per investigator assessment)

    History of left ventricular ejection fraction (LVEF) below institutional normal unless repeated and within institutional normal range within 90 days of study entry

    Grade 2 or greater rash of any cause at time of study entry

    Grade 2 or greater diarrhea of any cause at time of study entry

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  • open for enrollment

    Study of Nivolumab Compared to Temozolomide, Given With Radiation Therapy, for Newly-diagnosed Patients With Glioblastoma (GBM, a Malignant Brain Cancer)

    Protocol: OSU-15304

    Eligibility:

    Inclusion Criteria:

    Males and Females, age ≥ 18 years old

    Newly-diagnosed brain cancer or tumor called glioblastoma or GBM

    Tumor test result shows MGMT unmethylated type

    Karnofsky performance status of ≥ 70 (able to care for self)

    Exclusion Criteria:

    Prior treatment for GBM (other than surgical resection)

    Any known tumor outside of the brain

    Recurrent or secondary GBM

    Active known or suspected autoimmune disease

    Biopsy with less than 20% of tumor removed

    Principal Investigator: Raju Raval, MD, DPhil

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