[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"metastatic-lung-small-cell-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:metastatic-lung-small-cell-carcinoma":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100424265","phase-3-testing-if-high-dose-radiation-only-to-the-sites-of-brain-cancer-compared-to-whole-brain-radiation-that-avoids-the-hippocampus-is-better-at-preventing-loss-of-memory-and-thinking-ability-100424265",false,"NCT04804644","Testing if High Dose Radiation Only to the Sites of Brain Cancer Compared to Whole Brain Radiation That Avoids the Hippocampus is Better at Preventing Loss of Memory and Thinking Ability","Phase III Trial of Stereotactic Radiosurgery (SRS) Versus Hippocampal-Avoidant Whole Brain Radiotherapy (HA-WBRT) for Brain Metastases From Small Cell Lung Cancer","Inclusion Criteria:\n\n* Pathologically (histologically or cytologically) proven diagnosis of small cell lung cancer within 5 years of registration. If the original histologic proof of malignancy is greater than 5 years, then pathological (i.e., more recent) confirmation is required (e.g., from a systemic or brain metastasis);\n\n  * Patients with de novo or recurrent small cell lung cancer are permitted.\n* Brain metastases =\\\u003C 4 cm in largest diameter and outside a 5-mm margin around either hippocampus must be visible on contrast-enhanced magnetic resonance imaging (MRI) performed =\\\u003C 21 days prior to study entry.\n\n  * The total tumor volume must be 30 cm\\^3 or less. Lesion volume will be approximated by measuring the lesion's three perpendicular diameters on contrast enhanced, T1-weighted MRI and the product of those diameters will be divided by 2 to estimate the lesion volume (e.g. xyz\u002F2). Alternatively, direct volumetric measurements via slice by slice contouring on a treatment planning software package can be used to calculate the total tumor volume.\n  * Brain metastases can be diagnosed synchronous to the initial diagnosis of small cell lung cancer or metachronous to the initial diagnosis and management of small cell lung cancer.\n  * Brain metastases must be diagnosed on MRI, which will include the following elements:\n\n    * REQUIRED MRI ELEMENTS\n\n      * Post gadolinium contrast-enhanced T1-weighted three-dimensional (3D) spoiled gradient (SPGR). Acceptable 3D SPGR sequences include magnetization prepared 3D gradient recalled echo (GRE) rapid gradient echo (MP-RAGE), turbo field echo (TFE) MRI, BRAVO (Brain Volume Imaging) or 3D Fast FE (field echo). The T1-weighted 3D scan should use the smallest possible axial slice thickness, not to exceed 1.5 mm.\n      * Pre-contrast T1 weighted imaging (3D imaging sequence strongly encouraged).\n      * A minimum of one axial T2 FLAIR (preferred) or T2 sequence is required. This can be acquired as a two dimensional (2D) or 3D image. If 2D, the images should be obtained in the axial plane.\n    * ADDITIONAL RECOMMENDATIONS\n\n      * Recommendation is that an axial T2 FLAIR (preferred) sequence be performed instead of a T2 sequence.\n      * Recommendation is that that pre-contrast 3D T1 be performed with the same parameters as the post-contrast 3D T1.\n      * Recommendation is that imaging be performed on a 3 Tesla (3T) MRI.\n      * Recommendation is that the study participants be scanned on the same MRI instrument at each time point.\n      * Recommendation is that if additional sequences are obtained, these should meet the criteria outlined in Kaufmann et al., 2020.\n      * If additional sequences are obtained, total imaging time should not exceed 60 minutes.\n      * If additional metastases not known at the time of registration\u002Frandomization or seen in the MRI used for eligibility are subsequently found on the radiation therapy (RT) planning MRI such that the total intacranial volume exceeds 30 cm\\^3, the patient is still considered eligible.\n* History\u002Fphysical examination\n* Age \\>= 18\n* Karnofsky performance status of \\>= 70\n* Creatinine clearance \\>= 30 ml\u002Fmin\n* Following the diagnosis of brain metastases, patients can initiate and treat with systemic (chemotherapy and\u002For immunotherapy) before enrollment only if their brain metastases are asymptomatic and not located in eloquent locations (e.g., brainstem, pre-\u002Fpost-central gyrus, visual cortex). However, within 21 days prior to enrollment, brain MRI must be repeated to confirm eligibility.\n\n  * Patients with symptomatic brain metastases and\u002For brain metastases in eloquent locations (e.g., brainstem, pre-\u002Fpost central gyrus, visual cortex) are eligible for enrollment on the trial; however, the specific treatment approach of starting with systemic therapy alone and delaying brain radiation is not recommended for these patients.\n* Concurrent immunotherapy with brain radiation (SRS or HA-WBRT) is permitted.\n* Negative urine or serum pregnancy test (in women of childbearing potential) within 14 days prior to registration. Women of childbearing potential and men who are sexually active must use contraception while on study.\n* Patients may have had prior intracranial surgical resection.\n* Because neurocognitive testing is the primary goal of this study, patients must be proficient in English or French Canadian.\n* The patient must provide study-specific informed consent prior to study entry.\n\n  * Patients with impaired decision-making capacity are not permitted on study.\n* ELIGIBILITY CRITERIA PRIOR TO STEP 2 REGISTRATION\n* The following baseline neurocognitive tests must be completed within 21 days prior to Step 2 registration: HVLT-R, TMT, and COWA. The neurocognitive test will be uploaded into RAVE for evaluation by Dr. Wefel. Once the upload is complete, within 3 business days a notification will be sent via email to the RA to proceed to Step 2.\n\n  * NOTE: Completed baseline neurocognitive tests can be uploaded at the time of Step 1 registration.\n* PRIOR TO STEP 2 REGISTRATION: The following baseline neurocognitive tests must be completed within 21 days prior to Step 2 registration: HVLT-R, TMT, and COWA. The neurocognitive tests will be uploaded into RAVE for evaluation by Dr. Wefel. Once the upload is complete, within 3 business days a notification will be sent via email to the RA to proceed to Step 2.\n\nNOTE: Completed baseline neurocognitive tests can be uploaded at the time of Step 1 registration.\n\nExclusion Criteria:\n\n* Planned infusion of cytotoxic chemotherapy on the same day as SRS or HA-WBRT treatment. Patients may have had prior chemotherapy. Concurrent immunotherapy is permitted.\n\n  * For patients receiving fractionated SRS on an every-other-day basis, planned infusion of cytotoxic chemotherapy is not permitted between SRS treatments.\n* Brainstem metastasis \\> 10 cm\\^3\n* Prior allergic reaction to memantine.\n* Patients with definitive leptomeningeal metastases.\n* Known history of demyelinating disease such as multiple sclerosis.\n* Contraindication to MR imaging such as implanted metal devices that are MRI-incompatible, allergy to MRI contrast that cannot be adequately addressed with pre-contrast medications, or foreign bodies that preclude MRI imaging. (Questions regarding MRI compatibility of implanted objects should be reviewed with the Radiology Department performing the MRI).\n* Current use of (other N-methyl-D-aspartate \\[NMDA\\] antagonists) amantadine, ketamine, or dextromethorphan.\n* Radiographic evidence of hydrocephalus or other architectural change of the ventricular system resulting in significant anatomic distortion of the hippocampus, including placement of external ventricular drain or ventriculoperitoneal shunt.\n\n  * Mild cases of hydrocephalus not resulting in significant anatomic distortion of the hippocampus are permitted.\n* Prior radiotherapy to the brain, including SRS, WBRT, or prophylactic cranial irradiation (PCI).","ALL","18 Years",{"count":19,"type":20},200,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","This phase III trial compares the effect of stereotactic radiosurgery to standard of care memantine and whole brain radiation therapy that avoids the hippocampus (the memory zone of the brain) for the treatment of small cell lung cancer that has spread to the brain. Stereotactic radiosurgery is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may cause less damage to normal tissue. Whole brain radiation therapy delivers a low dose of radiation to the entire brain including the normal brain tissue. Hippocampal avoidance during whole-brain radiation therapy (HA-WBRT) decreases the amount of radiation that is delivered to the hippocampus which is a brain structure that is important for memory. The drug, memantine, is also often given with whole brain radiotherapy because it may decrease the risk of side effects related to thinking and memory. Stereotactic radiosurgery may decrease side effects related to memory and thinking compared to standard of care HA-WBRT plus memantine.",[26,27,28,29],"Metastatic Lung Small Cell Carcinoma","Metastatic Malignant Neoplasm in the Brain","Recurrent Lung Small Cell Carcinoma","Stage IV Lung Cancer AJCC v8","RECRUITING","2026-06-30",{"date":33,"type":34},"2026-07-01","ACTUAL",{"date":36,"type":34},"2021-06-08",{"date":38,"type":20},"2030-07-01",{"name":40,"class":41},"NRG Oncology","OTHER",231,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":21,"phases":52,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":68},"100433073","phase-2-temozolomide-and-atezolizumab-for-subsequent-line-for-the-treatment-of-metastatic-or-recurrent-small-cell-lung-cancer-100433073","NCT04919382","Temozolomide and Atezolizumab for Subsequent Line for the Treatment of Metastatic or Recurrent Small Cell Lung Cancer","A Randomized, Multi-Cohort Phase II Trial of Temozolomide and Atezolizumab for Subsequent Line Treatment for Small Cell Lung Cancer","Inclusion Criteria:\n\n* Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information\n\n  * NOTE: HIPAA authorization may be included in the informed consent or obtained separately\n* Age \\>= 18 years at the time of consent\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 2 within 28 days prior to registration\n* Have histologically or cytologically-documented diagnosis of extensive stage (i.e. metastatic and\u002For recurrent) small cell lung cancer and have progressed or recurred after platinum-based chemotherapy with immunotherapy. Eligible patients will be defined as follows:\n\n  * \"Sensitive\" Disease: Patients who had one previous line of chemotherapy and relapsed after \\> 90 days of completion of treatment\n  * \"Resistant\" Disease: Patients with no response to first-line chemo-immunotherapy or progression \\\u003C 90 days after completing treatment\n* Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 within 28 days prior to registration\n* Maximum of 3 prior lines of systemic therapy is allowed in the setting of metastatic disease. Patients who recur after treatment for limited state disease, and who receive first line metastatic treatment with chemo-immunotherapy would be considered eligible upon progression on chemo-IO in the metastatic setting\n* Absolute neutrophil count (ANC) \\>= 1.5 K\u002Fmm\\^3 (obtained within 28 days prior to registration)\n* Platelets \\>= 100,000 \u002F mcL (obtained within 28 days prior to registration)\n* Serum creatinine =\\\u003C 2.0 X upper limit of normal (ULN) OR measured or calculated creatinine clearance (glomerular filtration rate \\[GFR\\] can also be used in place of creatinine or creatinine clearance \\[CrCl\\]) \\>= 50 mL\u002Fmin as estimated by Cockcroft and Gault formula for subject with creatinine levels \\> 2 x institutional ULN (obtained within 28 days prior to registration)\n* Bilirubin =\\\u003C 1.5 X ULN OR direct bilirubin =\\\u003C ULN for subjects with total bilirubin levels \\> 1.5 ULN\n\n  * Patients with known Gilbert disease: serum bilirubin =\\\u003C 3 x ULN) (obtained within 28 days prior to registration)\n* Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) =\\\u003C 3 X ULN OR =\\\u003C 5 X ULN for subjects with liver metastases (obtained within 28 days prior to registration)\n* Albumin \\> 2.5 g\u002FdL (obtained within 28 days prior to registration)\n* International normalized ratio (INR) or prothrombin time (PT) =\\\u003C 1.5 x ULN for patients not receiving therapeutic anticoagulation (obtained within 28 days prior to registration)\n\n  * For patients receiving therapeutic anticoagulation: stable anticoagulant regimen\n* Activated partial thromboplastin time (aPTT) =\\\u003C 1.5 x ULN for patients not receiving therapeutic anticoagulation (obtained within 28 days prior to registration)\n\n  * For patients receiving therapeutic anticoagulation: stable anticoagulant regimen\n* Females of childbearing potential must have a negative serum or urine pregnancy test within 14 days prior to registration\n* For women of childbearing potential: agreement to remain abstinent (refrain from vaginal intercourse) or use contraceptive methods and agreement to refrain from donating eggs, as defined below:\n\n  * Women must remain abstinent or use contraceptive methods with a failure rate of \\\u003C 1% per year during the treatment period and for 5 months after the final dose of atezolizumab or temozolomide. Women must refrain from donating eggs during this same period\n  * Examples of contraceptive methods with a failure rate of \\\u003C 1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone releasing intrauterine devices, and copper intrauterine devices\n  * The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, sympto-thermal, or post ovulation methods) and withdrawal are not adequate methods of contraception\n* For men able to father a child: agreement to remain abstinent (refrain from vaginal intercourse) or use a condom, and agreement to refrain from donating sperm, as defined below:\n\n  * With a female partner of childbearing potential or pregnant female partner, men must remain abstinent or use a condom during the treatment period and for 3 months after the final dose of temozolomide to avoid exposing the embryo. Men must refrain from donating sperm during this same period\n  * The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not adequate methods of contraception\n* As determined by the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study\n* Availability of archival tissue, preferably a recent formalin-fixed, paraffin-embedded (FFPE) tumor tissue block. A recently obtained archival FFPE tumor tissue block from a primary or metastatic tumor resection or biopsy can be provided if it was obtained within 1 year of trial screening. Patients with tumor specimens older than 1 year, or who do not have biopsy specimen may still be eligible if deemed so by the sponsor-investigator.\n* Be willing to provide peripheral blood samples at specified time-points during the study\n* Life expectancy greater than 3 months as determined by the enrolling physician or protocol designee\n* Ability to swallow and retain oral medication\n\nExclusion Criteria:\n\n* Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment\n* Has received prior temozolomide therapy\n* Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen are not eligible for this trial\n* Symptomatic central nervous system (CNS) metastases or untreated or actively progressing CNS metastases. Subjects with asymptomatic CNS metastases (treated or untreated) will be eligible provided all of the following criteria are met.\n\n  1. Measurable disease, per RECIST v1.1, must be present outside the CNS.\n  2. The patient has no history of intracranial hemorrhage or spinal cord hemorrhage.\n  3. The patient has not undergone stereotactic radiotherapy within 7 days prior to initiation of study treatment, whole-brain radiotherapy within 14 days prior to initiation of study treatment, or neurosurgical resection within 28 days prior to initiation of study treatment.\n  4. The patient has no ongoing requirement for corticosteroids as therapy for CNS disease at the time of study treatment.\n  5. If the patient is receiving anti-convulsant therapy, the dose is considered stable and appropriate by the treating physician.\n  6. Metastases are limited to the cerebellum or the supratentorial region (i.e., no metastases to the midbrain, pons, medulla, or spinal cord).\n\n     * NOTE: Subjects who are symptomatic and have not undergone prior brain imaging must undergo a head computed tomography (CT) scan or brain MRI within 28 days prior to registration to exclude brain metastases\n     * NOTE: A subject with previously treated brain metastasis may be considered if they have completed their treatment for brain metastasis at least 2 weeks prior to study registration and all of the above criteria are met.\n* Clinically significant acute infection requiring systemic antibacterial, antifungal, or antiviral therapy including:\n\n  * Tuberculosis (clinical evaluation that includes clinical history, physical examination, and radiographic findings, and TB testing in line with local practice)\n  * Hepatitis B (known positive HBV surface antigen \\[HBsAg\\] result)\n  * Hepatitis C, or\n  * Human immunodeficiency virus (positive HIV 1\u002F2 antibodies)\n  * NOTES: Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody \\[anti-HBc\\] and absence of HBsAg) are eligible. In patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV ribonucleic acid (RNA). Subjects with HIV\u002Facquired immunodeficiency syndrome (AIDS) with adequate antiviral therapy to control viral load (i.e undetectable) would be allowed if they are stable and have been on treatment for \\>= 4 weeks prior to first dose of study drug(s). Subjects with viral hepatitis with controlled viral load would be allowed while on suppressive antiviral therapy. Testing not required\n* Has had prior chemotherapy, immunotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study day 1 or who has not recovered (i.e., =\\\u003C grade 1 or at baseline) from adverse events due to a previously administered agent\n\n  * Note: Subjects with =\\\u003C grade 2 neuropathy or alopecia due to chemotherapy are an exception to this criterion and may qualify for the study\n  * Note: If subject received major surgery, they must have recovered adequately from the toxicity and\u002For complications from the intervention prior to starting therapy\n  * Note: Subjects with irreversible toxicity that in the opinion of the treating physician is not reasonably expected to be exacerbated by the investigational product may be included (e.g., hearing loss, hormone deficiency requiring replacement therapy)\n* Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjogren syndrome, Guillain-Barre syndrome, or multiple sclerosis, with the following exceptions:\n\n  * Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment\n  * Patients with controlled type 1 diabetes mellitus who are on an insulin regimen are eligible for the study\n  * Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are eligible for the study provided all of following conditions are met:\n\n    * Rash must cover =\\\u003C 10% of body surface area\n    * Disease is well controlled at baseline and requires only low-potency topical corticosteroids\n    * No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency or oral corticosteroids within the previous 12 months\n* History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted\n* Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina\n* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial\n* Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment\n* Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study)\n* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator\n* History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins\n* Known hypersensitivity to Chinese hamster ovary cell products or to any component of the atezolizumab formulation\n* Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (more than once monthly). Patients with indwelling catheters (e.g., PleurX) are allowed.\n* Uncontrolled or symptomatic hypercalcemia (ionized calcium \\> 1.5 mmol\u002FL, calcium \\>12 mg\u002FdL or corrected serum calcium \\> ULN)\n* History of leptomeningeal disease",{"count":51,"type":20},56,[53],"PHASE2","This phase II trial studies the effects of temozolomide and atezolizumab as second or third line treatment for patients with small cell lung cancer that has spread to other places in the body (metastatic) or has come back (recurrent). Chemotherapy drugs, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving temozolomide and atezolizumab as second or third line treatment may help prolong survival in patients with small cell lung cancer.",[56,26,28,29,57,58],"Extensive Stage Lung Small Cell Carcinoma","Stage IVA Lung Cancer AJCC v8","Stage IVB Lung Cancer AJCC v8","2026-04-02",{"date":61,"type":34},"2026-04-08",{"date":63,"type":34},"2022-01-26",{"date":65,"type":20},"2028-12-30",{"name":67,"class":41},"Dwight Owen",5]