Whole-Brain Radiation Therapy With or Without Hippocampal Avoidance in Treating Patients With Limited Stage or Extensive Stage Small Cell Lung Cancer
Study Details
Study Description
Brief Summary
This randomized phase II/III trial studies how well whole-brain radiation therapy works and compares it with or without hippocampal avoidance in treating patients with small cell lung cancer that is found in one lung, the tissues between the lungs, and nearby lymph nodes only (limited stage) or has spread outside of the lung in which it began or to other parts of the body (extensive stage). Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. The hippocampus is part of the brain that is important for memory. Avoiding the hippocampus during whole-brain radiation could decrease the chance of side effects on memory and thinking. It is not yet known whether giving whole-brain radiation therapy is more effective with or without hippocampal avoidance in treating patients with small cell lung cancer.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2/Phase 3 |
Detailed Description
PRIMARY OBJECTIVES:
- Determine whether the 12-month intracranial relapse rate following hippocampal avoidance (HA)-prophylactic cranial irradiation (PCI) is non-inferior compared to the rate following PCI for patients with small cell lung cancer (SCLC). (Randomized Phase II Component [Non-Inferiority]) II. Determine whether HA-PCI reduces the likelihood of 6-month deterioration from baseline in Hopkins Verbal Learning Test (HVLT)-Revised (R) delayed recall compared to PCI for patients with SCLC. (Phase III Component [Efficacy])
SECONDARY OBJECTIVES:
-
Compare time to cognitive failure, as measured by a battery of tests (HVLT-R, Controlled Oral Word Association [COWA] test, and Trail Making Test [TMT] parts A and B), after PCI versus HA-PCI in SCLC.
-
Compare time to cognitive failure as separately measured by each test (HVLT-R for Total Recall and Delayed Recognition, COWA test, and TMT parts A and B), after PCI versus HA-PCI for SCLC.
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Compare patient-reported cognitive functioning and other quality of life domains (assessed by the European Organization for Research and Treatment of Cancer [EORTC] Quality of Life Questionnaire [QLQ]-Core [C]30 and BN20) between PCI versus HA-PCI for patients with SCLC.
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Compare overall survival after PCI versus HA-PCI for patients with SCLC. V. Compare 12-month intracranial relapse rate (at completion of phase III) and time to intracranial relapse after PCI versus HA-PCI for patients with SCLC.
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Evaluate adverse events according to Common Terminology Criteria for Adverse Events (CTCAE) criteria.
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Correlate changes in health-related quality of life (HRQOL) domains with changes in cognitive testing outcomes following PCI versus HA-PCI for patients with SCLC.
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Assess cost-effectiveness of HA-PCI (intensity modulated radiation therapy [IMRT]) and PCI (3-dimensional conformal radiation therapy [3DCRT]) using the EuroQual (EQ)-5-Dimensions (5D)-5L.
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Correlate miRNA signatures with cognitive failure in SCLC patients who received PCI and HA-PCI.
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Evaluate APOE genotyping as potential predictor of neurocognitive decline, hippocampal atrophy after brain irradiation and/or differential benefit from hippocampal avoidance.
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Evaluate baseline MR imaging biomarkers of white matter injury and hippocampal volumetry as potential predictors of cognitive decline and differential benefit from HA-PCI as compared to PCI.
TERTIARY OBJECTIVES:
-
Collect serum, whole blood, and urine for future translational research analyses.
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Evaluate baseline magnetic resonance (MR) imaging biomarkers of white matter injury and hippocampal volumetry as potential predictors of cognitive decline and differential benefit from HAPCI as compared to PCI.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients undergo PCI using 3DCRT daily for 2 weeks.
ARM II: Patients undergo PCI with HA using IMRT daily for 2 weeks.
After completion of study treatment, patients are followed every 3 months for 1 year, then every 6 months until 3 years and then annually until death.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Arm I (PCI using 3DCRT) Patients undergo PCI using 3DCRT daily for 2 weeks. |
Radiation: 3-Dimensional Conformal Radiation Therapy
Undergo PCI using 3DCRT
Other Names:
Other: Cognitive Assessment
Ancillary studies
Other: Laboratory Biomarker Analysis
Correlative studies
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
|
| Experimental: Arm II (PCI with HA using IMRT) Patients undergo PCI with HA using IMRT daily for 2 weeks. |
Other: Cognitive Assessment
Ancillary studies
Radiation: Intensity-Modulated Radiation Therapy
Undergo PCI with HA using IMRT
Other Names:
Other: Laboratory Biomarker Analysis
Correlative studies
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
|
Outcome Measures
Primary Outcome Measures
- HVLT-R delayed recall deterioration status, defined using the Reliable Change Index (RCI) (Phase III) [6 months from start of treatment]
Compared using Fisher's exact test at a significance level of 0.05.
- Intracranial relapse rate (Phase II) [12 months]
It will be compared between arms using a binomial test of difference in proportions at a significance level of 0.1. If the rate of relapse in the HA-PCI arm is significantly greater than that of the PCI only arm, this study will not continue to the phase III portion.
Secondary Outcome Measures
- Cost-effectiveness as measured by the EQ-5D (Phase III) [Up to 3 years]
Quality-adjusted life years (QALY's) will be assessed as the area under the preference-weighted survival curve. Cost will be assessed using a societal perspective. The primary cost-effectiveness outcome will be the pooled incremental cost-per QALY ratio for HA-PCI versus standard PCI. The incremental cost per QALY ratio will be calculated as the total cost of the HA-PCI minus total cost of standard PCI which will be divided by the quality adjusted survival of the patients treated with HA-PCI minus the quality adjusted survival of patients receiving standard PCI.
- Incidence of adverse events (AEs), as measured by the CTCAE v.4 (Phase III) [Up to 3 years]
Counts of all AEs by grade will be provided by treatment arm. Counts and frequencies will be provided for the worst grade AE experienced by the patient by treatment arm.
- Intracranial relapse rate (Phase III) [Up to 12 months]
The occurrence of intracranial relapse will be defined as appearance of brain metastasis in brain. Cumulative incidence approach will be used to estimate the median time to intracranial relapse to account for the competing risk of death. Gray's test will be used to test for statistically significant difference in the distribution of intracranial relapse times. Cause-specific Cox proportional hazards regression model will be used to evaluate effect of stratification variables (age, stage, and planned concurrent memantine use) and other baseline characteristics, on time to intracranial relapse.
- Overall survival (Phase III) [From the date of randomization to the date of death, or, otherwise, the last follow-up date on which the patient was reported alive, assessed up to 3 years]
Estimated using the Kaplan-Meier method and differences between treatment arms will be tested using the log rank test. The Cox proportional hazard model will be performed with the stratification variables and other baseline characteristics as fixed variables to assess the treatment effect while adjusting for patient-specific risk factors.
- Patient-reported HRQOL, as measured by the EORTC QLQ-C30 and BN20 (Phase III) [Up to 24 months]
Correlation of changes in HRQOL domains measured by the EORTC QLQ-C30 and BN20 with changes in cognitive function will be assessed. Additionally cognitive function decline at 3, 6, 12, 18 and 24 months will also be assessed and compared using Fisher's exact test. Decline from baseline to each time point (3, 6, 12, 18, and 24 months from the start of treatment) in the following subscales will also be assessed and compared using Fisher's exact test: global QOL, physical functioning, role functioning, emotional functioning, and social functioning domains along with fatigue and pain items.
- Preservation of neurocognitive function, as measured by neurocognitive decline for HVLT-R, COWA test, TMT Parts A and B, and Clinical Trial Battery Composite (CTB COMP) score (Phase III) [Up to 24 months]
Standardized scores that adjust for age, education, and gender when necessary will be analyzed. For discrete time point analyses, the change from baseline to each follow-up time point (3, 6, 12, 18, and 24 months from the start of treatment) will be calculated and compared between treatment arms using a t-test or Wilcoxon-Mann- Whitney test, depending on the normality of the data. Neurocognitive decline using the RCI for the HVLT-R, COWA, and TMT also will be compared between treatment arms at each follow-up time point using Fisher's exact test.
- Time to neurocognitive failure, where a failure is defined using the RCI criteria, as measured by HVLT-R, COWA test, and TMT Parts A and B (Phase III) [Up to 3 years]
The cumulative incidence approach will be used to estimate the median time to neurocognitive failure to account for the competing risk of death. Gray's test will be used to test for statistically significant difference in the distribution of neurocognitive failure times. The cause-specific Cox proportional hazards regression model will be used to evaluate the effect of stratification variables (age, stage, and planned concurrent memantine use) and other baseline characteristics, on time to neurocognitive decline.
Other Outcome Measures
- White matter injury and hippocampal volume on neurocognitive function [Baseline to 6 months]
The change from baseline to 6 months will be compared between arms using the t-test (or Wilcoxon test if not normally distributed) in the total score and the two subscale scores (agency and pathway). These scores will be correlated with the EORTC- QLQ-C30 total score using a Pearson correlation coefficient. A general linear model will be used to assess hopefulness, performed separately for the AHS total score and subscale scores, between treatment arms while adjusting for depression.
Eligibility Criteria
Criteria
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
-
High-grade neuroendocrine carcinoma or combined SCLC and NSCLC is permitted.
-
Patients must have received chemotherapy and be registered to Step 1 registration no earlier than 7 days and no later than 56 days after completing chemotherapy. Note:
-
Post-chemotherapy restaging imaging must be completed no more than 56 days prior to Step 1 registration.
-
For patients with extensive-stage small cell lung cancer who are being considered for consolidative thoracic radiotherapy after chemotherapy, concomitant administration of consolidative thoracic radiotherapy and protocol-specified prophylactic cranial irradiation with or without hippocampal avoidance is permitted.
-
Patients must have a gadolinium contrast-enhanced three-dimensional (3D), spoiled gradient (SPGR), magnetization-prepared rapid gradient echo (MP-RAGE), or turbo field echo (TFE) MRI scan (see section 11.3 regarding axial T2/FLAIR sequence). To yield acceptable image quality, the gadolinium contrast-enhanced three-dimensional SPGR, MP-RAGE or TFE axial MRI scan must use the smallest possible axial slice thickness not exceeding 1.5 mm. Sites may contact the Imaging Co-Chairs for further information or assistance if needed.
-
This MRI must be obtained within 56 days prior to Step 1 registration. Note: The MRI study is mandatory irrespective of randomization to the experimental or control arm of this study.
-
Prior to chemotherapy +/- thoracic radiotherapy, patients must be defined as limited-stage or extensive-stage SCLC after clinical staging evaluation involving the following:
-
History/physical examination;
-
CT of the chest and abdomen with contrast (does not have to be done if the patient has had a PET/CT scan prior to initiating chemotherapy or thoracic radiotherapy);
-
MRI of the brain with contrast or diagnostic head CT with contrast;
-
For patients without evidence of extensive-stage SCLC on chest and abdomen CT and brain MRI or head CT, a PET/CT or bone scan is required to confirm limited-stage SCLC.
-
After chemotherapy, patients must be restaged prior to 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 within 30 days of Step 1 registration;
-
No CNS metastases (Repeat MRI required; see Section 3.2.3 for details) within 56 days prior to Step 1 registration;
-
No progression in any site;
-
Radiographic partial or complete response to chemotherapy in at least one disease site within 56 days prior to Step 1 registration.
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If PET/CT was obtained prior to chemotherapy, either a repeat PET/CT or CT of the chest and abdomen with contrast can be obtained for response assessment.
-
Patients who underwent resection for limited-stage SCLC prior to chemotherapy and have no radiographically evident disease for response assessment remain eligible if post-chemotherapy imaging demonstrates no progression.
-
Zubrod performance status 0-2
-
Women of childbearing potential and male participants must practice adequate contraception
-
Women of childbearing potential must have a negative qualitative serum pregnancy test =< 2 weeks prior to study entry
-
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 or at the time of Step 1 registration: HVLT-R (recall, delayed recall, and recognition), TMT (Parts A and B), and COWA. The neurocognitive assessments will be uploaded into the NRG Oncology RAVE System for evaluation by Dr. Wefel. Once the upload is complete, within 3 business days, a notification email will be sent to the site to proceed to Step 2 registration. At minimum, the HVLT-R delayed recall must be able to be scored (i.e. completed without error) in order to be eligible.
-
Patients must have a baseline raw score greater than 2 on the HVLT-R delayed recall
Exclusion Criteria:
-
Prior radiotherapy to the head or neck (except for T1 glottic cancer), resulting in overlap of radiation fields
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Radiographic evidence of CNS metastases
-
Radiographic evidence of hydrocephalus or other architectural distortion of the ventricular system, including placement of external ventricular drain or ventriculoperitoneal shunt
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Planned concurrent chemotherapy or anti-tumor agent during PCI
-
Concurrent atezolizumab permitted
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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
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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
-
HIV positive with CD4 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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Alabama at Birmingham Cancer Center | Birmingham | Alabama | United States | 35233 |
| 2 | Lewis and Faye Manderson Cancer Center | Tuscaloosa | Alabama | United States | 35401 |
| 3 | Banner University Medical Center - Tucson | Tucson | Arizona | United States | 85719 |
| 4 | Marin General Hospital | Greenbrae | California | United States | 94904 |
| 5 | Los Angeles County-USC Medical Center | Los Angeles | California | United States | 90033 |
| 6 | USC / Norris Comprehensive Cancer Center | Los Angeles | California | United States | 90033 |
| 7 | Mercy UC Davis Cancer Center | Merced | California | United States | 95340 |
| 8 | Kaiser Permanente Oakland-Broadway | Oakland | California | United States | 94611 |
| 9 | Saint Joseph Hospital - Orange | Orange | California | United States | 92868 |
| 10 | Kaiser Permanente-Rancho Cordova Cancer Center | Rancho Cordova | California | United States | 95670 |
| 11 | Sutter Cancer Centers Radiation Oncology Services-Roseville | Roseville | California | United States | 95661 |
| 12 | The Permanente Medical Group-Roseville Radiation Oncology | Roseville | California | United States | 95678 |
| 13 | Sutter Medical Center Sacramento | Sacramento | California | United States | 95816 |
| 14 | University of California Davis Comprehensive Cancer Center | Sacramento | California | United States | 95817 |
| 15 | California Pacific Medical Center-Pacific Campus | San Francisco | California | United States | 94115 |
| 16 | Kaiser Permanente Medical Center - Santa Clara | Santa Clara | California | United States | 95051 |
| 17 | Gene Upshaw Memorial Tahoe Forest Cancer Center | Truckee | California | United States | 96161 |
| 18 | Sutter Solano Medical Center/Cancer Center | Vallejo | California | United States | 94589 |
| 19 | Swedish Medical Center | Englewood | Colorado | United States | 80113 |
| 20 | Poudre Valley Hospital | Fort Collins | Colorado | United States | 80524 |
| 21 | Hartford HealthCare - Saint Vincent's Medical Center | Bridgeport | Connecticut | United States | 06606 |
| 22 | Yale University | New Haven | Connecticut | United States | 06520 |
| 23 | Helen F Graham Cancer Center | Newark | Delaware | United States | 19713 |
| 24 | Christiana Care Health System-Christiana Hospital | Newark | Delaware | United States | 19718 |
| 25 | Boca Raton Regional Hospital | Boca Raton | Florida | United States | 33486 |
| 26 | UM Sylvester Comprehensive Cancer Center at Coral Gables | Coral Gables | Florida | United States | 33146 |
| 27 | Broward Health Medical Center | Fort Lauderdale | Florida | United States | 33316 |
| 28 | University of Miami Miller School of Medicine-Sylvester Cancer Center | Miami | Florida | United States | 33136 |
| 29 | Miami Cancer Institute | Miami | Florida | United States | 33176 |
| 30 | Orlando Health Cancer Institute | Orlando | Florida | United States | 32806 |
| 31 | Moffitt Cancer Center | Tampa | Florida | United States | 33612 |
| 32 | Grady Health System | Atlanta | Georgia | United States | 30303 |
| 33 | Emory University Hospital Midtown | Atlanta | Georgia | United States | 30308 |
| 34 | Emory University Hospital/Winship Cancer Institute | Atlanta | Georgia | United States | 30322 |
| 35 | Northside Hospital | Atlanta | Georgia | United States | 30342 |
| 36 | Northside Hospital-Forsyth | Cumming | Georgia | United States | 30041 |
| 37 | Memorial Health University Medical Center | Savannah | Georgia | United States | 31404 |
| 38 | Lewis Cancer and Research Pavilion at Saint Joseph's/Candler | Savannah | Georgia | United States | 31405 |
| 39 | The Cancer Center of Hawaii-Pali Momi | 'Aiea | Hawaii | United States | 96701 |
| 40 | Queen's Medical Center | Honolulu | Hawaii | United States | 96813 |
| 41 | The Cancer Center of Hawaii-Liliha | Honolulu | Hawaii | United States | 96817 |
| 42 | Saint Alphonsus Cancer Care Center-Boise | Boise | Idaho | United States | 83706 |
| 43 | Saint Luke's Cancer Institute - Boise | Boise | Idaho | United States | 83712 |
| 44 | Saint Alphonsus Cancer Care Center-Caldwell | Caldwell | Idaho | United States | 83605 |
| 45 | Saint Luke's Cancer Institute - Meridian | Meridian | Idaho | United States | 83642 |
| 46 | Saint Alphonsus Medical Center-Nampa | Nampa | Idaho | United States | 83686 |
| 47 | Saint Luke's Cancer Institute - Nampa | Nampa | Idaho | United States | 83686 |
| 48 | Saint Luke's Cancer Institute - Twin Falls | Twin Falls | Idaho | United States | 83301 |
| 49 | Northwestern University | Chicago | Illinois | United States | 60611 |
| 50 | John H Stroger Jr Hospital of Cook County | Chicago | Illinois | United States | 60612 |
| 51 | Rush University Medical Center | Chicago | Illinois | United States | 60612 |
| 52 | Decatur Memorial Hospital | Decatur | Illinois | United States | 62526 |
| 53 | Crossroads Cancer Center | Effingham | Illinois | United States | 62401 |
| 54 | Northwestern Medicine Cancer Center Delnor | Geneva | Illinois | United States | 60134 |
| 55 | Edward Hines Jr VA Hospital | Hines | Illinois | United States | 60141 |
| 56 | Condell Memorial Hospital | Libertyville | Illinois | United States | 60048 |
| 57 | Loyola University Medical Center | Maywood | Illinois | United States | 60153 |
| 58 | Illinois CancerCare-Peoria | Peoria | Illinois | United States | 61615 |
| 59 | Methodist Medical Center of Illinois | Peoria | Illinois | United States | 61636 |
| 60 | OSF Saint Francis Medical Center | Peoria | Illinois | United States | 61637 |
| 61 | Memorial Medical Center | Springfield | Illinois | United States | 62781 |
| 62 | Carle Cancer Center | Urbana | Illinois | United States | 61801 |
| 63 | Northwestern Medicine Cancer Center Warrenville | Warrenville | Illinois | United States | 60555 |
| 64 | Saint Vincent Anderson Regional Hospital/Cancer Center | Anderson | Indiana | United States | 46016 |
| 65 | Parkview Hospital Randallia | Fort Wayne | Indiana | United States | 46805 |
| 66 | Parkview Regional Medical Center | Fort Wayne | Indiana | United States | 46845 |
| 67 | Goshen Center for Cancer Care | Goshen | Indiana | United States | 46526 |
| 68 | IU Health Ball Memorial Hospital | Muncie | Indiana | United States | 47303 |
| 69 | Saint Luke's Hospital | Cedar Rapids | Iowa | United States | 52402 |
| 70 | Mercy Hospital | Cedar Rapids | Iowa | United States | 52403 |
| 71 | Iowa Methodist Medical Center | Des Moines | Iowa | United States | 50309 |
| 72 | University of Kansas Cancer Center | Kansas City | Kansas | United States | 66160 |
| 73 | Lawrence Memorial Hospital | Lawrence | Kansas | United States | 66044 |
| 74 | University of Kansas Cancer Center-Overland Park | Overland Park | Kansas | United States | 66210 |
| 75 | Ascension Via Christi Hospitals Wichita | Wichita | Kansas | United States | 67214 |
| 76 | Wesley Medical Center | Wichita | Kansas | United States | 67214 |
| 77 | University of Kentucky/Markey Cancer Center | Lexington | Kentucky | United States | 40536 |
| 78 | Tulane University Health Sciences Center | New Orleans | Louisiana | United States | 70112 |
| 79 | Anne Arundel Medical Center | Annapolis | Maryland | United States | 21401 |
| 80 | University of Maryland Medical Center | Baltimore | Maryland | United States | 21201 |
| 81 | University of Maryland/Greenebaum Cancer Center | Baltimore | Maryland | United States | 21201 |
| 82 | MedStar Franklin Square Medical Center/Weinberg Cancer Institute | Baltimore | Maryland | United States | 21237 |
| 83 | MedStar Good Samaritan Hospital | Baltimore | Maryland | United States | 21239 |
| 84 | Johns Hopkins University/Sidney Kimmel Cancer Center | Baltimore | Maryland | United States | 21287 |
| 85 | UM Upper Chesapeake Medical Center | Bel Air | Maryland | United States | 21014 |
| 86 | Central Maryland Radiation Oncology in Howard County | Columbia | Maryland | United States | 21044 |
| 87 | UM Baltimore Washington Medical Center/Tate Cancer Center | Glen Burnie | Maryland | United States | 21061 |
| 88 | TidalHealth Richard A Henson Cancer Institute | Ocean Pines | Maryland | United States | 21811 |
| 89 | TidalHealth Peninsula Regional | Salisbury | Maryland | United States | 21801 |
| 90 | UM Saint Joseph Medical Center | Towson | Maryland | United States | 21204 |
| 91 | Lahey Hospital and Medical Center | Burlington | Massachusetts | United States | 01805 |
| 92 | Lowell General Hospital | Lowell | Massachusetts | United States | 01854 |
| 93 | UMass Memorial Medical Center - University Campus | Worcester | Massachusetts | United States | 01655 |
| 94 | Saint Joseph Mercy Hospital | Ann Arbor | Michigan | United States | 48106 |
| 95 | McLaren Cancer Institute-Bay City | Bay City | Michigan | United States | 48706 |
| 96 | Saint Joseph Mercy Brighton | Brighton | Michigan | United States | 48114 |
| 97 | Henry Ford Cancer Institute-Downriver | Brownstown | Michigan | United States | 48183 |
| 98 | Saint Joseph Mercy Chelsea | Chelsea | Michigan | United States | 48118 |
| 99 | GenesisCare USA - Clarkston | Clarkston | Michigan | United States | 48346 |
| 100 | McLaren Cancer Institute-Clarkston | Clarkston | Michigan | United States | 48346 |
| 101 | Henry Ford Macomb Hospital-Clinton Township | Clinton Township | Michigan | United States | 48038 |
| 102 | Beaumont Hospital - Dearborn | Dearborn | Michigan | United States | 48124 |
| 103 | Wayne State University/Karmanos Cancer Institute | Detroit | Michigan | United States | 48201 |
| 104 | Henry Ford Hospital | Detroit | Michigan | United States | 48202 |
| 105 | GenesisCare USA - Farmington Hills | Farmington Hills | Michigan | United States | 48334 |
| 106 | Genesys Hurley Cancer Institute | Flint | Michigan | United States | 48503 |
| 107 | McLaren Cancer Institute-Flint | Flint | Michigan | United States | 48532 |
| 108 | Mercy Health Saint Mary's | Grand Rapids | Michigan | United States | 49503 |
| 109 | Spectrum Health at Butterworth Campus | Grand Rapids | Michigan | United States | 49503 |
| 110 | West Michigan Cancer Center | Kalamazoo | Michigan | United States | 49007 |
| 111 | McLaren Cancer Institute-Lapeer Region | Lapeer | Michigan | United States | 48446 |
| 112 | Saint Mary Mercy Hospital | Livonia | Michigan | United States | 48154 |
| 113 | GenesisCare USA - Macomb | Macomb | Michigan | United States | 48044 |
| 114 | McLaren Cancer Institute-Macomb | Mount Clemens | Michigan | United States | 48043 |
| 115 | McLaren Cancer Institute-Central Michigan | Mount Pleasant | Michigan | United States | 48858 |
| 116 | Mercy Health Mercy Campus | Muskegon | Michigan | United States | 49444 |
| 117 | McLaren Cancer Institute-Owosso | Owosso | Michigan | United States | 48867 |
| 118 | McLaren Cancer Institute-Northern Michigan | Petoskey | Michigan | United States | 49770 |
| 119 | Saint Joseph Mercy Oakland | Pontiac | Michigan | United States | 48341 |
| 120 | McLaren-Port Huron | Port Huron | Michigan | United States | 48060 |
| 121 | William Beaumont Hospital-Royal Oak | Royal Oak | Michigan | United States | 48073 |
| 122 | Lakeland Medical Center Saint Joseph | Saint Joseph | Michigan | United States | 49085 |
| 123 | William Beaumont Hospital - Troy | Troy | Michigan | United States | 48085 |
| 124 | GenesisCare USA - Troy | Troy | Michigan | United States | 48098 |
| 125 | Henry Ford West Bloomfield Hospital | West Bloomfield | Michigan | United States | 48322 |
| 126 | Mayo Clinic Health System in Albert Lea | Albert Lea | Minnesota | United States | 56007 |
| 127 | Saint Luke's Hospital of Duluth | Duluth | Minnesota | United States | 55805 |
| 128 | Mayo Clinic Health Systems-Mankato | Mankato | Minnesota | United States | 56001 |
| 129 | Abbott-Northwestern Hospital | Minneapolis | Minnesota | United States | 55407 |
| 130 | Mayo Clinic Radiation Therapy-Northfield | Northfield | Minnesota | United States | 55057 |
| 131 | Mayo Clinic in Rochester | Rochester | Minnesota | United States | 55905 |
| 132 | Park Nicollet Clinic - Saint Louis Park | Saint Louis Park | Minnesota | United States | 55416 |
| 133 | Saint Francis Medical Center | Cape Girardeau | Missouri | United States | 63703 |
| 134 | Siteman Cancer Center at West County Hospital | Creve Coeur | Missouri | United States | 63141 |
| 135 | Freeman Health System | Joplin | Missouri | United States | 64804 |
| 136 | Saint Luke's Hospital of Kansas City | Kansas City | Missouri | United States | 64111 |
| 137 | North Kansas City Hospital | Kansas City | Missouri | United States | 64116 |
| 138 | University of Kansas Cancer Center - North | Kansas City | Missouri | United States | 64154 |
| 139 | University of Kansas Cancer Center at North Kansas City Hospital | North Kansas City | Missouri | United States | 64116 |
| 140 | Washington University School of Medicine | Saint Louis | Missouri | United States | 63110 |
| 141 | Siteman Cancer Center-South County | Saint Louis | Missouri | United States | 63129 |
| 142 | Missouri Baptist Medical Center | Saint Louis | Missouri | United States | 63131 |
| 143 | Mercy Hospital Saint Louis | Saint Louis | Missouri | United States | 63141 |
| 144 | Billings Clinic Cancer Center | Billings | Montana | United States | 59101 |
| 145 | Benefis Healthcare- Sletten Cancer Institute | Great Falls | Montana | United States | 59405 |
| 146 | Community Medical Hospital | Missoula | Montana | United States | 59804 |
| 147 | University of Nebraska Medical Center | Omaha | Nebraska | United States | 68198 |
| 148 | Renown Regional Medical Center | Reno | Nevada | United States | 89502 |
| 149 | Wentworth-Douglass Hospital | Dover | New Hampshire | United States | 03820 |
| 150 | Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | United States | 03756 |
| 151 | Memorial Sloan Kettering Basking Ridge | Basking Ridge | New Jersey | United States | 07920 |
| 152 | Englewood Hospital and Medical Center | Englewood | New Jersey | United States | 07631 |
| 153 | Memorial Sloan Kettering Monmouth | Middletown | New Jersey | United States | 07748 |
| 154 | Virtua Memorial | Mount Holly | New Jersey | United States | 08060 |
| 155 | Virtua Voorhees | Voorhees | New Jersey | United States | 08043 |
| 156 | University of New Mexico Cancer Center | Albuquerque | New Mexico | United States | 87102 |
| 157 | Northwell Health Imbert Cancer Center | Bay Shore | New York | United States | 11706 |
| 158 | Montefiore Medical Center-Einstein Campus | Bronx | New York | United States | 10461 |
| 159 | Montefiore Medical Center - Moses Campus | Bronx | New York | United States | 10467 |
| 160 | New York-Presbyterian/Brooklyn Methodist Hospital | Brooklyn | New York | United States | 11215 |
| 161 | Roswell Park Cancer Institute | Buffalo | New York | United States | 14263 |
| 162 | Memorial Sloan Kettering Commack | Commack | New York | United States | 11725 |
| 163 | Arnot Ogden Medical Center/Falck Cancer Center | Elmira | New York | United States | 14905 |
| 164 | Memorial Sloan Kettering Westchester | Harrison | New York | United States | 10604 |
| 165 | Northwell Health/Center for Advanced Medicine | Lake Success | New York | United States | 11042 |
| 166 | Lenox Hill Hospital | New York | New York | United States | 10021 |
| 167 | NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center | New York | New York | United States | 10032 |
| 168 | Memorial Sloan Kettering Cancer Center | New York | New York | United States | 10065 |
| 169 | University of Rochester | Rochester | New York | United States | 14642 |
| 170 | Staten Island University Hospital | Staten Island | New York | United States | 10305 |
| 171 | State University of New York Upstate Medical University | Syracuse | New York | United States | 13210 |
| 172 | Memorial Sloan Kettering Nassau | Uniondale | New York | United States | 11553 |
| 173 | Carolinas Medical Center/Levine Cancer Institute | Charlotte | North Carolina | United States | 28203 |
| 174 | Atrium Health Pineville/LCI-Pineville | Charlotte | North Carolina | United States | 28210 |
| 175 | Atrium Health University City/LCI-University | Charlotte | North Carolina | United States | 28262 |
| 176 | Atrium Health Cabarrus/LCI-Concord | Concord | North Carolina | United States | 28025 |
| 177 | Atrium Health Union/LCI-Union | Monroe | North Carolina | United States | 28112 |
| 178 | Atrium Health Cleveland/LCI-Cleveland | Shelby | North Carolina | United States | 28150 |
| 179 | Sanford Bismarck Medical Center | Bismarck | North Dakota | United States | 58501 |
| 180 | Sanford Roger Maris Cancer Center | Fargo | North Dakota | United States | 58122 |
| 181 | Summa Health System - Akron Campus | Akron | Ohio | United States | 44304 |
| 182 | Cleveland Clinic Akron General | Akron | Ohio | United States | 44307 |
| 183 | Geauga Hospital | Chardon | Ohio | United States | 44024 |
| 184 | Adena Regional Medical Center | Chillicothe | Ohio | United States | 45601 |
| 185 | Case Western Reserve University | Cleveland | Ohio | United States | 44106 |
| 186 | Cleveland Clinic Cancer Center/Fairview Hospital | Cleveland | Ohio | United States | 44111 |
| 187 | Cleveland Clinic Foundation | Cleveland | Ohio | United States | 44195 |
| 188 | Ohio State University Comprehensive Cancer Center | Columbus | Ohio | United States | 43210 |
| 189 | Mount Carmel Health Center West | Columbus | Ohio | United States | 43222 |
| 190 | Dayton Physician LLC-Miami Valley Hospital North | Dayton | Ohio | United States | 45415 |
| 191 | Mercy Cancer Center-Elyria | Elyria | Ohio | United States | 44035 |
| 192 | Cleveland Clinic Cancer Center Independence | Independence | Ohio | United States | 44131 |
| 193 | UH Seidman Cancer Center at Lake Health Mentor Campus | Mentor | Ohio | United States | 44060 |
| 194 | UH Seidman Cancer Center at Southwest General Hospital | Middleburg Heights | Ohio | United States | 44130 |
| 195 | University Hospitals Parma Medical Center | Parma | Ohio | United States | 44129 |
| 196 | Cleveland Clinic Cancer Center Strongsville | Strongsville | Ohio | United States | 44136 |
| 197 | UHHS-Westlake Medical Center | Westlake | Ohio | United States | 44145 |
| 198 | Cleveland Clinic Wooster Family Health and Surgery Center | Wooster | Ohio | United States | 44691 |
| 199 | University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | United States | 73104 |
| 200 | Legacy Mount Hood Medical Center | Gresham | Oregon | United States | 97030 |
| 201 | Legacy Good Samaritan Hospital and Medical Center | Portland | Oregon | United States | 97210 |
| 202 | Jefferson Abington Hospital | Abington | Pennsylvania | United States | 19001 |
| 203 | Crozer-Keystone Regional Cancer Center at Broomall | Broomall | Pennsylvania | United States | 19008 |
| 204 | Bryn Mawr Hospital | Bryn Mawr | Pennsylvania | United States | 19010 |
| 205 | Christiana Care Health System-Concord Health Center | Chadds Ford | Pennsylvania | United States | 19317 |
| 206 | Geisinger Medical Center | Danville | Pennsylvania | United States | 17822 |
| 207 | Northeast Radiation Oncology Center | Dunmore | Pennsylvania | United States | 18512 |
| 208 | Adams Cancer Center | Gettysburg | Pennsylvania | United States | 17325 |
| 209 | Crozer Regional Cancer Center at Brinton Lake | Glen Mills | Pennsylvania | United States | 19342 |
| 210 | Geisinger Medical Oncology-Lewisburg | Lewisburg | Pennsylvania | United States | 17837 |
| 211 | Riddle Memorial Hospital | Media | Pennsylvania | United States | 19063 |
| 212 | Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | United States | 19107 |
| 213 | Fox Chase Cancer Center | Philadelphia | Pennsylvania | United States | 19111 |
| 214 | Jefferson Torresdale Hospital | Philadelphia | Pennsylvania | United States | 19114 |
| 215 | Temple University Hospital | Philadelphia | Pennsylvania | United States | 19140 |
| 216 | Penn State Health Saint Joseph Medical Center | Reading | Pennsylvania | United States | 19605 |
| 217 | Reading Hospital | West Reading | Pennsylvania | United States | 19611 |
| 218 | Geisinger Wyoming Valley/Henry Cancer Center | Wilkes-Barre | Pennsylvania | United States | 18711 |
| 219 | Lankenau Medical Center | Wynnewood | Pennsylvania | United States | 19096 |
| 220 | WellSpan Health-York Cancer Center | York | Pennsylvania | United States | 17403 |
| 221 | AnMed Health Cancer Center | Anderson | South Carolina | United States | 29621 |
| 222 | Prisma Health Cancer Institute - Spartanburg | Boiling Springs | South Carolina | United States | 29316 |
| 223 | Prisma Health Cancer Institute - Faris | Greenville | South Carolina | United States | 29605 |
| 224 | Prisma Health Cancer Institute - Eastside | Greenville | South Carolina | United States | 29615 |
| 225 | Self Regional Healthcare | Greenwood | South Carolina | United States | 29646 |
| 226 | The Radiation Oncology Center-Hilton Head/Bluffton | Hilton Head Island | South Carolina | United States | 29926 |
| 227 | Lancaster Radiation Therapy Center | Lancaster | South Carolina | United States | 29720 |
| 228 | Rock Hill Radiation Therapy Center | Rock Hill | South Carolina | United States | 29730 |
| 229 | Rapid City Regional Hospital | Rapid City | South Dakota | United States | 57701 |
| 230 | Sanford USD Medical Center - Sioux Falls | Sioux Falls | South Dakota | United States | 57117-5134 |
| 231 | Thompson Cancer Survival Center | Knoxville | Tennessee | United States | 37916 |
| 232 | Blount Memorial Hospital | Maryville | Tennessee | United States | 37804 |
| 233 | Vanderbilt University/Ingram Cancer Center | Nashville | Tennessee | United States | 37232 |
| 234 | University of Texas Medical Branch | Galveston | Texas | United States | 77555-0565 |
| 235 | M D Anderson Cancer Center | Houston | Texas | United States | 77030 |
| 236 | UTMB Cancer Center at Victory Lakes | League City | Texas | United States | 77573 |
| 237 | Ogden Regional Medical Center | Ogden | Utah | United States | 84405 |
| 238 | Huntsman Cancer Institute/University of Utah | Salt Lake City | Utah | United States | 84112 |
| 239 | Central Vermont Medical Center/National Life Cancer Treatment | Berlin | Vermont | United States | 05602 |
| 240 | University of Vermont Medical Center | Burlington | Vermont | United States | 05401 |
| 241 | Norris Cotton Cancer Center-North | Saint Johnsbury | Vermont | United States | 05819 |
| 242 | Virginia Commonwealth University/Massey Cancer Center | Richmond | Virginia | United States | 23298 |
| 243 | West Virginia University Healthcare | Morgantown | West Virginia | United States | 26506 |
| 244 | Wheeling Hospital/Schiffler Cancer Center | Wheeling | West Virginia | United States | 26003 |
| 245 | Langlade Hospital and Cancer Center | Antigo | Wisconsin | United States | 54409 |
| 246 | Ascension Southeast Wisconsin Hospital - Elmbrook Campus | Brookfield | Wisconsin | United States | 53045 |
| 247 | Mayo Clinic Health System-Eau Claire Clinic | Eau Claire | Wisconsin | United States | 54701 |
| 248 | Mayo Clinic Health System Eau Claire Hospital-Luther Campus | Eau Claire | Wisconsin | United States | 54703 |
| 249 | Ascension Saint Francis - Reiman Cancer Center | Franklin | Wisconsin | United States | 53132 |
| 250 | Aurora Cancer Care-Grafton | Grafton | Wisconsin | United States | 53024 |
| 251 | Aurora BayCare Medical Center | Green Bay | Wisconsin | United States | 54311 |
| 252 | UW Cancer Center Johnson Creek | Johnson Creek | Wisconsin | United States | 53038 |
| 253 | Aurora Cancer Care-Kenosha South | Kenosha | Wisconsin | United States | 53142 |
| 254 | Gundersen Lutheran Medical Center | La Crosse | Wisconsin | United States | 54601 |
| 255 | Mayo Clinic Health System-Franciscan Healthcare | La Crosse | Wisconsin | United States | 54601 |
| 256 | University of Wisconsin Hospital and Clinics | Madison | Wisconsin | United States | 53792 |
| 257 | Froedtert Menomonee Falls Hospital | Menomonee Falls | Wisconsin | United States | 53051 |
| 258 | Aurora Saint Luke's Medical Center | Milwaukee | Wisconsin | United States | 53215 |
| 259 | Medical College of Wisconsin | Milwaukee | Wisconsin | United States | 53226 |
| 260 | Aurora Sinai Medical Center | Milwaukee | Wisconsin | United States | 53233 |
| 261 | Vince Lombardi Cancer Clinic - Oshkosh | Oshkosh | Wisconsin | United States | 54904 |
| 262 | Ascension All Saints Hospital | Racine | Wisconsin | United States | 53405 |
| 263 | Marshfield Clinic Stevens Point Center | Stevens Point | Wisconsin | United States | 54482 |
| 264 | Aurora Medical Center in Summit | Summit | Wisconsin | United States | 53066 |
| 265 | Vince Lombardi Cancer Clinic-Two Rivers | Two Rivers | Wisconsin | United States | 54241 |
| 266 | Aspirus Regional Cancer Center | Wausau | Wisconsin | United States | 54401 |
| 267 | Aurora West Allis Medical Center | West Allis | Wisconsin | United States | 53227 |
| 268 | Diagnostic and Treatment Center | Weston | Wisconsin | United States | 54476 |
| 269 | Marshfield Medical Center - Weston | Weston | Wisconsin | United States | 54476 |
| 270 | Aspirus Cancer Care - Wisconsin Rapids | Wisconsin Rapids | Wisconsin | United States | 54494 |
| 271 | Kingston Health Sciences Centre | Kingston | Ontario | Canada | K7L 2V7 |
| 272 | London Regional Cancer Program | London | Ontario | Canada | N6A 4L6 |
| 273 | Stronach Regional Health Centre at Southlake | Newmarket | Ontario | Canada | L3Y 2P9 |
| 274 | Ottawa Hospital and Cancer Center-General Campus | Ottawa | Ontario | Canada | K1H 8L6 |
| 275 | University Health Network-Princess Margaret Hospital | Toronto | Ontario | Canada | M5G 2M9 |
| 276 | CHUM - Hopital Notre-Dame | Montreal | Quebec | Canada | H2L 4M1 |
| 277 | McGill University Department of Oncology | Montreal | Quebec | Canada | H2W 1S6 |
| 278 | CHUM - Centre Hospitalier de l'Universite de Montreal | Montreal | Quebec | Canada | H2X 3E4 |
| 279 | The Research Institute of the McGill University Health Centre (MUHC) | Montreal | Quebec | Canada | H3H 2R9 |
| 280 | CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ) | Quebec City | Quebec | Canada | G1R 2J6 |
| 281 | Centre Hospitalier Universitaire de Sherbrooke-Fleurimont | Sherbrooke | Quebec | Canada | J1H 5N4 |
| 282 | Allan Blair Cancer Centre | Regina | Saskatchewan | Canada | S4T 7T1 |
| 283 | Saskatoon Cancer Centre | Saskatoon | Saskatchewan | Canada | S7N 4H4 |
Sponsors and Collaborators
- NRG Oncology
- National Cancer Institute (NCI)
- Radiation Therapy Oncology Group
Investigators
- Principal Investigator: Vinai Gondi, NRG Oncology
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NRG-CC003
- NCI-2015-01548
- NRG-CC003
- NRG-CC003
- UG1CA189867