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Trial record 5 of 40 for:    small cell lung ca | Recruiting, Not yet recruiting, Available Studies

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

This study is currently recruiting participants.
Verified June 2016 by NRG Oncology
Sponsor:
ClinicalTrials.gov Identifier:
NCT02635009
First Posted: December 18, 2015
Last Update Posted: June 21, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
National Cancer Institute (NCI)
Radiation Therapy Oncology Group
Information provided by (Responsible Party):
NRG Oncology
  Purpose
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 Intervention Phase
Extensive Stage Small Cell Lung Carcinoma Limited Stage Small Cell Lung Carcinoma Radiation: 3-Dimensional Conformal Radiation Therapy Other: Cognitive Assessment Radiation: Intensity-Modulated Radiation Therapy Other: Laboratory Biomarker Analysis Other: Quality-of-Life Assessment Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Phase II/III Trial of Prophylactic Cranial Irradiation With or Without Hippocampal Avoidance for Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by NRG Oncology:

Primary Outcome Measures:
  • HVLT-R delayed recall deterioration status, defined using the Reliable Change Index (RCI) (Phase III) [ Time Frame: 6 months from start of treatment ]
    Compared using Fisher's exact test at a significance level of 0.05.

  • Intracranial relapse rate (Phase II) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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.


Estimated Enrollment: 304
Study Start Date: December 2015
Estimated Primary Completion Date: April 2022 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • 3-dimensional radiation therapy
  • 3D-CRT
  • Conformal Therapy
  • Radiation Conformal Therapy
Other: Cognitive Assessment
Ancillary studies
Other: Laboratory Biomarker Analysis
Correlative studies
Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment
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:
  • IMRT
  • Intensity Modulated RT
  • Intensity-Modulated Radiotherapy
Other: Laboratory Biomarker Analysis
Correlative studies
Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • 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 as part of response assessment following chemotherapy can be used for this purpose, but the appropriate sequences must be obtained; this sequence cannot be obtained prior to chemotherapy and is mandatory irrespective of randomization to the experimental or control arm of this study
  • 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 within 14 days prior to Step 2 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
  • 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 within 8 weeks prior to initiating chemotherapy or thoracic radiotherapy)
    • MRI of the brain
    • 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
  • Patients must be registered on study no earlier than 1 week and no later than 8 weeks after completing chemotherapy (+/- thoracic radiotherapy)
  • After chemotherapy, patients must be restaged using the same diagnostic work-up as required pre-chemotherapy; repeat PET/CT or bone scan is not required; patients must have:

    • No central nervous system (CNS) metastases
    • 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
  • 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

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
  • 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02635009


  Hide Study Locations
Locations
United States, Arizona
The University of Arizona Medical Center-University Campus Recruiting
Tucson, Arizona, United States, 85724
Contact: Charles C. Hsu    520-694-6629    charles.c.hsu@gmail.com   
Principal Investigator: Charles C. Hsu         
United States, California
Kaiser Permanente Oakland-Broadway Recruiting
Oakland, California, United States, 94611
Contact: Samantha A. Seaward    626-564-3455    samantha.seaward@kp.org   
Principal Investigator: Samantha A. Seaward         
Saint Joseph Hospital - Orange Recruiting
Orange, California, United States, 92868
Contact: Robert B. Ash    714-734-6220    robert.ash@stjoe.org   
Principal Investigator: Robert B. Ash         
Kaiser Permanente-Rancho Cordova Cancer Center Recruiting
Rancho Cordova, California, United States, 95670
Contact: Samantha A. Seaward    626-564-3455    samantha.seaward@kp.org   
Principal Investigator: Samantha A. Seaward         
Sutter Cancer Centers Radiation Oncology Services-Roseville Recruiting
Roseville, California, United States, 95661
Contact: Christopher U. Jones    415-209-2686    bernicl@sutterhealth.org   
Principal Investigator: Christopher U. Jones         
The Permanente Medical Group-Roseville Radiation Oncology Recruiting
Roseville, California, United States, 95678
Contact: Samantha A. Seaward    626-564-3455    samantha.seaward@kp.org   
Principal Investigator: Samantha A. Seaward         
Sutter General Hospital Recruiting
Sacramento, California, United States, 95816
Contact: Christopher U. Jones    415-209-2686    bernicl@sutterhealth.org   
Principal Investigator: Christopher U. Jones         
Kaiser Permanente Medical Center - Santa Clara Recruiting
Santa Clara, California, United States, 95051
Contact: Samantha A. Seaward    626-564-3455    samantha.seaward@kp.org   
Principal Investigator: Samantha A. Seaward         
United States, Colorado
Swedish Medical Center Recruiting
Englewood, Colorado, United States, 80113
Contact: Keren Sturtz    303-777-2663    kgeisen@co-cancerresearch.org   
Principal Investigator: Keren Sturtz         
United States, Connecticut
Saint Vincent's Medical Center Recruiting
Bridgeport, Connecticut, United States, 06606
Contact: Kylie Nelson    203-576-6329    kylie.nelson@stvincents.org   
Principal Investigator: Nicholas A. Blondin         
United States, Delaware
Christiana Care Health System-Christiana Hospital Recruiting
Newark, Delaware, United States, 19718
Contact: Gregory A. Masters    302-733-6227    gmasters@cbg.org   
Principal Investigator: Gregory A. Masters         
United States, Florida
Moffitt Cancer Center Recruiting
Tampa, Florida, United States, 33612
Contact: Bradford A. Perez    800-456-7121    canceranswers@moffitt.org   
Principal Investigator: Bradford A. Perez         
United States, Georgia
Memorial University Medical Center Recruiting
Savannah, Georgia, United States, 31404
Contact: Aaron W. Pederson    912-350-8568    aaronpederson@memorialhealth.com   
Principal Investigator: Aaron W. Pederson         
United States, Hawaii
Queen's Medical Center Recruiting
Honolulu, Hawaii, United States, 96813
Contact: Richard Y. Lee    808-547-6011    rlee@tccoh.com   
Principal Investigator: Richard Y. Lee         
The Cancer Center of Hawaii-Liliha Recruiting
Honolulu, Hawaii, United States, 96817
Contact: Richard Y. Lee    808-547-6011    rlee@tccoh.com   
Principal Investigator: Richard Y. Lee         
United States, Idaho
Saint Alphonsus Cancer Care Center-Boise Recruiting
Boise, Idaho, United States, 83706
Contact: Samir Narayan    734-712-4673    samir.narayan@stjoeshealth.org   
Principal Investigator: Samir Narayan         
Saint Luke's Mountain States Tumor Institute Recruiting
Boise, Idaho, United States, 83712
Contact: Paul G. Montgomery    800-845-4624    montgomp@slhs.org   
Principal Investigator: Paul G. Montgomery         
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Timothy J. Kruser    312-695-1301    cancer@northwestern.edu   
Principal Investigator: Timothy J. Kruser         
Decatur Memorial Hospital Recruiting
Decatur, Illinois, United States, 62526
Contact: James L. Wade    217-876-4740    kcheek@dmhhs.org   
Principal Investigator: James L. Wade         
Crossroads Cancer Center Recruiting
Effingham, Illinois, United States, 62401
Contact: James L. Wade    217-876-4740    kcheek@dmhhs.org   
Principal Investigator: James L. Wade         
Northwestern Medicine Cancer Center Delnor Recruiting
Geneva, Illinois, United States, 60134
Contact: Vinai Gondi    630-315-1918    Claudine.Gamster@CadenceHealth.org   
Principal Investigator: Vinai Gondi         
Loyola University Medical Center Recruiting
Maywood, Illinois, United States, 60153
Contact: Matthew M. Harkenrider    708-226-4357    mharkenrider@lumc.edu   
Principal Investigator: Matthew M. Harkenrider         
OSF Saint Francis Medical Center Recruiting
Peoria, Illinois, United States, 61637
Contact: James L. Wade    217-876-4740    kcheek@dmhhs.org   
Principal Investigator: James L. Wade         
Memorial Medical Center Recruiting
Springfield, Illinois, United States, 62781
Contact: James L. Wade    217-876-4740    kcheek@dmhhs.org   
Principal Investigator: James L. Wade         
Northwestern Medicine Cancer Center Warrenville Recruiting
Warrenville, Illinois, United States, 60555
Contact: Vinai Gondi    630-315-1918    Claudine.Gamster@CadenceHealth.org   
Principal Investigator: Vinai Gondi         
United States, Indiana
Saint Vincent Anderson Regional Hospital/Cancer Center Recruiting
Anderson, Indiana, United States, 46016
Contact: Alexander M. Yeh    765-646-8358    amyeh@stvincent.org   
Principal Investigator: Alexander M. Yeh         
Parkview Hospital Randallia Recruiting
Fort Wayne, Indiana, United States, 46805
Contact: Brian K. Chang    260-373-8888    parkviewresearch@parkview.com   
Principal Investigator: Brian K. Chang         
IU Health Goshen Center for Cancer Care Recruiting
Goshen, Indiana, United States, 46526
Contact: James A. Wheeler    574-535-2858    jwheeler@goshenhealth.com   
Principal Investigator: James A. Wheeler         
United States, Iowa
Iowa Methodist Medical Center Recruiting
Des Moines, Iowa, United States, 50309
Contact: Robert J. Behrens    515-282-2921    rbehrens@cancercenterofiowa.com   
Principal Investigator: Robert J. Behrens         
United States, Kansas
Via Christi Regional Medical Center Recruiting
Wichita, Kansas, United States, 67214
Contact: Shaker R. Dakhil    316-262-4467    shaker.dakhil@cancercenterofkansas.com   
Principal Investigator: Shaker R. Dakhil         
United States, Kentucky
University of Kentucky/Markey Cancer Center Recruiting
Lexington, Kentucky, United States, 40536
Contact: Ronald C. McGarry    859-257-3379    ronald.mcgarry@uky.edu   
Principal Investigator: Ronald C. McGarry         
United States, Maryland
University of Maryland Medical Center Not yet recruiting
Baltimore, Maryland, United States, 21201
Contact: Minesh P. Mehta    410-328-6921    mmehta@umm.edu   
Principal Investigator: Minesh P. Mehta         
University of Maryland/Greenebaum Cancer Center Recruiting
Baltimore, Maryland, United States, 21201
Contact: Steven J. Feigenberg    800-888-8823    sfeigenberg@umm.edu   
Principal Investigator: Steven J. Feigenberg         
Upper Chesapeake Medical Center Recruiting
Bel Air, Maryland, United States, 21014
Contact: Mark V. Mishra    800-888-8823    mmishra@umm.edu   
Principal Investigator: Mark V. Mishra         
United States, Massachusetts
Lahey Hospital and Medical Center Recruiting
Burlington, Massachusetts, United States, 01805
Contact: Klaudia U. Hunter    978-788-7084    ghincks@lowellgeneral.org   
Principal Investigator: Klaudia U. Hunter         
Lowell General Hospital Recruiting
Lowell, Massachusetts, United States, 01854
Contact: Matthew S. Katz    978-788-7084    ghincks@lowellgeneral.org   
Principal Investigator: Matthew S. Katz         
United States, Michigan
Saint Joseph Mercy Hospital Recruiting
Ann Arbor, Michigan, United States, 48106-0995
Contact: Samir Narayan    734-712-4673    samir.narayan@stjoeshealth.org   
Principal Investigator: Samir Narayan         
21st Century Oncology-Clarkston Recruiting
Clarkston, Michigan, United States, 48346
Contact: Frank A. Vicini    888-326-9729      
Principal Investigator: Frank A. Vicini         
Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48202
Contact: Eleanor M. Walker    313-916-1784    ewalker1@hfhs.org   
Principal Investigator: Eleanor M. Walker         
21st Century Oncology-Farmington Hills Recruiting
Farmington Hills, Michigan, United States, 48334
Contact: Frank A. Vicini    888-326-9729      
Principal Investigator: Frank A. Vicini         
McLaren Cancer Institute-Flint Recruiting
Flint, Michigan, United States, 48532
Contact: Kiran Devisetty    989-667-6257      
Principal Investigator: Kiran Devisetty         
McLaren Cancer Institute-Northern Michigan Recruiting
Petoskey, Michigan, United States, 49770
Contact: Kiran Devisetty    989-667-6257      
Principal Investigator: Kiran Devisetty         
Lakeland Hospital Recruiting
St. Joseph, Michigan, United States, 49085
Contact: Kathleen J. Yost    616-391-1230    connie.szczepanek@grcop.org   
Principal Investigator: Kathleen J. Yost         
21st Century Oncology-Troy Recruiting
Troy, Michigan, United States, 48098
Contact: Frank A. Vicini    888-326-9729      
Principal Investigator: Frank A. Vicini         
Henry Ford Medical Center - West Bloomfield Recruiting
West Bloomfield, Michigan, United States, 48322
Contact: Eleanor M. Walker    313-916-1784    ewalker1@hfhs.org   
Principal Investigator: Eleanor M. Walker         
United States, Minnesota
Saint Luke's Hospital of Duluth Recruiting
Duluth, Minnesota, United States, 55805
Contact: Steven R. Bonin    218-249-7825    kdean@slhduluth.com   
Principal Investigator: Steven R. Bonin         
United States, Missouri
Barnes-Jewish West County Hospital Recruiting
Creve Coeur, Missouri, United States, 63141
Contact: Clifford G. Robinson    800-600-3606    info@siteman.wustl.edu   
Principal Investigator: Clifford G. Robinson         
Saint Luke's Hospital of Kansas City Recruiting
Kansas City, Missouri, United States, 64111
Contact: Rakesh Gaur    816-932-2677    SLCIResearch1@saint-lukes.org   
Principal Investigator: Rakesh Gaur         
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Clifford G. Robinson    800-600-3606    info@siteman.wustl.edu   
Principal Investigator: Clifford G. Robinson         
Missouri Baptist Medical Center Recruiting
Saint Louis, Missouri, United States, 63131
Contact: James L. Wade    217-876-4740    kcheek@dmhhs.org   
Principal Investigator: James L. Wade         
United States, Montana
Billings Clinic Cancer Center Recruiting
Billings, Montana, United States, 59101
Contact: Benjamin T. Marchello    800-648-6274    bmarchello@mtcancer.org   
Principal Investigator: Benjamin T. Marchello         
Benefis Healthcare- Sletten Cancer Institute Recruiting
Great Falls, Montana, United States, 59405
Contact: Benjamin T. Marchello    800-648-6274    bmarchello@mtcancer.org   
Principal Investigator: Benjamin T. Marchello         
United States, New Hampshire
Dartmouth Hitchcock Medical Center Recruiting
Lebanon, New Hampshire, United States, 03756
Contact: Gregory A. Russo    800-639-6918    cancer.research.nurse@dartmouth.edu   
Principal Investigator: Gregory A. Russo         
United States, New York
Montefiore Medical Center - Moses Campus Recruiting
Bronx, New York, United States, 10467-2490
Contact: William R. Bodner    718-904-2730    aecc@aecom.yu.edu   
Principal Investigator: William R. Bodner         
The New York Methodist Hospital Recruiting
Brooklyn, New York, United States, 11215
Contact: Sameer Rafla-Demetrious    718-780-3637    srafla@verizon.net   
Principal Investigator: Sameer Rafla-Demetrious         
Arnot Ogden Medical Center/Falck Cancer Center Recruiting
Elmira, New York, United States, 14905
Contact: Chi K. Tsang    607-271-7000    chiktsang@gmail.com   
Principal Investigator: Chi K. Tsang         
North Shore-LIJ Health System/Center for Advanced Medicine Recruiting
New Hyde Park, New York, United States, 11040
Contact: Rajiv Sharma    516-734-8954    rsharma12@nshs.edu   
Principal Investigator: Rajiv Sharma         
Lenox Hill Hospital Recruiting
New York, New York, United States, 10021
Contact: Rajiv Sharma    516-734-8954    rsharma12@nshs.edu   
Principal Investigator: Rajiv Sharma         
University of Rochester Recruiting
Rochester, New York, United States, 14642
Contact: Yuhchyau Chen    585-275-5830    yuhchyau_chen@urmc.rochester.edu   
Principal Investigator: Yuhchyau Chen         
United States, Ohio
Akron General Medical Center Recruiting
Akron, Ohio, United States, 44307
Contact: Mitchel L. Fromm    330-344-6348    mitchel.fromm@akrongeneral.org   
Principal Investigator: Mitchel L. Fromm         
Case Western Reserve University Recruiting
Cleveland, Ohio, United States, 44106
Contact: Mitchell Machtay    800-641-2422    mitchell.machtay@uhhospitals.org   
Principal Investigator: Mitchell Machtay         
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Contact: Gregory M. M. Videtic    866-223-8100    videtig@ccf.org   
Principal Investigator: Gregory M. M. Videtic         
Ohio State University Comprehensive Cancer Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Karl E. Haglund    800-293-5066    Jamesline@osumc.edu   
Principal Investigator: Karl E. Haglund         
Southwest General Health Center Ireland Cancer Center Recruiting
Middleburg Heights, Ohio, United States, 44130
Contact: Mitchell Machtay    800-641-2422    mitchell.machtay@uhhospitals.org   
Principal Investigator: Mitchell Machtay         
University Hospitals Parma Medical Center Recruiting
Parma, Ohio, United States, 44129
Contact: Mitchell Machtay    800-641-2422    mitchell.machtay@uhhospitals.org   
Principal Investigator: Mitchell Machtay         
UHHS-Westlake Medical Center Recruiting
Westlake, Ohio, United States, 44145
Contact: Mitchell Machtay    800-641-2422    mitchell.machtay@uhhospitals.org   
Principal Investigator: Mitchell Machtay         
United States, Oregon
Legacy Good Samaritan Hospital and Medical Center Recruiting
Portland, Oregon, United States, 97210
Contact: Andrew Y. Kee    503-413-8363    cancer@lhs.org   
Principal Investigator: Andrew Y. Kee         
United States, Pennsylvania
Abington Memorial Hospital Recruiting
Abington, Pennsylvania, United States, 19001
Contact: Wayne H. Pinover    215-481-2402    wpinover@amh.org   
Principal Investigator: Wayne H. Pinover         
Bryn Mawr Hospital Recruiting
Bryn Mawr, Pennsylvania, United States, 19010
Contact: Albert S. DeNittis    484-476-2649    ewend@mlhs.org   
Principal Investigator: Albert S. DeNittis         
Adams Cancer Center Recruiting
Gettysburg, Pennsylvania, United States, 17325
Contact: Amit B. Shah    877-441-7957    ashah@wellspan.org   
Principal Investigator: Amit B. Shah         
Thomas Jefferson University Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Wenyin Shi    215-955-6084    wenyin.shi@jefferson.edu   
Principal Investigator: Wenyin Shi         
Reading Hospital Recruiting
West Reading, Pennsylvania, United States, 19611
Contact: Terrence P. Cescon    610-988-9323    terrence.cescon@readinghealth.org   
Principal Investigator: Terrence P. Cescon         
Lankenau Medical Center Recruiting
Wynnewood, Pennsylvania, United States, 19096
Contact: Albert S. DeNittis    484-476-2649    ewend@mlhs.org   
Principal Investigator: Albert S. DeNittis         
WellSpan Health-York Cancer Center Recruiting
York, Pennsylvania, United States, 17403
Contact: Amit B. Shah    877-441-7957    ashah@wellspan.org   
Principal Investigator: Amit B. Shah         
United States, South Carolina
AnMed Health Cancer Center Recruiting
Anderson, South Carolina, United States, 29621
Contact: Leander I. Cannick    864-512-1000    leander.cannick@anmedhealth.org   
Principal Investigator: Leander I. Cannick         
Greenville Health System Cancer Institute-Faris Recruiting
Greenville, South Carolina, United States, 29605
Contact: David L. Grisell    864-241-6251    dgrisell@ghs.org   
Principal Investigator: David L. Grisell         
Greenville Health System Cancer Institute-Eastside Recruiting
Greenville, South Carolina, United States, 29615
Contact: David L. Grisell    864-241-6251    dgrisell@ghs.org   
Principal Investigator: David L. Grisell         
Self Regional Healthcare Recruiting
Greenwood, South Carolina, United States, 29646
Contact: David T. Marshall    843-792-9321    marshadt@musc.edu   
Principal Investigator: David T. Marshall         
Greenville Health System Cancer Institute-Spartanburg Recruiting
Spartanburg, South Carolina, United States, 29307
Contact: David L. Grisell    864-241-6251    dgrisell@ghs.org   
Principal Investigator: David L. Grisell         
United States, South Dakota
Rapid City Regional Hospital Recruiting
Rapid City, South Dakota, United States, 57701
Contact: Michael J. Swartz    605-716-3982    research@rcrh.org   
Principal Investigator: Michael J. Swartz         
Sanford USD Medical Center - Sioux Falls Recruiting
Sioux Falls, South Dakota, United States, 57117-5134
Contact: Preston D. Steen    701-234-6161    preston.steen@sanfordhealth.org   
Principal Investigator: Preston D. Steen         
United States, Tennessee
Thompson Cancer Survival Center Recruiting
Knoxville, Tennessee, United States, 37916
Contact: Grant M. Clark    865-541-1162    gclark1@covhlth.com   
Principal Investigator: Grant M. Clark         
United States, Texas
University of Texas Medical Branch Recruiting
Galveston, Texas, United States, 77555-0565
Contact: Todd A. Swanson    409-772-1950    clinical.research@utmb.edu   
Principal Investigator: Todd A. Swanson         
UTMB Cancer Center at Victory Lakes Recruiting
League City, Texas, United States, 77573
Contact: Todd A. Swanson    409-772-1950    clinical.research@utmb.edu   
Principal Investigator: Todd A. Swanson         
United States, Vermont
University of Vermont Medical Center Recruiting
Burlington, Vermont, United States, 05401
Contact: Christopher J. Anker    802-656-4101    chris.anker@uvmhealth.org   
Principal Investigator: Christopher J. Anker         
United States, Virginia
Virginia Commonwealth University/Massey Cancer Center Recruiting
Richmond, Virginia, United States, 23298
Contact: Timothy J. Harris    804-628-1939    timothy.harris@vcuhealth.org   
Principal Investigator: Timothy J. Harris         
United States, West Virginia
West Virginia University Healthcare Recruiting
Morgantown, West Virginia, United States, 26506
Contact: Malcolm D. Mattes    304-293-2745    sfilburn@hsc.wvu.edu   
Principal Investigator: Malcolm D. Mattes         
Wheeling Hospital/Schiffler Cancer Center Recruiting
Wheeling, West Virginia, United States, 26003
Contact: Jondavid Pollock    304-243-5047    jpollock@wheelinghospital.org   
Principal Investigator: Jondavid Pollock         
United States, Wisconsin
University of Wisconsin Hospital and Clinics Recruiting
Madison, Wisconsin, United States, 53792
Contact: Andrew M. Baschnagel    715-422-7718    baschnagel@humonc.wisc.edu   
Principal Investigator: Andrew M. Baschnagel         
Wheaton Franciscan Cancer Care - All Saints Recruiting
Racine, Wisconsin, United States, 53405
Contact: James H. Taylor    262-785-2273    james.taylor@wfhc.org   
Principal Investigator: James H. Taylor         
Aspirus UW Cancer Center Recruiting
Wisconsin Rapids, Wisconsin, United States, 54494
Contact: Andrew M. Baschnagel    715-422-7718    baschnagel@humonc.wisc.edu   
Principal Investigator: Andrew M. Baschnagel         
Canada, Quebec
CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ) Recruiting
Quebec City, Quebec, Canada, G1R 2J6
Contact: Anne Dagnault    418-525-4444    rechclinique@crchuq.ulaval.ca   
Principal Investigator: Anne Dagnault         
Sponsors and Collaborators
NRG Oncology
National Cancer Institute (NCI)
Radiation Therapy Oncology Group
Investigators
Principal Investigator: Vinai Gondi NRG Oncology
  More Information

Responsible Party: NRG Oncology
ClinicalTrials.gov Identifier: NCT02635009     History of Changes
Other Study ID Numbers: NRG-CC003
NCI-2015-01548 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
NRG-CC003 ( Other Identifier: NRG Oncology )
NRG-CC003 ( Other Identifier: DCP )
UG1CA189867 ( U.S. NIH Grant/Contract )
First Submitted: December 16, 2015
First Posted: December 18, 2015
Last Update Posted: June 21, 2016
Last Verified: June 2016

Additional relevant MeSH terms:
Small Cell Lung Carcinoma
Lung Neoplasms
Lung Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Respiratory Tract Diseases