Veliparib With or Without Radiation Therapy, Carboplatin, and Paclitaxel in Patients With Stage III Non-small Cell Lung Cancer That Cannot Be Removed by Surgery
NCT ID: NCT01386385
Last Updated: 2025-11-14
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
53 participants
INTERVENTIONAL
2011-06-20
2025-12-31
Brief Summary
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Detailed Description
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I. To establish the maximum tolerated dose (MTD) and the recommended phase II dose of ABT-888 (veliparib) when given concurrently with standard carboplatin/paclitaxel and radiotherapy in patients with unresectable stage III non-small cell lung cancer (NSCLC). (Phase I) II. To assess whether carboplatin/paclitaxel plus ABT-888 compared with carboplatin/paclitaxel plus placebo improves progression-free survival (PFS) in patients with unresectable stage III NSCLC. (Phase II) III. To compare overall survival (OS) in patients treated with carboplatin/paclitaxel and radiotherapy plus ABT-888 to those treated with carboplatin, paclitaxel and radiotherapy plus placebo. (Phase II) IV. To assess the response rate (confirmed and unconfirmed, complete and partial responses) and disease control rate in the subset of patients with measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) criteria. (Phase II) V. To assess the safety and toxicity profile of the regimen. (Phase II)
SECONDARY OBJECTIVES:
I. To collect tumor tissue from pretreatment biopsies (archival samples) for biomarker studies, including poly (ADP-ribose) polymerase 1 (PARP) activity by measuring the levels of poly-ADP-ribose, gamma-H2A histone family, member X (gamma-H2AX), and messenger ribonucleic acid (mRNA) expression levels of deoxyribonucleic acid (DNA) repair enzymes such as excision repair cross-complementing rodent repair deficiency, complementation group 1 (ERCC1)/x-ray repair complementing defective repair in Chinese hamster cells 1 (XRCC1).
II. To collect blood samples for evaluation of gamma-H2AX (circulating tumor cells) and other relevant future studies.
OUTLINE: This is a phase I, dose-escalation study of veliparib followed by a randomized phase II study.
PHASE I:
INDUCTION THERAPY: Patients undergo 3-dimensional conformal radiation therapy (3D-CRT) once daily (QD), 5 days a week, for 6 weeks. Patients also receive veliparib orally (PO) twice daily (BID) on days 1-43 and carboplatin intravenously (IV) over 30 minutes and paclitaxel IV over 1 hour on days 1, 8, 15, 22, 36, and 43 in the absence of disease progression or unacceptable toxicity. Patients without disease progression after completion of chemoradiotherapy undergo consolidation therapy.
CONSOLIDATION THERAPY: Beginning within 4-6 weeks of chemotherapy and radiation therapy, patients receive veliparib PO BID on days 1-7 (course 1) and 22-28 (course 2) and carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1 and on day 22 of course 2. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
PHASE II: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients undergo 3D-CRT and receive veliparib, carboplatin, and paclitaxel as in Phase I induction and consolidation therapy.
ARM II: Patients undergo 3D-CRT as in arm I. Patients also receive placebo PO BID on days 1-43 and carboplatin and paclitaxel as in Phase I. Within 4-6 weeks after completion of chemotherapy and radiation therapy, patients receive placebo on days 1-7 and carboplatin and paclitaxel as in Phase I.
After completion of study treatment, patients are followed up every 4 months for first 2 years and then every 6 months until 5 years.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Arm I (RT, veliparib, carboplatin, paclitaxel)
Patients undergo 3D-CRT and receive veliparib, carboplatin, and paclitaxel as in Phase I induction and consolidation therapy.
3-Dimensional Conformal Radiation Therapy
Undergo 3D-conformal RT
Carboplatin
Given IV
Laboratory Biomarker Analysis
Correlative studies
Paclitaxel
Given IV
Veliparib
Given PO
Arm II (3D-CRT, placebo, carboplatin, paclitaxel)
Patients undergo 3D-CRT as in arm I. Patients also receive placebo PO BID on days 1-43 and carboplatin and paclitaxel as in Phase I. Within 4-6 weeks after completion of chemotherapy and radiation therapy, patients receive placebo on days 1-7 and carboplatin and paclitaxel as in Phase I.
3-Dimensional Conformal Radiation Therapy
Undergo 3D-conformal RT
Carboplatin
Given IV
Laboratory Biomarker Analysis
Correlative studies
Paclitaxel
Given IV
Placebo Administration
Given PO
Interventions
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3-Dimensional Conformal Radiation Therapy
Undergo 3D-conformal RT
Carboplatin
Given IV
Laboratory Biomarker Analysis
Correlative studies
Paclitaxel
Given IV
Placebo Administration
Given PO
Veliparib
Given PO
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Per the American Joint Committee on Cancer (AJCC) 7th edition, pleural and pericardial are now considered stage M1a disease; when pleural fluid is visible on the computed tomography (CT) scan or on a chest x-ray, a thoracentesis is required to confirm that the pleural fluid is cytologically negative; patients with exudative pleural effusions are excluded, regardless of cytology; patients with effusions that are minimal (i.e. not visible on chest x-ray) that are too small to safely tap are eligible; a small effusion that has positive fludeoxyglucose F 18 (FDG) uptake on positron emission tomography (PET) has to be proven to be malignant per standard of care diagnostic procedures for the patient to be excluded
* Patients must have measurable or non-measurable disease documented by CT, magnetic resonance imaging (MRI) or PET/CT; the CT from a combined PET/CT may be used to document only non-measurable disease unless the scan is of diagnostic quality; measurable disease must be assessed by CT within 28 days prior to registration; pleural effusions, ascites and laboratory parameters are not acceptable as the only evidence of disease; non-measurable disease must be assessed within 42 days prior to registration; all disease must be assessed and documented on the Baseline Tumor Assessment Form
* Patients with brain metastases are ineligible; all patients must have a pretreatment CT or MRI scan of the brain to evaluate for central nervous system (CNS) disease within 42 days prior to registration
* Patients must not have received any prior systemic therapy (chemotherapy or other biologic therapy) for lung cancer
* Patients must not have received prior chest radiation therapy for NSCLC
* Patients must not have had a previous surgical resection; however, patients may have undergone exploratory thoracotomy, mediastinoscopy, excisional biopsy or similar surgery for the purpose of determining the diagnosis, stage or potential resectability of newly diagnosed lung tumor; at least 28 days must have elapsed since thoracic surgery (excluding mediastinoscopy or other minor surgeries) and patients should have recovered from all associated toxicities at the time of registration; patients must not be planning to undergo a minor surgical procedure while on this study
* Patients must have Zubrod performance status 0-1
* Patients must have tumor tissue available for submission to assess gene expression of ERCC1 and XRCC1; patients must also be offered participation in banking for future use of specimens
* Absolute neutrophil count \>= 1,500/mcl
* Platelets \>= 100,000/mcl
* Hemoglobin \>= 9.0 g/dl
* Total bilirubin within institutional upper limit of normal (IULN)
* Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase \[AST\]) or serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase \[ALT\]) =\< 2.5 x IULN
* Patients must not be pregnant or nursing; women/men of reproductive potential must have agreed to use an effective contraceptive method; a woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months; in addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation; however, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures
* Patients must have a serum creatinine =\< the IULN AND measured or calculated creatinine clearance \>= 60 cc/min using the Cockroft-Gault formula
* Patients must have pulmonary function tests (PFTs) including forced expiratory volume in 1 second (FEV1) within 84 days prior to registration; for FEV1, the best value obtained pre- or post-bronchodilator must be \>= 1.2 liters/second and/or \>= 50% predicted
* Patients may not be planning to receive any other investigational agents
* Patients must not have more than 10% weight loss in the past 6 months
* Patients must not have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to ABT-888, carboplatin, paclitaxel or other agents used in study
* No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five years
* Patient must not have any uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* Patients must not currently have a \> grade 1 symptomatic neuropathy-sensory (National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\] version 4.0)
* Patients must not have a history of seizures
* Patients must not have any known immune deficiencies; patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy; therefore, known human immunodeficiency virus (HIV) positive patients receiving combination anti-retroviral therapy are excluded from the study
* Patients must be able to swallow whole capsules
* Prestudy history and physical must be obtained within 28 days prior to registration
* All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
* As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system
* REGISTRATION #2 - PRIOR TO CONSOLIDATION CHEMOTHERAPY:
* REGISTRATION #2 - PRIOR TO CONSOLIDATION CHEMOTHERAPY: Patients must have completed chemoradiotherapy per protocol and at least four weeks but no more than six weeks must have elapsed from the last day of induction therapy (the last day of radiation)
* REGISTRATION #2 - PRIOR TO CONSOLIDATION CHEMOTHERAPY: Patients must have undergone restaging tests according to the study calendar and determined to have no evidence of disease progression
* REGISTRATION #2 - PRIOR TO CONSOLIDATION CHEMOTHERAPY: Patients must have a serum creatinine =\< (IULN) AND measured of calculated creatinine clearance \>= 60 cc/min using the Cockroft-Gault formula
* REGISTRATION #2 - PRIOR TO CONSOLIDATION CHEMOTHERAPY: Absolute neutrophil count \>= 1,500 mcl
* REGISTRATION #2 - PRIOR TO CONSOLIDATION CHEMOTHERAPY: Platelets \>= 100,000/mcl
* REGISTRATION #2 - PRIOR TO CONSOLIDATION CHEMOTHERAPY: Hemoglobin \>= 9.0 g/dl
* REGISTRATION #2 - PRIOR TO CONSOLIDATION CHEMOTHERAPY: Total bilirubin =\< IULN
* REGISTRATION #2 - PRIOR TO CONSOLIDATION CHEMOTHERAPY: SGOT (AST) or SGPT (ALT) =\< 2.5 x IULN
* REGISTRATION #2 - PRIOR TO CONSOLIDATION CHEMOTHERAPY: Patients must have Zubrod performance status 0-1
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Responsible Party
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Principal Investigators
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Athanassios (Ethan) Argiris
Role: PRINCIPAL_INVESTIGATOR
SWOG Cancer Research Network
Locations
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Anchorage Associates in Radiation Medicine
Anchorage, Alaska, United States
Alaska Breast Care and Surgery LLC
Anchorage, Alaska, United States
Alaska Oncology and Hematology LLC
Anchorage, Alaska, United States
Alaska Women's Cancer Care
Anchorage, Alaska, United States
Anchorage Oncology Centre
Anchorage, Alaska, United States
Katmai Oncology Group
Anchorage, Alaska, United States
Providence Alaska Medical Center
Anchorage, Alaska, United States
Banner University Medical Center - Tucson
Tucson, Arizona, United States
University of Arizona Cancer Center-North Campus
Tucson, Arizona, United States
Tower Cancer Research Foundation
Beverly Hills, California, United States
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank, California, United States
City of Hope Corona
Corona, California, United States
City of Hope Comprehensive Cancer Center
Duarte, California, United States
Los Angeles General Medical Center
Los Angeles, California, United States
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States
Mercy Cancer Center
Merced, California, United States
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States
UCHealth University of Colorado Hospital
Aurora, Colorado, United States
Yale University
New Haven, Connecticut, United States
Hawaii Cancer Care Inc - Waterfront Plaza
Honolulu, Hawaii, United States
Queen's Cancer Cenrer - POB I
Honolulu, Hawaii, United States
Queen's Medical Center
Honolulu, Hawaii, United States
Straub Clinic and Hospital
Honolulu, Hawaii, United States
University of Hawaii Cancer Center
Honolulu, Hawaii, United States
Hawaii Cancer Care Inc-Liliha
Honolulu, Hawaii, United States
Queen's Cancer Center - Kuakini
Honolulu, Hawaii, United States
The Cancer Center of Hawaii-Liliha
Honolulu, Hawaii, United States
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, United States
Wilcox Memorial Hospital and Kauai Medical Clinic
Lihue, Hawaii, United States
Pali Momi Medical Center
‘Aiea, Hawaii, United States
Queen's Cancer Center - Pearlridge
‘Aiea, Hawaii, United States
The Cancer Center of Hawaii-Pali Momi
‘Aiea, Hawaii, United States
Saint Luke's Cancer Institute - Boise
Boise, Idaho, United States
Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho, United States
Saint Luke's Cancer Institute - Fruitland
Fruitland, Idaho, United States
Saint Luke's Cancer Institute - Meridian
Meridian, Idaho, United States
Saint Luke's Cancer Institute - Nampa
Nampa, Idaho, United States
Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho, United States
Kootenai Clinic Cancer Services - Sandpoint
Sandpoint, Idaho, United States
Saint Luke's Cancer Institute - Twin Falls
Twin Falls, Idaho, United States
Rush-Copley Medical Center
Aurora, Illinois, United States
OSF Saint Joseph Medical Center
Bloomington, Illinois, United States
Illinois CancerCare-Bloomington
Bloomington, Illinois, United States
Illinois CancerCare-Canton
Canton, Illinois, United States
Memorial Hospital of Carbondale
Carbondale, Illinois, United States
SIH Cancer Institute
Carterville, Illinois, United States
Illinois CancerCare-Carthage
Carthage, Illinois, United States
Centralia Oncology Clinic
Centralia, Illinois, United States
Northwestern University
Chicago, Illinois, United States
Carle at The Riverfront
Danville, Illinois, United States
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, United States
Carle Physician Group-Effingham
Effingham, Illinois, United States
Crossroads Cancer Center
Effingham, Illinois, United States
Illinois CancerCare-Eureka
Eureka, Illinois, United States
Illinois CancerCare-Galesburg
Galesburg, Illinois, United States
Western Illinois Cancer Treatment Center
Galesburg, Illinois, United States
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, United States
Illinois CancerCare-Macomb
Macomb, Illinois, United States
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
SSM Health Good Samaritan
Mount Vernon, Illinois, United States
Cancer Care Center of O'Fallon
O'Fallon, Illinois, United States
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, United States
Illinois CancerCare-Pekin
Pekin, Illinois, United States
OSF Saint Francis Radiation Oncology at Pekin
Pekin, Illinois, United States
Illinois CancerCare-Peoria
Peoria, Illinois, United States
OSF Saint Francis Radiation Oncology at Peoria Cancer Center
Peoria, Illinois, United States
Methodist Medical Center of Illinois
Peoria, Illinois, United States
OSF Saint Francis Medical Center
Peoria, Illinois, United States
Illinois CancerCare-Peru
Peru, Illinois, United States
Valley Radiation Oncology
Peru, Illinois, United States
Illinois CancerCare-Princeton
Princeton, Illinois, United States
Central Illinois Hematology Oncology Center
Springfield, Illinois, United States
Southern Illinois University School of Medicine
Springfield, Illinois, United States
Springfield Clinic
Springfield, Illinois, United States
Springfield Memorial Hospital
Springfield, Illinois, United States
Southwest Illinois Health Services LLP
Swansea, Illinois, United States
Carle Cancer Center
Urbana, Illinois, United States
The Carle Foundation Hospital
Urbana, Illinois, United States
Rush-Copley Healthcare Center
Yorkville, Illinois, United States
Fort Wayne Medical Oncology and Hematology Inc-Parkview
Fort Wayne, Indiana, United States
Reid Health
Richmond, Indiana, United States
McFarland Clinic - Ames
Ames, Iowa, United States
Siouxland Regional Cancer Center
Sioux City, Iowa, United States
Cancer Center of Kansas - Chanute
Chanute, Kansas, United States
Cancer Center of Kansas - Dodge City
Dodge City, Kansas, United States
Cancer Center of Kansas - El Dorado
El Dorado, Kansas, United States
Cancer Center of Kansas - Fort Scott
Fort Scott, Kansas, United States
Saint Catherine Hospital
Garden City, Kansas, United States
Central Care Cancer Center - Great Bend
Great Bend, Kansas, United States
HaysMed
Hays, Kansas, United States
Cancer Center of Kansas-Independence
Independence, Kansas, United States
University of Kansas Cancer Center-West
Kansas City, Kansas, United States
University of Kansas Cancer Center
Kansas City, Kansas, United States
Cancer Center of Kansas-Kingman
Kingman, Kansas, United States
Lawrence Memorial Hospital
Lawrence, Kansas, United States
Cancer Center of Kansas-Liberal
Liberal, Kansas, United States
Cancer Center of Kansas-Manhattan
Manhattan, Kansas, United States
Cancer Center of Kansas - McPherson
McPherson, Kansas, United States
Cancer Center of Kansas - Newton
Newton, Kansas, United States
The University of Kansas Cancer Center - Olathe
Olathe, Kansas, United States
University of Kansas Cancer Center-Overland Park
Overland Park, Kansas, United States
Cancer Center of Kansas - Parsons
Parsons, Kansas, United States
Mercy Hospital Pittsburg
Pittsburg, Kansas, United States
Cancer Center of Kansas - Pratt
Pratt, Kansas, United States
Cancer Center of Kansas - Salina
Salina, Kansas, United States
Salina Regional Health Center
Salina, Kansas, United States
University of Kansas Health System Saint Francis Campus
Topeka, Kansas, United States
Cancer Center of Kansas - Wellington
Wellington, Kansas, United States
University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas, United States
Associates In Womens Health
Wichita, Kansas, United States
Cancer Center of Kansas-Wichita Medical Arts Tower
Wichita, Kansas, United States
Ascension Via Christi Hospitals Wichita
Wichita, Kansas, United States
Cancer Center of Kansas - Wichita
Wichita, Kansas, United States
Wesley Medical Center
Wichita, Kansas, United States
Cancer Center of Kansas - Winfield
Winfield, Kansas, United States
Lahey Hospital and Medical Center
Burlington, Massachusetts, United States
Bronson Battle Creek
Battle Creek, Michigan, United States
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, United States
Henry Ford Hospital
Detroit, Michigan, United States
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids, Michigan, United States
Trinity Health Grand Rapids Hospital
Grand Rapids, Michigan, United States
West Michigan Cancer Center
Kalamazoo, Michigan, United States
Trinity Health Muskegon Hospital
Muskegon, Michigan, United States
Corewell Health Lakeland Hospitals - Niles Hospital
Niles, Michigan, United States
Corewell Health Reed City Hospital
Reed City, Michigan, United States
Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
Saint Joseph, Michigan, United States
Corewell Health Lakeland Hospitals - Saint Joseph Hospital
Saint Joseph, Michigan, United States
Munson Medical Center
Traverse City, Michigan, United States
University of Michigan Health - West
Wyoming, Michigan, United States
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota, United States
Baptist Memorial Hospital and Cancer Center-Desoto
Southhaven, Mississippi, United States
Mercy Oncology and Hematology - Clayton-Clarkson
Ballwin, Missouri, United States
Parkland Health Center-Bonne Terre
Bonne Terre, Missouri, United States
Mercy Cancer Center - Cape Girardeau
Cape Girardeau, Missouri, United States
Saint Francis Medical Center
Cape Girardeau, Missouri, United States
MU Health Care Goldschmidt Cancer Center
Jefferson City, Missouri, United States
Freeman Health System
Joplin, Missouri, United States
Mercy Hospital Joplin
Joplin, Missouri, United States
University Health Truman Medical Center
Kansas City, Missouri, United States
Kansas City Veterans Affairs Medical Center
Kansas City, Missouri, United States
The University of Kansas Cancer Center-South
Kansas City, Missouri, United States
University of Kansas Cancer Center - North
Kansas City, Missouri, United States
University of Kansas Cancer Center - Lee's Summit
Lee's Summit, Missouri, United States
Phelps Health Delbert Day Cancer Institute
Rolla, Missouri, United States
Sainte Genevieve County Memorial Hospital
Sainte Genevieve, Missouri, United States
Mercy Hospital Springfield
Springfield, Missouri, United States
CoxHealth South Hospital
Springfield, Missouri, United States
Mercy Infusion Center - Chippewa
St Louis, Missouri, United States
Missouri Baptist Medical Center
St Louis, Missouri, United States
Mercy Hospital Saint Louis
St Louis, Missouri, United States
Missouri Baptist Sullivan Hospital
Sullivan, Missouri, United States
BJC Outpatient Center at Sunset Hills
Sunset Hills, Missouri, United States
Mercy Hospital Washington
Washington, Missouri, United States
Community Hospital of Anaconda
Anaconda, Montana, United States
Billings Clinic Cancer Center
Billings, Montana, United States
Bozeman Health Deaconess Hospital
Bozeman, Montana, United States
Benefis Sletten Cancer Institute
Great Falls, Montana, United States
Great Falls Clinic
Great Falls, Montana, United States
Saint Peter's Community Hospital
Helena, Montana, United States
Logan Health Medical Center
Kalispell, Montana, United States
Saint Patrick Hospital - Community Hospital
Missoula, Montana, United States
Community Medical Center
Missoula, Montana, United States
Margaret R Pardee Memorial Hospital
Hendersonville, North Carolina, United States
ECU Health Oncology Kinston
Kinston, North Carolina, United States
FirstHealth of the Carolinas-Moore Regional Hospital
Pinehurst, North Carolina, United States
Sanford Bismarck Medical Center
Bismarck, North Dakota, United States
Sanford Broadway Medical Center
Fargo, North Dakota, United States
Sanford Roger Maris Cancer Center
Fargo, North Dakota, United States
Cleveland Clinic Mercy Hospital
Canton, Ohio, United States
Dayton Physicians LLC-Miami Valley South
Centerville, Ohio, United States
Miami Valley Hospital South
Centerville, Ohio, United States
Oncology Hematology Care Inc-Kenwood
Cincinnati, Ohio, United States
Good Samaritan Hospital - Dayton
Dayton, Ohio, United States
Miami Valley Hospital
Dayton, Ohio, United States
Dayton Physician LLC - Englewood
Dayton, Ohio, United States
Miami Valley Hospital North
Dayton, Ohio, United States
Armes Family Cancer Center
Findlay, Ohio, United States
Blanchard Valley Hospital
Findlay, Ohio, United States
Orion Cancer Care
Findlay, Ohio, United States
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, United States
Dayton Physicians LLC-Atrium
Franklin, Ohio, United States
Dayton Physicians LLC-Wayne
Greenville, Ohio, United States
Wayne Hospital
Greenville, Ohio, United States
Greater Dayton Cancer Center
Kettering, Ohio, United States
Kettering Medical Center
Kettering, Ohio, United States
Dayton Physicians LLC-Signal Point
Middletown, Ohio, United States
Dayton Physicians LLC-Wilson
Sidney, Ohio, United States
Springfield Regional Cancer Center
Springfield, Ohio, United States
Springfield Regional Medical Center
Springfield, Ohio, United States
Dayton Physicians LLC - Troy
Troy, Ohio, United States
Upper Valley Medical Center
Troy, Ohio, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Saint Charles Health System
Bend, Oregon, United States
Clackamas Radiation Oncology Center
Clackamas, Oregon, United States
Providence Cancer Institute Clackamas Clinic
Clackamas, Oregon, United States
Bay Area Hospital
Coos Bay, Oregon, United States
Providence Newberg Medical Center
Newberg, Oregon, United States
Providence Willamette Falls Medical Center
Oregon City, Oregon, United States
Providence Portland Medical Center
Portland, Oregon, United States
Providence Saint Vincent Medical Center
Portland, Oregon, United States
Penn State Health Saint Joseph Medical Center
Reading, Pennsylvania, United States
Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota, United States
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, United States
Baptist Memorial Hospital and Cancer Center-Collierville
Collierville, Tennessee, United States
Baptist Memorial Hospital and Cancer Center-Memphis
Memphis, Tennessee, United States
M D Anderson Cancer Center
Houston, Texas, United States
Audie L Murphy VA Hospital
San Antonio, Texas, United States
Cancer Therapy and Research Center at The UT Health Science Center at San Antonio
San Antonio, Texas, United States
University Hospital
San Antonio, Texas, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Providence Regional Cancer System-Aberdeen
Aberdeen, Washington, United States
PeaceHealth Saint Joseph Medical Center
Bellingham, Washington, United States
Providence Regional Cancer System-Centralia
Centralia, Washington, United States
Swedish Cancer Institute-Edmonds
Edmonds, Washington, United States
Providence Regional Cancer Partnership
Everett, Washington, United States
Swedish Cancer Institute-Issaquah
Issaquah, Washington, United States
Kadlec Clinic Hematology and Oncology
Kennewick, Washington, United States
Providence Regional Cancer System-Lacey
Lacey, Washington, United States
PeaceHealth Saint John Medical Center
Longview, Washington, United States
Pacific Gynecology Specialists
Seattle, Washington, United States
Swedish Medical Center-Ballard Campus
Seattle, Washington, United States
Kaiser Permanente Washington
Seattle, Washington, United States
Swedish Medical Center-Cherry Hill
Seattle, Washington, United States
Swedish Medical Center-First Hill
Seattle, Washington, United States
Providence Regional Cancer System-Shelton
Shelton, Washington, United States
MultiCare Deaconess Cancer and Blood Specialty Center - Downtown
Spokane, Washington, United States
MultiCare Deaconess Cancer and Blood Specialty Center - North
Spokane, Washington, United States
MultiCare Deaconess Cancer and Blood Specialty Center - Valley
Spokane Valley, Washington, United States
PeaceHealth Southwest Medical Center
Vancouver, Washington, United States
Providence Saint Mary Regional Cancer Center
Walla Walla, Washington, United States
Providence Regional Cancer System-Yelm
Yelm, Washington, United States
Billings Clinic-Cody
Cody, Wyoming, United States
Welch Cancer Center
Sheridan, Wyoming, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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NCI-2011-02592
Identifier Type: REGISTRY
Identifier Source: secondary_id
CHNMC-PHII-111
Identifier Type: -
Identifier Source: secondary_id
CDR0000701003
Identifier Type: -
Identifier Source: secondary_id
PHII-111
Identifier Type: -
Identifier Source: secondary_id
S1206
Identifier Type: -
Identifier Source: secondary_id
8811
Identifier Type: OTHER
Identifier Source: secondary_id
8811
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-2011-02592
Identifier Type: -
Identifier Source: org_study_id