Combination Chemotherapy in Treating Patients With Bladder Cancer

Bladder Cancer Clinical Trial

Official title:

Phase III Study Comparing Sequential Chemotherapy (AG-ITP) To Cisplatin And Gemcitabine As Adjuvant Treatment After Cystectomy For Transitional Cell Carcinoma Of The Bladder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00014534
• Other study ID #: CALGB-90104
• Secondary ID: P30CA008748CALGB
• Status: Completed
• Phase: Phase 3
• First received: April 10, 2001
• Last updated: July 12, 2016
• Start date: March 2004
• Est. completion date: April 2009

Study information

• Verified date: July 2016
• Source: Alliance for Clinical Trials in Oncology
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Randomized phase III trial to compare different combination chemotherapy regimens in treating patients who have advanced bladder cancer.

Description:

OBJECTIVES:

Primary

• Compare the survival of patients with completely resected locally advanced transitional cell carcinoma of the bladder treated with adjuvant doxorubicin and gemcitabine followed by paclitaxel and cisplatin vs adjuvant cisplatin and gemcitabine.

Secondary

• Compare the toxicity profiles of these regimens in these patients.

OUTLINE: This is a randomized study. Patients are stratified according to primary tumor status (5), and number of dissected nodes (0-10 or unknown vs > 10). Patients are randomized to one of two treatment arms.

• Arm I: Patients receive adjuvant gemcitabine IV over 30 minutes on days 1, 8, and 15 and cisplatin IV over 30-60 minutes on day 1. Treatment repeats every 4 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity.

• Arm II: Patients receive adjuvant doxorubicin IV over 45 minutes followed by gemcitabine IV over 2 hours on day 1. Patients also receive filgrastim (G-CSF) subcutaneously (SC) daily on days 3-10. Treatment repeats every 14 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Beginning 14 days after the completion of doxorubicin and gemcitabine, patients receive paclitaxel IV over 3 hours and cisplatin IV over 20-30 minutes on day 1. Patients also receive G-CSF SC daily on days 3-10 or 4-11. Treatment repeats every 14 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 18 months, every 6 months for 18 months, and then annually thereafter.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: April 2009
• Est. primary completion date: July 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Histologically confirmed transitional cell carcinoma of the bladder

• Any T, N+, M0 OR

• T3a-4a, N0, M0

• At least 6 weeks but no more than 3 months since prior complete resection of bladder

• Cystoprostatectomy plus pelvic lymph node dissection in males

• Cystectomy/total abdominal hysterectomy/bilateral salpingo-oophorectomy plus pelvic lymph node dissection in females

• Negative surgical margins

• Carcinoma in situ allowed

• No partial cystectomy or transurethral bladder tumor resection as definitive loco-regional therapy

• Prostate cancer detected in resected specimen allowed if post-operative PSA is no more than 0.05 mg/dL

• No metastatic or recurrent disease by post-operative chest x-ray and CT scan of abdomen and pelvis

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• ECOG 0-1

Hematopoietic:

• Absolute neutrophil count = 1,500/mm^3

• Platelet count = 150,000/mm^3

Hepatic:

• Bilirubin = 1.5 times upper limit of normal (ULN)

• Alkaline phosphatase = 2 times ULN

• AST = 2 times ULN

Renal:

• Creatinine = 1.5 mg/dL OR

• Creatinine clearance = 60 mL/min

Cardiovascular:

• Normal cardiac function by history, physical exam, or chest radiograph

• Left ventricular ejection fraction at least 50% by radionuclide ventriculogram or echocardiogram, for prior cardiac disease

• No New York Heart Association class III or IV heart disease

• No serious cardiac arrhythmias including first-, second-, and third-degree heart block

Other:

• Negative pregnancy test

• No uncontrolled infection

• No other active cancer within the past 5 years except non-melanoma skin cancer or curatively treated carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• No prior systemic chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• No prior radiotherapy to bladder

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bladder Cancer
• Carcinoma, Transitional Cell
• Urinary Bladder Neoplasms

Intervention

Biological:
• filgrastim
6 mg sub Q

Drug:
• cisplatin
60 mg/sq m IV
• doxorubicin hydrochloride
50 mg/ sq m IV
• gemcitabine hydrochloride
1000 mg/ sq m IV for Gem + cis arm and 2000 mg/sq m IV for gem + dox + peg arm

Locations

Country	Name	City	State
United States	Akron City Hospital at Summa Health System	Akron	Ohio
United States	Phoebe Cancer Center at Phoebe Putney Memorial Hospital	Albany	Georgia
United States	Emory University Hospital - Atlanta	Altanta	Georgia
United States	McFarland Clinic, P.C.	Ames	Iowa
United States	Rose Ramer Cancer Clinic at Anderson Area Medical Center	Anderson	South Carolina
United States	CCOP - Michigan Cancer Research Consortium	Ann Arbor	Michigan
United States	Fox Valley Hematology and Oncology	Appleton	Wisconsin
United States	Arroyo Grande Community Hospital	Arroyo Grande	California
United States	Randolph Hospital	Asheboro	North Carolina
United States	Hematology and Oncology of Northeast Georgia	Athens	Georgia
United States	MBCCOP-Medical College of Georgia Cancer Center	Augusta	Georgia
United States	Aurora Presbyterian Hospital	Aurora	Colorado
United States	Rush-Copley Cancer Care Center	Aurora	Illinois
United States	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland
United States	St. Francis Hospital and Health Centers	Beech Grove	Indiana
United States	CCOP - Montana Cancer Consortium	Billings	Montana
United States	Deaconess Billings Clinic - Downtown	Billings	Montana
United States	Deaconess Billings Clinic Cancer Center	Billings	Montana
United States	Northern Rockies Radiation Oncology Center	Billings	Montana
United States	St. Vincent Healthcare	Billings	Montana
United States	Bismarck Cancer Center	Bismarck	North Dakota
United States	Medcenter One Health System	Bismarck	North Dakota
United States	Mid Dakota Clinic, P.C.	Bismarck	North Dakota
United States	St. Alexius Medical Center	Bismarck	North Dakota
United States	St. Joseph Medical Center	Bloomington	Illinois
United States	St. Elizabeth Boardman Cancer Center	Boardman	Ohio
United States	Lynn Regional Cancer Center of Boca Raton Community Hospital	Boca Raton	Florida
United States	Boulder Community Hospital	Boulder	Colorado
United States	Bozeman Deaconess Hospital	Bozeman	Montana
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	Fairview Ridges Hospital	Burnsville	Minnesota
United States	St. James Community Hospital	Butte	Montana
United States	Cancer Institute of New Jersey at the Cooper University Hospital	Camden	New Jersey
United States	Graham Hospital	Canton	Illinois
United States	Memorial Hospital	Carthage	Illinois
United States	Cedar Rapids Oncology Associates	Cedar Rapids	Iowa
United States	Mercy Cancer Center at Mercy Medical Center	Cedar Rapids	Iowa
United States	St. Luke's Hospital	Cedar Rapids	Iowa
United States	Cancer Center of Kansas - Chanute	Chanute	Kansas
United States	Roper St. Francis Healthcare - Roper Hospital	Charleston	South Carolina
United States	West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division	Charleston	West Virginia
United States	Louis A. Weiss Memorial Hospital	Chicago	Illinois
United States	University of Chicago Cancer Research Center	Chicago	Illinois
United States	Adena Regional Medical Center	Chillicothe	Ohio
United States	Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio
United States	Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University	Cleveland	Ohio
United States	Penrose Cancer Center at Penrose Hospital	Colorado Springs	Colorado
United States	Missouri Cancer Associates	Columbia	Missouri
United States	Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University	Columbus	Ohio
United States	CCOP - Columbus	Columbus	Ohio
United States	Doctors Hospital at Ohio Health	Columbus	Ohio
United States	Grant Riverside Cancer Services	Columbus	Ohio
United States	John B. Amos Community Cancer Center	Columbus	Georgia
United States	Mount Carmel West Hospital	Columbus	Ohio
United States	Riverside Methodist Hospital Cancer Care	Columbus	Ohio
United States	Batte Cancer Center at Northeast Medical Center	Concord	North Carolina
United States	Mercy Hospital	Coon Rapids	Minnesota
United States	Danville Regional Medical Center	Danville	Virginia
United States	Geisinger Medical Center	Danville	Pennsylvania
United States	Genesis Medical Center - West Campus	Davenport	Iowa
United States	Genesis Regional Cancer Center at Genesis Medical Center	Davenport	Iowa
United States	CCOP - Dayton	Dayton	Ohio
United States	Good Samaritan Hospital	Dayton	Ohio
United States	Grandview Hospital	Dayton	Ohio
United States	Miami Valley Hospital	Dayton	Ohio
United States	Samaritan North Cancer Care Center	Dayton	Ohio
United States	Veterans Affairs Medical Center - Dayton	Dayton	Ohio
United States	Grady Memorial Hospital	Delaware	Ohio
United States	CCOP - Colorado Cancer Research Program, Incorporated	Denver	Colorado
United States	Porter Adventist Hospital	Denver	Colorado
United States	Presbyterian - St. Luke's Medical Center	Denver	Colorado
United States	Rose Medical Center	Denver	Colorado
United States	St. Joseph Hospital	Denver	Colorado
United States	CCOP - Iowa Oncology Research Association	Des Moines	Iowa
United States	John Stoddard Cancer Center at Iowa Lutheran Hospital	Des Moines	Iowa
United States	John Stoddard Cancer Center at Iowa Methodist Medical Center	Des Moines	Iowa
United States	Medical Oncology and Hematology Associates at John Stoddard Cancer Center	Des Moines	Iowa
United States	Medical Oncology and Hematology Associates at Mercy Cancer Center	Des Moines	Iowa
United States	Mercy Cancer Center at Mercy Medical Center - Des Moines	Des Moines	Iowa
United States	Mercy Capitol Hospital	Des Moines	Iowa
United States	Cancer Center of Kansas - Dodge City	Dodge City	Kansas
United States	Wendt Regional Cancer Center at Finley Hospital	Dubuque	Iowa
United States	Duke Comprehensive Cancer Center	Durham	North Carolina
United States	Veterans Affairs Medical Center - East Orange	East Orange	New Jersey
United States	John Smith, Jr./Dalton McMichael Cancer Center at Morehead Memorial Hospital	Eden	North Carolina
United States	Fairview Southdale Hospital	Edina	Minnesota
United States	Cancer Center of Kansas, P.A. - El Dorado	El Dorado	Kansas
United States	Elkhart General Hospital	Elkhart	Indiana
United States	Union Hospital Cancer Center at Union Hospital	Elkton MD	Maryland
United States	Swedish Medical Center	Englewood	Colorado
United States	Eureka Hospital	Eureka	Illinois
United States	Front Range Cancer Specialists	Fort Collins	Colorado
United States	Poudre Valley Hospital	Fort Collins	Colorado
United States	Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital	Fort Lauderdale	Florida
United States	Mercy and Unity Cancer Center at Mercy and Unity Hospitals	Fridley	Minnesota
United States	Galesburg Clinic	Galesburg	Illinois
United States	Galesburg Cottage Hospital	Galesburg	Illinois
United States	InterCommunity Cancer Center of Western Illinois	Galesburg	Illinois
United States	Charles R. Wood Cancer Center at Glens Falls Hospital	Glens Falls	New York
United States	Legacy Mount Hood Medical Center	Glesham	Oregon
United States	Wayne Memorial Hospital, Incorporated	Goldsboro	North Carolina
United States	Great Falls Clinic	Great Falls	Montana
United States	Sletten Regional Cancer Institute	Great Falls	Montana
United States	Moses Cone Regional Cancer Center at Wesley Long Community Hospital	Greensboro	North Carolina
United States	Bon Secours St. Francis Health System	Greenville	South Carolina
United States	CCOP - Greenville	Greenville	South Carolina
United States	Greenville Hospital System Cancer Center	Greenville	South Carolina
United States	CCOP - Northern New Jersey	Hackensack	New Jersey
United States	Cancer Institute of New Jersey at Hamilton	Hamilton	New Jersey
United States	Mason District Hospital	Havana	Illinois
United States	St. Peter's Hospital	Helena	Montana
United States	Penn State Cancer Institute at Milton S. Hershey Medical Center	Hershey	Pennsylvania
United States	Memorial Cancer Institute at Memorial Regional Hospital	Hollywood	Florida
United States	Hopedale Medical Complex	Hopedale	Illinois
United States	St. Mary's Medical Center	Huntington	West Virginia
United States	Hutchinson Area Health Care	Hutchinson	Minnesota
United States	Community Oncology Group - Independence	Independence	Ohio
United States	Indiana University Cancer Center	Indianapolis	Indiana
United States	William N. Wishard Memorial Hospital	Indianapolis	Indiana
United States	Holden Comprehensive Cancer Center at University of Iowa	Iowa City	Iowa
United States	Mayo Clinic - Jacksonville	Jacksonville	Florida
United States	Joliet Oncology Hematology Associates, Limited - West	Joliet	Illinois
United States	Ella Milbank Foshay Cancer Center at Jupiter Medical Center	Jupiter	Florida
United States	Bronson Methodist Hospital	Kalamazoo	Michigan
United States	West Michigan Cancer Center	Kalamazoo	Michigan
United States	Borgess Medical Center	Kalamazooaa	Michigan
United States	Kalispell Regional Medical Center	Kalispell	Montana
United States	Provena St. Mary's Wasser Regional Cancer Center - Kankakee	Kankakee	Illinois
United States	CCOP - Kansas City	Kansas City	Missouri
United States	Charles F. Kettering Memorial Hospital	Kettering	Ohio
United States	Kewanee Hospital	Kewanee	Illinois
United States	Cancer Center of Kansas - Kingman	Kingman	Kansas
United States	Lenoir Memorial Cancer Center	Kinston	North Carolina
United States	Cancer Treatment Center at Merle West Medical Center	Klamath Falls	Oregon
United States	Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center	La Crosse	Wisconsin
United States	Center for Cancer Therapy at LaPorte Hospital and Health Services	La Porte	Indiana
United States	Watson Clinic	Lakeland	Florida
United States	Fairfield Medical Center	Lancaster	Ohio
United States	CCOP - Southern Nevada Cancer Research Foundation	Las Vegas	Nevada
United States	University Medical Center of Southern Nevada	Las Vegas	Nevada
United States	Central Pennsylvania Hematology and Medical Oncology Associates, PC	Lemoyne	Pennsylvania
United States	Beebe Medical Center	Lewes	Delaware
United States	Central Maine Medical Center	Lewiston	Maine
United States	Lewistown Hospital	Lewistown	Pennsylvania
United States	Southwest Medical Center	Liberal	Kansas
United States	Meeker County Memorial Hospital	Litchfield	Minnesota
United States	Arkansas Cancer Research Center at University of Arkansas for Medical Sciences	Little Rock	Arkansas
United States	Sky Ridge Medical Center	Lone Tree	Colorado
United States	Hope Cancer Care Center at Longmont United Hospital	Longmont	Colorado
United States	McDonough District Hospital	Macomb	Illinois
United States	University of Wisconsin Comprehensive Cancer Center	Madison	Wisconsin
United States	UW Health Oncology	Madison	Wisconsin
United States	St. John's Hospital	Maplewood	Minnesota
United States	Strecker Cancer Center at Marietta Memorial Hospital	Marietta	Ohio
United States	Fox Chase Virtua Health Cancer Program - Marlton	Marlton	New Jersey
United States	Marshfield Clinic - Marshfield Center	Marshfield	Wisconsin
United States	Cardinal Bernardin Cancer Center at Loyola University Medical Center	Maywood	Illinois
United States	Lawrence Memorial Hospital of Medford	Medford	Massachusetts
United States	Riddle Memorial Hospital	Media	Pennsylvania
United States	CCOP - Mount Sinai Medical Center	Miami Beach	Florida
United States	Saint Anthony Memorial Health Centers	Michigan City	Indiana
United States	Middletown Regional Hospital	Middletown	Ohio
United States	Eastern Montana Cancer Center	Miles City	Montana
United States	Medical College of Wisconsin Cancer Center	Milwaukee	Wisconsin
United States	Providence Milwaukie Hospital	Milwaukie	Oregon
United States	Hennepin County Medical Center - Minneapolis	Minneapolis	Minnesota
United States	Veterans Affairs Medical Center - Minneapolis	Minneapolis	Minnesota
United States	Virginia Piper Cancer Institute at Abbott-Northwestern Hospital	Minneapolis	Minnesota
United States	Community Medical Center	Missoula	Montana
United States	Montana Cancer Center at St. Patrick Hospital and Health Sciences Center	Missoula	Montana
United States	Mary Babb Randolph Cancer Center at West Virginia University Hospitals	Morgantown	West Virginia
United States	Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center	Nashville	Tennessee
United States	Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School	New Brunswick	New Jersey
United States	CCOP - Christiana Care Health Services	Newark	Delaware
United States	Licking Memorial Cancer Care Program at Licking Memorial Hospital	Newark	Ohio
United States	Cancer Center of Kansas - Newton	Newton	Kansas
United States	BroMenn Regional Medical Center	Normal	Illinois
United States	Community Cancer Center	Normal	Illinois
United States	Oklahoma University Medical Center	Oklahoma City	Oklahoma
United States	Community Hospital of Ottawa	Ottawa	Illinois
United States	Oncology Hematology Associates of Central Illinois - Ottawa	Ottawa	Illinois
United States	Cancer Center of Kansas, P.A. - Parsons	Parsons	Kansas
United States	Cancer Treatment Center at Pekin Hospital	Pekin	Illinois
United States	CCOP - Illinois Oncology Research Association	Peoria	Illinois
United States	Methodist Medical Center of Illinois	Peoria	Illinois
United States	Oncology/Hematology Associates of Central Illinois, P.C.	Peoria	Illinois
United States	OSF St. Francis Medical Center	Peoria	Illinois
United States	Proctor Hospital	Peoria	Illinois
United States	Illinois Valley Community Hospital	Peru	Illinois
United States	Abramson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Joan Karnell Cancer Center at Pennsylvania Hospital	Philadelphia	Pennsylvania
United States	Kimmel Cancer Center at Thomas Jefferson University - Philadelphia	Philadelphia	Pennsylvania
United States	Hillman Cancer Center at University of Pittsburgh Cancer Institute	Pittsburg	Pennsylvania
United States	Saint Joseph Regional Medical Center - Plymouth Campus	Plymouth	Indiana
United States	CCOP - Columbia River Oncology Program	Portland	Oregon
United States	Comprehensive Cancer Center at Legacy Good Samaritan Hospital & Medical Center	Portland	Oregon
United States	Institute of Oncology at Vilnius University	Portland	Oregon
United States	Providence Cancer Center at Providence Portland Medical Center	Portland	Oregon
United States	Providence St. Vincent Medical Center	Portland	Oregon
United States	Pottstown Memorial Regional Cancer Center	Pottstown	Pennsylvania
United States	Pratt Cancer Center of Kansas	Pratt	Kansas
United States	Perry Memorial Hospital	Princeton	Illinois
United States	Miriam Hospital at Lifespan	Providence	Rhode Island
United States	Rhode Island Hospital	Providence	Rhode Island
United States	St. Mary-Corwin Regional Medical Center	Pueblo	Colorado
United States	Annie Penn Cancer Center	Reidsville	North Carolina
United States	Hubert H. Humphrey Cancer Center at North Memorial Medical Center	Robbinsdale	Minnesota
United States	James P. Wilmot Cancer Center at University of Rochester Medical Center	Rochester	New York
United States	Lipson Cancer and Blood Center at Rochester General Hospital	Rochester	New York
United States	Mayo Clinic Cancer Center	Rochester	Minnesota
United States	William Beaumont Hospital - Royal Oak Campus	Royal Oak	Michigan
United States	Rutherford Hospital	Rutherfordton	North Carolina
United States	CCOP - Metro-Minnesota	Saint Louis Park	Minnesota
United States	Cancer Care Center at Regions Hospital	Saint Paul	Minnesota
United States	Cancer Center of Kansas - Salina	Salina	Kansas
United States	Kaiser Permanente Medical Office -Vandever Medical Office	San Diego	California
United States	Rebecca and John Moores UCSD Cancer Center	San Diego	California
United States	Veterans Affairs Medical Center - San Diego	San Diego	California
United States	UCSF Comprehensive Cancer Center	San Francisco	California
United States	Veterans Affairs Medical Center - San Francisco	San Francisco	California
United States	Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center	Savannah	Georgia
United States	Maine Center for Cancer Medicine and Blood Disorders - Scarborough	Scarborough	Maine
United States	CCOP - Mayo Clinic Scottsdale Oncology Program	Scottsdale	Arizona
United States	Saint Francis Cancer Center	Shakopee	Minnesota
United States	Welch Cancer Center	Sheridan	Wyoming
United States	Mercy Medical Center - Sioux City	Sioux City	Iowa
United States	Siouxland Hematology-Oncology Associates	Sioux City	Iowa
United States	Siouxland Regional Cancer Center	Sioux City	Iowa
United States	St. Luke's Regional Medical Center	Sioux City	Iowa
United States	Avera McKennan Hospital and University Health Center	Sioux Falls	South Dakota
United States	Medical X-Ray Center	Sioux Falls	South Dakota
United States	Sioux Valley Hospital and University of South Dakota Medical Center	Sioux Falls	South Dakota
United States	CCOP - Northern Indiana CR Consortium	South Bend	Indiana
United States	Memorial Hospital of South Bend	South Bend	Indiana
United States	CCOP - Upstate Carolina	Spartanburg	South Carolina
United States	Gibbs Regional Cancer Center at Spartanburg Regional Medical Center	Spartanburg	South Carolina
United States	Providence Cancer Center at Holy Family Hospital	Spokane	Washington
United States	Providence Cancer Center at Sacred Heart Medical Center	Spokane	Washington
United States	St. Margaret's Hospital	Spring Valley	Illinois
United States	Valley Cancer Center	Spring Valley	Illinois
United States	Community Hospital of Springfield and Clark County	Springfield	Ohio
United States	Hulston Cancer Center at Cox Medical Center South	Springfield	Missouri
United States	Mercy Medical Center Oncology Unit	Springfield	Ohio
United States	Regional Cancer Center at Memorial Medical Center	Springfield	Illinois
United States	St. John's Regional Health Center	Springfield	Missouri
United States	St. Joseph's Hospital	St Paul	Minnesota
United States	St. Anthony's Cancer Center	St. Louis	Missouri
United States	Park Nicollet Clinic	St. Louis Park	Minnesota
United States	United Hospital	St. Paul	Minnesota
United States	Geisinger Medical Group	State College	Pennsylvania
United States	Mount Nittany Medical Center	State College	Pennsylvania
United States	Long Island Cancer Center at Stony Brook University Hospital	Stony Brook	New York
United States	CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.	Syracuse	New York
United States	Community General Hospital of Greater Syracuse	Syracuse	New York
United States	Veterans Affairs Medical Center - Syracuse	Syracuse	New York
United States	North Suburban Medical Center	Thorton	Colorado
United States	UVMC Cancer Care Center at Upper Valley Medical Center	Troy	Ohio
United States	Legacy Meridian Park Hospital	Tualatin	Oregon
United States	Carle Cancer Center at Carle Foundation Hospital	Urbana	Illinois
United States	CCOP - Carle Cancer Center	Urbana	Illinois
United States	Cancer Center at Southwest Washington Medical Center	Vancouver	Washington
United States	Fox Chase Virtua Health Cancer Program at Virtua West Jersey	Voorhees	New Jersey
United States	Ridgeview Medical Center	Waconia	Minnesota
United States	St. Joseph Health Care Center	Warren	Ohio
United States	Lombardi Cancer Center at Georgetown University Medical Center	Washington	District of Columbia
United States	Walter Reed Army Medical Center	Washington	District of Columbia
United States	University of Wisconsin Cancer Center at Aspirus Wausau Hospital	Wausau	Wisconsin
United States	Cancer Center of Kansas - Wellington	Wellington	Kansas
United States	Medical Oncology and Hematology Associates - West Des Moines	West Des Moines	Iowa
United States	Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital	Westerville	Ohio
United States	Associates in Womens Health	Wichita	Kansas
United States	Cancer Center of Kansas, P.A.	Wichita	Kansas
United States	Cancer Center of Kansas, P.A. - Wichita	Wichita	Kansas
United States	CCOP - Wichita	Wichita	Kansas
United States	Via Christi Cancer Center at Via Christi Regional Medical Center	Wichita	Kansas
United States	Geisinger Wyoming Valley Medical Center	Wilkes-Barre	Pennsylvania
United States	St. Francis Hospital	Wilmington	Delaware
United States	Wilson Medical Center	Wilson	North Carolina
United States	Cancer Center of Kansas - Winfield	Winfield	Kansas
United States	Comprehensive Cancer Center at Wake Forest University	Winston-Salem	North Carolina
United States	Woodwinds Hospital	Woodbury	Minnesota
United States	Cleveland Clinic - Wooster	Wooster	Ohio
United States	Ruth G. McMillan Cancer Center at Greene Memorial Hospital	Xenia	Ohio
United States	St. Elizabeth Cancer Center at St. Elizabeth Health Center - Youngstown	Youngstown	Ohio
United States	Genesis - Good Samaritan Hospital	Zanesville	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Alliance for Clinical Trials in Oncology	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival		4 years	No