S0809: Capecitabine, Gemcitabine, and RT in Patients w/Cholangiocarcinoma of the Gallbladder or Bile Duct

Gallbladder Cancer Clinical Trial

Official title:

A Phase II Trial of Adjuvant Capecitabine/Gemcitabine Chemotherapy Followed By Concurrent Capecitabine and Radiotherapy in Extrahepatic Cholangiocarcinoma (EHCC)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00789958
• Other study ID #: S0809
• Secondary ID: S0809U10CA032102
• Status: Completed
• Phase: Phase 2
• First received: November 12, 2008
• Last updated: March 12, 2018
• Start date: December 2008
• Est. completion date: December 2017

Study information

• Verified date: March 2018
• Source: Southwest Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Drugs used in chemotherapy, such as capecitabine and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Giving more than one drug (combination chemotherapy) together with radiation therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving capecitabine together with gemcitabine followed by capecitabine and radiation therapy works in treating patients with cholangiocarcinoma of the gallbladder or bile duct.

Description:

OBJECTIVES:

• To estimate the stratum-specific (R0 and R1) and overall 2-year survival probabilities of patients with extrahepatic cholangiocarcinoma treated with adjuvant chemotherapy comprising capecitabine and gemcitabine hydrochloride, followed by capecitabine and radiotherapy. (R0 stratum closed as of 12-15-11)

• To estimate the 2-year stratum-specific and overall disease-free survival and local disease-free survival of patients treated with this regimen.

• To assess the frequency and severity of toxicity in patients treated with this regimen.

OUTLINE: This is a multicenter study. Patients are stratified according to margin of resection (negative [R0] vs microscopically positive [R1]). (R0 stratum closed as of 12-15-11)

• Adjuvant chemotherapy: Patients receive oral capecitabine every 12 hours on days 1-14 and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.

• Chemoradiotherapy: Beginning in week 13, patients receive oral capecitabine every 12 hours on days 1-7. Patients also undergo concurrent three-dimensional or intensity-modulated radiotherapy on days 1-5. Treatment repeats weekly for 5-6 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study therapy patients are followed periodically for up to 5 years.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: December 2017
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

DISEASE CHARACTERISTICS:

• Histopathologically confirmed extrahepatic cholangiocarcinoma of the gallbladder or bile duct, meeting at least 1 of the following criteria:

• Pathological T2-4 disease

• Pathological N1 disease

• Positive margins (any T or N )

• Must have undergone potentially curative radical resection with negative (R0) or microscopically positive (R1) margins within the past 56 days and recovered (R0 stratum closed as of 12-15-11)

• No distant metastatic disease as indicated by a CT scan or MRI of the chest, abdomen, and pelvis within the past 42 days

• Positive resected regional lymph nodes allowed

• No ampullary cancer

PATIENT CHARACTERISTICS:

• Zubrod performance status 0-1

• ANC > 1,500/µL

• Platelet count > 100,000/µL

• Serum creatinine < 1.5 mg/dL

• Total bilirubin < 1.5 times upper limit of normal (ULN)

• SGOT or SGPT < 2.5 times ULN

• Not pregnant or nursing

• Fertile patients must use effective contraception

• Able to swallow enteral medications and no requirement for a feeding tube

• No intractable nausea or vomiting

• No gastrointestinal (GI) tract disease resulting in an inability to take oral medication, malabsorption syndrome, requirement for IV alimentation, prior surgical procedures affecting absorptions. or uncontrolled inflammatory GI disease (e.g., Crohn disease, ulcerative colitis)

• No uncontrolled intercurrent illness including but not limited to any of the following:

• Ongoing or active infection

• Symptomatic congestive heart failure

• Unstable angina pectoris

• Cardiac arrhythmia

• Myocardial infarction or cerebrovascular accident within the past 3 months

• Uncontrolled diarrhea

• Psychiatric illness or social situations that would limit compliance with study requirements

• No prior malignancy except for adequately treated basal cell (or squamous cell) skin cancer, in situ cervical cancer, or other cancer from which the patient has been disease-free for 5 years

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• No prior chemotherapy or radiotherapy for this disease

• No prior upper abdominal radiotherapy

Related Conditions & MeSH terms

• Bile Duct Neoplasms
• Cholangiocarcinoma
• Extrahepatic Bile Duct Cancer
• Gallbladder Cancer
• Gallbladder Neoplasms

Intervention

Drug:
• capecitabine
Adjuvant chemotherapy: 1500 mg/m^2/day, PO, Every 12 hrs on Days 1-14 of each cycle Chemoradiotherapy: 1330 mg/m^2/day, PO, Every 12 hrs, 7 days per week beginning the first day of RT and finishing the last day of RT
• gemcitabine hydrochloride
1000 mg/m^2, IV, Days 1 & 8 of each cycle

Radiation:
• 3-dimensional conformal radiation therapy
4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 900 cGy during week 1 in 180 cGy fractions.
• intensity-modulated radiation therapy
4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 5,250 cGy in 210 cGy/fraction for a total of 25 fractions.

Locations

Country	Name	City	State
United States	Hickman Cancer Center at Bixby Medical Center	Adrian	Michigan
United States	Summa Center for Cancer Care at Akron City Hospital	Akron	Ohio
United States	American Fork Hospital	American Fork	Utah
United States	Island Hospital Cancer Care Center at Island Hospital	Anacortes	Washington
United States	AnMed Cancer Center	Anderson	South Carolina
United States	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan
United States	Regional Medical Center	Anniston	Alabama
United States	CCOP - Atlanta Regional	Atlanta	Georgia
United States	Northside Hospital Cancer Center	Atlanta	Georgia
United States	Piedmont Hospital	Atlanta	Georgia
United States	Saint Joseph's Hospital of Atlanta	Atlanta	Georgia
United States	Aurora Presbyterian Hospital	Aurora	Colorado
United States	University of Colorado Cancer Center at UC Health Sciences Center	Aurora	Colorado
United States	WellStar Cobb Hospital	Austell	Georgia
United States	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland
United States	Barberton Citizens Hospital	Barberton	Ohio
United States	Memorial Sloan-Kettering Cancer Center - Basking Ridge	Basking Ridge	New Jersey
United States	St. Francis Hospital and Health Centers - Beech Grove Campus	Beech Grove	Indiana
United States	St. Joseph Cancer Center	Bellingham	Washington
United States	Alta Bates Summit Comprehensive Cancer Center	Berkeley	California
United States	Billings Clinic - Downtown	Billings	Montana
United States	CCOP - Montana Cancer Consortium	Billings	Montana
United States	Hematology-Oncology Centers of the Northern Rockies - Billings	Billings	Montana
United States	St. Vincent Healthcare Cancer Care Services	Billings	Montana
United States	Medcenter One Hospital Cancer Care Center	Bismarck	North Dakota
United States	Mid Dakota Clinic, PC	Bismarck	North Dakota
United States	St. Alexius Medical Center Cancer Center	Bismarck	North Dakota
United States	Boston University Cancer Research Center	Boston	Massachusetts
United States	Boulder Community Hospital	Boulder	Colorado
United States	Bozeman Deaconess Cancer Center	Bozeman	Montana
United States	Olympic Hematology and Oncology	Bremerton	Washington
United States	Highline Medical Center Cancer Center	Burien	Washington
United States	Peninsula Medical Center	Burlingame	California
United States	Lahey Clinic Medical Center - Burlington	Burlington	Massachusetts
United States	Fairview Ridges Hospital	Burnsville	Minnesota
United States	St. James Healthcare Cancer Care	Butte	Montana
United States	Rocky Mountain Oncology	Casper	Wyoming
United States	Sandra L. Maxwell Cancer Center	Cedar City	Utah
United States	Cancer Center of Kansas, PA - Chanute	Chanute	Kansas
United States	Hollings Cancer Center at Medical University of South Carolina	Charleston	South Carolina
United States	Blumenthal Cancer Center at Carolinas Medical Center	Charlotte	North Carolina
United States	Presbyterian Cancer Center at Presbyterian Hospital	Charlotte	North Carolina
United States	Hematology and Oncology Associates	Chicago	Illinois
United States	Robert H. Lurie Comprehensive Cancer Center at Northwestern University	Chicago	Illinois
United States	University of Chicago Cancer Research Center	Chicago	Illinois
United States	Charles M. Barrett Cancer Center at University Hospital	Cincinnati	Ohio
United States	Clackamas Radiation Oncology Center	Clackamas	Oregon
United States	Medical Oncology and Hematology Associates - West Des Moines	Clive	Iowa
United States	Penrose Cancer Center at Penrose Hospital	Colorado Springs	Colorado
United States	John B. Amos Cancer Center	Columbus	Georgia
United States	Memorial Sloan-Kettering Cancer Center	Commack	New York
United States	Mercy and Unity Cancer Center at Mercy Hospital	Coon Rapids	Minnesota
United States	Danville Regional Medical Center	Danville	Virginia
United States	CCOP - Dayton	Dayton	Ohio
United States	David L. Rike Cancer Center at Miami Valley Hospital	Dayton	Ohio
United States	Good Samaritan Hospital	Dayton	Ohio
United States	Grandview Hospital	Dayton	Ohio
United States	Samaritan North Cancer Care Center	Dayton	Ohio
United States	Charles B. Eberhart Cancer Center at DeKalb Medical Center	Decatur	Georgia
United States	Decatur Memorial Hospital Cancer Care Institute	Decatur	Illinois
United States	CCOP - Colorado Cancer Research Program	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. Anthony Central Hospital	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	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan
United States	Cancer Center of Kansas, PA - Dodge City	Dodge City	Kansas
United States	CCOP - Hematology-Oncology Associates of Central New York	East Syracuse	New York
United States	Fairview Southdale Hospital	Edina	Minnesota
United States	Shaw Regional Cancer Center	Edwards	Colorado
United States	Cancer Center of Kansas, PA - El Dorado	El Dorado	Kansas
United States	Union Hospital of Cecil County	Elkton	Maryland
United States	Community Cancer Center	Elyria	Ohio
United States	Hematology Oncology Center	Elyria	Ohio
United States	Swedish Medical Center	Englewood	Colorado
United States	Piedmont Fayette Hospital	Fayetteville	Georgia
United States	Blanchard Valley Medical Associates	Findlay	Ohio
United States	Cancer Center of Kansas - Fort Scott	Fort Scott	Kansas
United States	Middletown Regional Hospital	Franklin	Ohio
United States	Fredericksburg Oncology, Incorporated	Fredericksburg	Virginia
United States	Mercy and Unity Cancer Center at Unity Hospital	Fridley	Minnesota
United States	Wayne Memorial Hospital, Incorporated	Goldsboro	North Carolina
United States	St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center	Grand Junction	Colorado
United States	St. Rose Ambulatory and Surgery Center	Great Bend	Kansas
United States	Great Falls Clinic - Main Facility	Great Falls	Montana
United States	Sletten Cancer Institute at Benefis Healthcare	Great Falls	Montana
United States	North Colorado Medical Center	Greeley	Colorado
United States	Wayne Hospital	Greenville	Ohio
United States	Hays Medical Center	Hays	Kansas
United States	St. Peter's Hospital	Helena	Montana
United States	Kellogg Cancer Care Center	Highland Park	Illinois
United States	M. D. Anderson Cancer Center at University of Texas	Houston	Texas
United States	Hutchinson Area Health Care	Hutchinson	Minnesota
United States	Hutchinson Hospital Corporation	Hutchinson	Kansas
United States	Cancer Center of Kansas-Independence	Independence	Kansas
United States	Swedish Medical Center - Issaquah Campus	Issaquah	Washington
United States	University of Mississippi Cancer Clinic	Jackson	Mississippi
United States	Borgess Medical Center	Kalamazoo	Michigan
United States	Bronson Methodist Hospital	Kalamazoo	Michigan
United States	West Michigan Cancer Center	Kalamazoo	Michigan
United States	Glacier Oncology, PLLC	Kalispell	Montana
United States	Kalispell Medical Oncology at KRMC	Kalispell	Montana
United States	Kalispell Regional Medical Center	Kalispell	Montana
United States	Provena St. Mary's Regional Cancer Center - Kankakee	Kankakee	Illinois
United States	Kansas City Cancer Centers - North	Kansas City	Missouri
United States	Kansas City Cancer Centers - South	Kansas City	Missouri
United States	Kansas City Cancer Centers - West	Kansas City	Kansas
United States	Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center	Kansas City	Kansas
United States	Truman Medical Center - Hospital Hill	Kansas City	Missouri
United States	Columbia Basin Hematology	Kennewick	Washington
United States	Charles F. Kettering Memorial Hospital	Kettering	Ohio
United States	Cancer Center of Kansas, PA - Kingman	Kingman	Kansas
United States	Rebecca and John Moores UCSD Cancer Center	La Jolla	California
United States	Lawrence Memorial Hospital	Lawrence	Kansas
United States	Gwinnett Medical Center	Lawrenceville	Georgia
United States	Kansas City Cancer Centers - East	Lee's Summit	Missouri
United States	Tunnell Cancer Center at Beebe Medical Center	Lewes	Delaware
United States	Cancer Center of Kansas, PA - Liberal	Liberal	Kansas
United States	North Shore Oncology and Hematology Associates, Limited - Libertyville	Libertyville	Illinois
United States	Lima Memorial Hospital	Lima	Ohio
United States	Arkansas Cancer Research Center at University of Arkansas for Medical Sciences	Little Rock	Arkansas
United States	Littleton Adventist Hospital	Littleton	Colorado
United States	Logan Regional Hospital	Logan	Utah
United States	Sky Ridge Medical Center	Lone Tree	Colorado
United States	Hope Cancer Care Center at Longmont United Hospital	Longmont	Colorado
United States	Kaiser Permanente Medical Center - Los Angeles	Los Angeles	California
United States	USC/Norris Comprehensive Cancer Center and Hospital	Los Angeles	California
United States	McKee Medical Center	Loveland	Colorado
United States	Lynchburg Hematology-Oncology Clinic	Lynchburg	Virginia
United States	Medical Center of Central Georgia	Macon	Georgia
United States	HealthEast Cancer Care at St. John's Hospital	Maplewood	Minnesota
United States	Minnesota Oncology - Maplewood	Maplewood	Minnesota
United States	Kennestone Cancer Center at Wellstar Kennestone Hospital	Marietta	Georgia
United States	Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton	Marlton	New Jersey
United States	Northwest Ohio Oncology Center	Maumee	Ohio
United States	Cardinal Bernardin Cancer Center at Loyola University Medical Center	Maywood	Illinois
United States	Cancer Center of Kansas, PA - McPherson	McPherson	Kansas
United States	Tucker Center for Cancer Care at Orange Regional Medical Center	Middletown	New York
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	Virginia Piper Cancer Institute at Abbott - Northwestern Hospital	Minneapolis	Minnesota
United States	Montana Cancer Center at St. Patrick Hospital and Health Sciences Center	Missoula	Montana
United States	Montana Cancer Specialists at Montana Cancer Center	Missoula	Montana
United States	Mercy Memorial Hospital - Monroe	Monroe	Michigan
United States	Skagit Valley Hospital Cancer Care Center	Mount Vernon	Washington
United States	Jon and Karen Huntsman Cancer Center at Intermountain Medical Center	Murray	Utah
United States	Edward Hospital Cancer Center	Naperville	Illinois
United States	CCOP - Ochsner	New Orleans	Louisiana
United States	Ochsner Cancer Institute at Ochsner Clinic Foundation	New Orleans	Louisiana
United States	New Ulm Medical Center	New Ulm	Minnesota
United States	CCOP - Christiana Care Health Services	Newark	Delaware
United States	Providence Newberg Medical Center	Newberg	Oregon
United States	Cancer Center of Kansas, PA - Newton	Newton	Kansas
United States	Cancer Care and Hematology Specialists of Chicagoland - Niles	Niles	Illinois
United States	Sutter Health - Western Division Cancer Research Group	Novato	California
United States	Val and Ann Browning Cancer Center at McKay-Dee Hospital Center	Ogden	Utah
United States	Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center	Orange	California
United States	St. Charles Mercy Hospital	Oregon	Ohio
United States	Willamette Falls Hospital	Oregon City	Oregon
United States	Kansas City Cancer Centers - Southwest	Overland Park	Kansas
United States	Parker Adventist Hospital	Parker	Colorado
United States	Cancer Center of Kansas, PA - Parsons	Parsons	Kansas
United States	Fox Chase Cancer Center - Philadelphia	Philadelphia	Pennsylvania
United States	Mount Carmel Regional Cancer Center	Pittsburg	Kansas
United States	UPMC Cancer Centers	Pittsburgh	Pennsylvania
United States	CCOP - Columbia River Oncology Program	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	Harrison Poulsbo Hematology and Onocology	Poulsbo	Washington
United States	Cancer Center of Kansas, PA - Pratt	Pratt	Kansas
United States	Utah Valley Regional Medical Center - Provo	Provo	Utah
United States	St. Mary - Corwin Regional Medical Center	Pueblo	Colorado
United States	Reid Hospital & Health Care Services	Richmond	Indiana
United States	Southern Regional Medical Center	Riverdale	Georgia
United States	Humphrey Cancer Center at North Memorial Outpatient Center	Robbinsdale	Minnesota
United States	Mayo Clinic Cancer Center	Rochester	Minnesota
United States	Memorial Sloan-Kettering Cancer Center - Rockville Centre	Rockville Centre	New York
United States	Harbin Clinic Cancer Center - Medical Oncology	Rome	Georgia
United States	Rutherford Hospital	Rutherfordton	North Carolina
United States	Dixie Regional Medical Center - East Campus	Saint George	Utah
United States	CCOP - Metro-Minnesota	Saint Louis Park	Minnesota
United States	Park Nicollet Cancer Center	Saint Louis Park	Minnesota
United States	Regions Hospital Cancer Care Center	Saint Paul	Minnesota
United States	United Hospital	Saint Paul	Minnesota
United States	Cancer Center of Kansas, PA - Salina	Salina	Kansas
United States	Tammy Walker Cancer Center at Salina Regional Health Center	Salina	Kansas
United States	LDS Hospital	Salt Lake City	Utah
United States	Utah Cancer Specialists at UCS Cancer Center	Salt Lake City	Utah
United States	California Pacific Medical Center - California Campus	San Francisco	California
United States	North Coast Cancer Care, Incorporated	Sandusky	Ohio
United States	Sutter Pacific Medical Foundation	Santa Rosa	California
United States	Fred Hutchinson Cancer Research Center	Seattle	Washington
United States	Group Health Central Hospital	Seattle	Washington
United States	Harborview Medical Center	Seattle	Washington
United States	Polyclinic First Hill	Seattle	Washington
United States	Swedish Cancer Institute at Swedish Medical Center - First Hill Campus	Seattle	Washington
United States	University Cancer Center at University of Washington Medical Center	Seattle	Washington
United States	North Puget Oncology at United General Hospital	Sedro-Woolley	Washington
United States	St. Francis Cancer Center at St. Francis Medical Center	Shakopee	Minnesota
United States	Kansas City Cancer Center - Shawnee Mission	Shawnee Mission	Kansas
United States	Mercy Medical Center - Sioux City	Sioux City	Iowa
United States	Siouxland Hematology-Oncology Associates, LLP	Sioux City	Iowa
United States	St. Luke's Regional Medical Center	Sioux City	Iowa
United States	Hematology Oncology Associates - Skokie	Skokie	Illinois
United States	Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center	Sleepy Hollow	New York
United States	CCOP - Upstate Carolina	Spartanburg	South Carolina
United States	Gibbs Regional Cancer Center at Spartanburg Regional Medical Center	Spartanburg	South Carolina
United States	Cancer Care Northwest - Spokane South	Spokane	Washington
United States	Evergreen Hematology and Oncology, PS	Spokane	Washington
United States	Lakeview Hospital	Stillwater	Minnesota
United States	Flower Hospital Cancer Center	Sylvania	Ohio
United States	SUNY Upstate Medical University Hospital	Syracuse	New York
United States	Mercy Hospital of Tiffin	Tiffin	Ohio
United States	CCOP - Toledo Community Hospital	Toledo	Ohio
United States	Medical University of Ohio Cancer Center	Toledo	Ohio
United States	St. Anne Mercy Hospital	Toledo	Ohio
United States	St. Vincent Mercy Medical Center	Toledo	Ohio
United States	Toledo Clinic, Incorporated - Main Clinic	Toledo	Ohio
United States	Toledo Hospital	Toledo	Ohio
United States	St. Francis Comprehensive Cancer Center	Topeka	Kansas
United States	UVMC Cancer Care Center at Upper Valley Medical Center	Troy	Ohio
United States	Natalie Warren Bryant Cancer Center at St. Francis Hospital	Tulsa	Oklahoma
United States	Sutter Solano Medical Center	Vallejo	California
United States	Northwest Cancer Specialists at Vancouver Cancer Center	Vancouver	Washington
United States	Southwest Washington Medical Center Cancer Center	Vancouver	Washington
United States	Cancer Institute of New Jersey at Cooper - Voorhees	Voorhees	New Jersey
United States	Fox Chase Virtua Health Cancer Program at Virtua West Jersey	Voorhees	New Jersey
United States	Ridgeview Medical Center	Waconia	Minnesota
United States	Lombardi Comprehensive Cancer Center at Georgetown University Medical Center	Washington	District of Columbia
United States	Washington Cancer Institute at Washington Hospital Center	Washington	District of Columbia
United States	Fulton County Health Center	Wauseon	Ohio
United States	Cancer Center of Kansas, PA - Wellington	Wellington	Kansas
United States	Wenatchee Valley Medical Center	Wenatchee	Washington
United States	Exempla Lutheran Medical Center	Wheat Ridge	Colorado
United States	Associates in Womens Health, PA - North Review	Wichita	Kansas
United States	Cancer Center of Kansas, PA - Medical Arts Tower	Wichita	Kansas
United States	Cancer Center of Kansas, PA - 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	Willmar Cancer Center at Rice Memorial Hospital	Willmar	Minnesota
United States	Cancer Center of Kansas, PA - Winfield	Winfield	Kansas
United States	Minnesota Oncology - Woodbury	Woodbury	Minnesota
United States	Ruth G. McMillan Cancer Center at Greene Memorial Hospital	Xenia	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Southwest Oncology Group	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stratum-specific (R0 and R1) 2-year Overall Survival	Time to death is calculated from date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.	Up to 2 years from registration
Secondary	Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug	Only adverse events that are possibly, probably or definitely related to study drug are reported.	Up to 5 years
Secondary	2-year Overall Survival for All Patients	Time to death is calculated from date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.	Up to 2 years from registration
Secondary	2-year Stratum-specific Disease-free Survival	Disease-free survival is calculated from date of registration to date of first documentation of relapse or death due to any cause. Patients last known to be alive are censored at date of last contact.	Up to 2 years from registration
Secondary	2-year Disease-free Survival in All Patients	Disease-free survival is calculated from date of registration to date of first documentation of relapse or death due to any cause. Patients last known to be alive are censored at date of last contact.	Up to 2 years from registration
Secondary	2-year Stratum-specific Local Relapse Rate	Local relapse is any evidence of new disease within the primary tumor bed or the regional (retroperitoneal, celiac, and portal vein nodes) lymphatics (these areas are to be encompassed within the radiation fields).	Up to 2 years from registration
Secondary	2-year Overall Local Relapse Rate	Local relapse is any evidence of new disease within the primary tumor bed or the regional (retroperitoneal, celiac, and portal vein nodes) lymphatics (these areas are to be encompassed within the radiation fields).	Up to 2 years from registration