Gemcitabine With or Without Radiation Therapy in Treating Patients With Pancreatic Cancer

Pancreatic Cancer Clinical Trial

Official title:

A Randomized Phase III Study Of Gemcitabine In Combination With Radiation Therapy Versus Gemcitabine Alone In Patients With Localized, Unresectable Pancreatic Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00057876
• Other study ID #: CDR0000278947
• Secondary ID: U10CA021115E4201
• Status: Completed
• Phase: Phase 3
• Start date: August 29, 2003
• Est. completion date: May 2009

Study information

• Verified date: June 2023
• Source: Eastern Cooperative Oncology Group
• Contact: n/a
• Is FDA regulated: No
• 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. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether gemcitabine is more effective with or without radiation therapy in treating pancreatic cancer.

PURPOSE: Randomized phase III trial to study the effectiveness of gemcitabine with or without radiation therapy in treating patients who have locally advanced, unresectable pancreatic cancer.

Description:

OBJECTIVES:

• Compare the overall survival and progression-free of patients with locally advanced, unresectable pancreatic cancer treated with gemcitabine with or without radiotherapy.

• Compare the objective response rate in patients treated with these regimens.

• Compare the toxicity of these regimens in these patients.

• Compare the quality of life (QOL) of patients treated with these regimens.

• Determine the effect of gemcitabine and radiotherapy on the QOL of patients with improved objective response rate and progression-free and overall survival.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to performance status (0 vs. 1) and weight loss within the past 6 months (less than 10% vs. 10% or more). Patients are randomized to 1 of 2 treatment arms.

Arm I (Gemcitabine alone):

• Induction: Patients receive gemcitabine intravenously (IV) over 30-60 minutes once weekly for 6 weeks followed by 1 week of rest.

• Consolidation: After the 1 week of rest, patients receive gemcitabine IV once weekly for 3 weeks. Treatment repeats every 4 weeks for 5 courses in the absence of disease progression or unacceptable toxicity.

Arm II (Gemcitabine with radiotherapy):

• Induction: Patients receive gemcitabine IV over 30-60 minutes once weekly for 6 weeks beginning on day 1. Patients also undergo concurrent radiotherapy 5 days a week for 5.5 weeks beginning on day 1.

• Consolidation: Approximately 4 weeks after completion of radiotherapy, patients receive gemcitabine IV over 30-60 minutes once weekly for 3 weeks. Treatment repeats every 4 weeks for 5 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, week 6, week 15 (for arm II), week 16 (for arm I), and 9 months.

Patients are followed every 3 months for 2 years and then every 6 months for 1 year. Patients who receive treatment beyond 3 years are followed for survival.

ACCRUAL: 74 patients were accrued for this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologically or cytologically confirmed adenocarcinoma of the pancreas

• Locally advanced or regional (encompassable within the same radiotherapy portals)

• Adenosquamous cancers are allowed

• Unresectable disease

• Measurable and/or non-measurable disease as determined by computed tomography (CT) scan or magnetic resonance imaging (MRI), which must be performed within 4 weeks prior to randomization.

• Age>=18

• ECOG Performance status of 0-1

• Life expectancy >= 12 weeks

• Adequate bone marrow reserve,liver and renal function within 2 weeks of randomization:

• Absolute granulocyte count at least 2,000/mm^3

• Platelet count at least 100,000/mm^3

• Bilirubin less than 3 mg/dL (unless secondary to biliary obstruction or cholangitis)

• Serum glutamic-oxaloacetic (AST) less than 5 times upper limit of normal (ULN)

• Albumin greater than 2.5 g/dL

• Creatinine no greater than 1.5 times ULN

• Fertile patients must use effective contraception

• Willing and able to attend follow-up visits

• Concurrent enrollment on protocol ECOG-E1Y03 allowed

• More than 4 weeks since prior investigational agents

Exclusion Criteria:

• Candidate for surgical excision based on local extent of disease (e.g., T3, N1, M0)

• Stage M1 disease

• Small cell, mucinous cystadenocarcinoma, islet cell or papillary cystic histology

• Pregnant or nursing

• Active infection within within 4 weeks of randomization

• Malignancy within the past 5 years except nonmelanoma skin cancer, carcinoma in situ of the cervix, or organ-confined prostate cancer (Gleason score no greater than 7)

• History of active collagen vascular disease (i.e., systemic lupus erythematosus, rheumatoid arthritis, or scleroderma)

• Signs or symptoms of peptic or duodenal ulcer disease

• Concurrent serious systemic disorders that are incompatible with study participation

• Prior chemotherapy for pancreatic cancer

• Prior radiotherapy

• Concurrent intensity modulated radiotherapy

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• Gemcitabine
Induction: Patients receive the first cycle of gemcitabine 1000 mg/m^2 intravenously once per week for 6 weeks followed by 1 week rest. Consolidation: Following the week of rest, treatment resume with gemcitabine 1000 mg/m^2 administered intravenously once per week for 3 weeks, followed by 1 week rest, for 5 (4-week) cycles.

Radiation:
• radiation therapy
Induction: Patients receive gemcitabine 600 mg/m^2 intravenous infusion over 30-60 minutes once a week for 6 weeks while receiving radiation therapy. The first gemcitabine dose is given on the first day of radiation therapy (prior to radiation), then weekly thereafter. All patients on Arm B receive radiation therapy Monday through Friday (no radiation on Saturday or Sunday), weeks 1-6, with once/week gemcitabine. The radiation dose per fraction is 180 cGy prescribed to the isocenter. The total dose of radiation is 5040 cGy given in 28 fractions over 5 1/2 weeks. Consolidation: Additional cycles of gemcitabine begin approximately 4 weeks after completion of radiation therapy.

Locations

Country	Name	City	State
South Africa	Pretoria Academic Hospital	Pretoria, 0001
United States	Hickman Cancer Center at Bixby Medical Center	Adrian	Michigan
United States	McFarland Clinic, P.C.	Ames	Iowa
United States	Emory University Hospital - Atlanta	Atlanta	Georgia
United States	Rush-Copley Cancer Care Center	Aurora	Illinois
United States	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland
United States	Baton Rouge General Regional Cancer Center	Baton Rouge	Louisiana
United States	Mary Bird Perkins Cancer Center - Baton Rouge	Baton Rouge	Louisiana
United States	CCOP - Montana Cancer Consortium	Billings	Montana
United States	Bismarck Cancer Center	Bismarck	North Dakota
United States	Cancer Care Center at Medcenter One Hospital	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	Tufts - New England Medical Center	Boston	Massachusetts
United States	Bryn Mawr Hospital	Bryn Mawr	Pennsylvania
United States	Fairview Ridges Hospital	Burnsville	Minnesota
United States	Aultman Hospital Cancer Center at Aultman Health Foundation	Canton	Ohio
United States	Graham Hospital	Canton	Illinois
United States	University Hospitals Ireland Cancer Center at Mercy Medical Center	Canton	Ohio
United States	Memorial Hospital	Carthage	Illinois
United States	West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division	Charleston	West Virginia
United States	Martha Jefferson Hospital Cancer Care Center	Charlottesville	Virginia
United States	Hematology and Oncology Associates	Chicago	Illinois
United States	Mercy Hospital and Medical Center	Chicago	Illinois
United States	Robert H. Lurie Comprehensive Cancer Center at Northwestern University	Chicago	Illinois
United States	Swedish Covenant Hospital	Chicago	Illinois
United States	Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University	Cleveland	Ohio
United States	MetroHealth's Cancer Care Center at MetroHealth Medical Center	Cleveland	Ohio
United States	Ellis Fischel Cancer Center at University of Missouri - Columbia	Columbia	Missouri
United States	Mercy and Unity Cancer Center at Mercy Hospital	Coon Rapids	Minnesota
United States	Louis Busch Hager Cancer Center at Mary Imogene Bassett Hospital	Cooperstown	New York
United States	Genesis Regional Cancer Center at Genesis Medical Center	Davenport	Iowa
United States	Halifax Medical Center	Daytona Beach	Florida
United States	Veterans Affairs Medical Center - Atlanta (Decatur)	Decatur	Georgia
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	Delaware County Regional Cancer Center at Delaware County Memorial Hospital	Drexel Hill	Pennsylvania
United States	CCOP - Duluth	Duluth	Minnesota
United States	Miller-Dwan Medical Center	Duluth	Minnesota
United States	St. Mary's - Duluth Clinic Cancer Center	Duluth	Minnesota
United States	Veterans Affairs Medical Center - East Orange	East Orange	New Jersey
United States	Fairview Southdale Hospital	Edina	Minnesota
United States	St. Anthony's Memorial Hospital	Effingham	Illinois
United States	Elkhart General Hospital	Elkhart	Indiana
United States	Green Bay Oncology, Limited - Escanaba	Escanaba	Michigan
United States	Eureka Community Hospital	Eureka	Illinois
United States	Evanston Northwestern Health Care - Evanston Hospital	Evanston	Illinois
United States	Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center	Farmington	Connecticut
United States	Blanchard Valley Medical Associates	Findlay	Ohio
United States	Hunterdon Regional Cancer Center at Hunterdon Medical Center	Flemington	New Jersey
United States	Central Wisconsin Cancer Program at Agnesian HealthCare	Fond Du Lac	Wisconsin
United States	Fort Wayne Medical Oncology and Hematology	Fort Wayne	Indiana
United States	Fremont Memorial Hospital	Fremont	Ohio
United States	California Cancer Center - Woodward Park Office	Fresno	California
United States	Mercy and Unity Cancer Center at Unity Hospital	Fridley	Minnesota
United States	Northeast Georgia Medical Center	Gainesville	Georgia
United States	University of Florida Shands Cancer Center	Gainesville	Florida
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	Wayne Memorial Hospital, Incorporated	Goldsboro	North Carolina
United States	Great Falls Clinic	Great Falls	Montana
United States	North Colorado Medical Center	Greeley	Colorado
United States	Green Bay Oncology, Limited at St. Mary's Hospital	Green Bay	Wisconsin
United States	Green Bay Oncology, Limited at St. Vincent Hospital	Green Bay	Wisconsin
United States	St. Mary's Hospital Medical Center	Green Bay	Wisconsin
United States	St. Vincent Hospital Regional Cancer Center	Green Bay	Wisconsin
United States	Leo W. Jenkins Cancer Center at Pitt County Memorial Hospital	Greenville	North Carolina
United States	Mason District Hospital	Havana	Illinois
United States	Penn State Cancer Institute at Milton S. Hershey Medical Center	Hershey	Pennsylvania
United States	Hinsdale Hematology Oncology Associates	Hinsdale	Illinois
United States	Hopedale Medical Complex	Hopedale	Illinois
United States	Saint Joseph's Mercy Cancer Center	Hot Springs	Arkansas
United States	Marshall University Medical Center	Huntington	West Virginia
United States	Indiana University Cancer Center	Indianapolis	Indiana
United States	William N. Wishard Memorial Hospital	Indianapolis	Indiana
United States	Green Bay Oncology, Limited - Iron Mountain	Iron Mountain	Michigan
United States	Baptist Cancer Institute - Jacksonville	Jacksonville	Florida
United States	Mayo Clinic - Jacksonville	Jacksonville	Florida
United States	Joliet Oncology Hematology Associates, Limited - West	Joliet	Illinois
United States	Midwest Center for Hematology/Oncology	Joliet	Illinois
United States	Borgess Medical Center	Kalamazoo	Michigan
United States	Bronson Methodist Hospital	Kalamazoo	Michigan
United States	West Michigan Cancer Center	Kalamazoo	Michigan
United States	Provena St. Mary's Wasser Regional Cancer Center - Kankakee	Kankakee	Illinois
United States	Good Samaritan Health Systems	Kearney	Nebraska
United States	Kewanee Hospital	Kewanee	Illinois
United States	Baptist Regional Cancer Center at Baptist Hospital of East Tennessee	Knoxville	Tennessee
United States	Thompson Cancer Survival Center	Knoxville	Tennessee
United States	Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center	La Crosse	Wisconsin
United States	La Grange Memorial Hospital	La Grange	Illinois
United States	Center for Cancer Therapy at LaPorte Hospital and Health Services	La Porte	Indiana
United States	Deerpath Medical Associates	Lake Forest	Illinois
United States	Haematology-Oncology Associates of Ohio and Michigan, P.C.	Lambertville	Michigan
United States	Lancaster General Hospital	Lancaster	Pennsylvania
United States	Doctor's Hospital of Laredo	Laredo	Texas
United States	CCOP - Nevada Cancer Research Foundation	Las Vegas	Nevada
United States	Lewistown Hospital	Lewistown	Pennsylvania
United States	Central Baptist Hospital	Lexington	Kentucky
United States	North Shore Oncology and Hematology Associates, Limited - Libertyville	Libertyville	Illinois
United States	Lima Memorial Hospital	Lima	Ohio
United States	St. Rita's Medical Center	Lima	Ohio
United States	Bryan LGH Medical Center West	Lincoln	Nebraska
United States	Cancer Resource Center - Lincoln	Lincoln	Nebraska
United States	McKee Medical Center	Loveland	Colorado
United States	Joe Arrington Cancer Research and Treatment Center	Lubbock	Texas
United States	McDonough District Hospital	Macomb	Illinois
United States	Cancer Care Center at Holy Family Memorial Medical Center	Manitowoc	Wisconsin
United States	Bay Area Cancer Care Center at Bay Area Medical Center	Marinette	Wisconsin
United States	Fox Chase Virtua Health Cancer Program - Marlton	Marlton	New Jersey
United States	Marshfield Clinic - Marshfield Center	Marshfield	Wisconsin
United States	Mercy Cancer Center at Mercy Medical Center - North Iowa	Mason City	Iowa
United States	St. Luke's Hospital	Maumee	Ohio
United States	Saint Anthony Memorial Health Centers	Michigan City	Indiana
United States	Virginia Piper Cancer Institute at Abbott-Northwestern Hospital	Minneapolis	Minnesota
United States	Trinity Cancer Care Center	Minot	North Dakota
United States	Doctors Medical Center	Modesto	California
United States	Memorial Medical Center Cancer Services	Modesto	California
United States	Mercy Memorial Hospital System	Monroe	Michigan
United States	Cottonwood Hospital Medical Center	Murray	Utah
United States	New Britain General Hospital	New Britain	Connecticut
United States	Yale Comprehensive Cancer Center at Yale University School of Medicine	New Haven	Connecticut
United States	MBCCOP - LSU Health Sciences Center	New Orleans	Louisiana
United States	Medical Center of Louisiana - New Orleans	New Orleans	Louisiana
United States	Northwest Medical Specialist, PC	Niles	Illinois
United States	BroMenn Regional Medical Center	Normal	Illinois
United States	Community Cancer Center	Normal	Illinois
United States	William W. Backus Hospital	Norwich	Connecticut
United States	Green Bay Oncology, Limited - Oconto Falls	Oconto Falls	Wisconsin
United States	McKay-Dee Hospital Center	Ogden	Utah
United States	Bergan Mercy Medical Center	Omaha	Nebraska
United States	CCOP - Missouri Valley Cancer Consortium	Omaha	Nebraska
United States	Creighton University Medical Center	Omaha	Nebraska
United States	Immanuel Medical Center	Omaha	Nebraska
United States	Methodist Cancer Center at Methodist Hospital - Omaha	Omaha	Nebraska
United States	Burgess Health Center	Onawa	Iowa
United States	St. Charles Mercy Hospital	Oregon	Ohio
United States	Community Hospital of Ottawa	Ottawa	Illinois
United States	Ottumwa Regional Health Center Cancer Center	Ottumwa	Iowa
United States	Paoli Memorial Hospital	Paoli	Pennsylvania
United States	Midlands Cancer Center at Midlands Community Hospital	Papillion	Nebraska
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	Albert Einstein Cancer Center	Philadelphia	Pennsylvania
United States	Kimmel Cancer Center at Thomas Jefferson University - Philadelphia	Philadelphia	Pennsylvania
United States	Banner Good Samaritan Medical Center	Phoenix	Arizona
United States	Phoenixville Hospital	Phoenixville	Pennsylvania
United States	Hillman Cancer Center at University of Pittsburgh Cancer Institute	Pittsburgh	Pennsylvania
United States	Veterans Affairs Medical Center - Pittsburgh	Pittsburgh	Pennsylvania
United States	Perry Memorial Hospital	Princeton	Illinois
United States	Utah Valley Regional Medical Center - Provo	Provo	Utah
United States	St. Joseph Medical Center	Reading	Pennsylvania
United States	Booker Cancer Center at Riverview Medical Center	Red Bank	New Jersey
United States	Bon Secours Cancer Care at St. Mary's Hospital	Richmond	Virginia
United States	Hubert H. Humphrey Cancer Center at North Memorial Medical Center	Robbinsdale	Minnesota
United States	Mayo Clinic Cancer Center	Rochester	Minnesota
United States	Swedish American Hospital	Rockford	Illinois
United States	William Beaumont Hospital - Royal Oak Campus	Royal Oak	Michigan
United States	CentraCare Clinic - River Campus	Saint Cloud	Minnesota
United States	Dixie Regional Medical Center	Saint George	Utah
United States	Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph	Saint Joseph	Michigan
United States	CCOP - Metro-Minnesota	Saint Louis Park	Minnesota
United States	Park Nicollet Health Services	Saint Louis Park	Minnesota
United States	United Hospital	Saint Paul	Minnesota
United States	LDS Hospital	Salt Lake City	Utah
United States	Utah Cancer Specialists at UCS Cancer Center	Salt Lake City	Utah
United States	Firelands Regional Medical Center	Sandusky	Ohio
United States	Cancer Care and Research Pavilion at St. Joseph's/Candler	Savannah	Georgia
United States	Guthrie Medical Center - Sayre	Sayre	Pennsylvania
United States	Hematology and Oncology Associates	Scranton	Pennsylvania
United States	Swedish Cancer Institute at Swedish Medical Center - First Hill Campus	Seattle	Washington
United States	Mercy Medical Center - Sioux City	Sioux City	Iowa
United States	Siouxland Hematology-Oncology Associates at June E. Nylen 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, P. C.	Sioux Falls	South Dakota
United States	Sioux Valley Hospital and University of South Dakota Medical Center	Sioux Falls	South Dakota
United States	Hematology Oncology Associates - Skokie	Skokie	Illinois
United States	Hematology/Oncology of the North Shore at Gross Point Medical Center	Skokie	Illinois
United States	Midwest Cancer Research Group, Incorporated	Skokie	Illinois
United States	Shore Memorial Hospital - Somers Point	Somers Point	New Jersey
United States	CCOP - Northern Indiana CR Consortium	South Bend	Indiana
United States	Memorial Hospital of South Bend	South Bend	Indiana
United States	Saint Joseph Regional Medical Center	South Bend	Indiana
United States	St. Margaret's Hospital	Spring Valley	Illinois
United States	Valley Cancer Center	Spring Valley	Illinois
United States	Hulston Cancer Center at Cox Medical Center South	Springfield	Missouri
United States	St. John's Regional Health Center	Springfield	Missouri
United States	Mount Nittany Medical Center	State College	Pennsylvania
United States	Green Bay Oncology, Limited - Sturgeon Bay	Sturgeon Bay	Wisconsin
United States	Promedica Cancer Center at Flower Hospital	Sylvania	Ohio
United States	Mercy Hospital of Tiffin	Tiffin	Ohio
United States	CCOP - Toledo Community Hospital	Toledo	Ohio
United States	Medical College of Ohio Cancer Institute	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	Community Regional Cancer Center at Community Medical Center	Toms River	New Jersey
United States	Natalie Warren Bryant Cancer Center at St. Francis Hospital	Tulsa	Oklahoma
United States	East Texas Medical Center Cancer Institute	Tyler	Texas
United States	Carle Cancer Center at Carle Foundation Hospital	Urbana	Illinois
United States	CCOP - Carle Cancer Center	Urbana	Illinois
United States	Pearlman Comprehensive Cancer Center at South Georgia Medical Center	Valdosta	Georgia
United States	Ridgeview Medical Center	Waconia	Minnesota
United States	St. Joseph Health Care Center	Warren	Ohio
United States	University of Wisconsin Cancer Center at Aspirus Wausau Hospital	Wausau	Wisconsin
United States	Fulton County Health Center	Wauseon	Ohio
United States	Chester County Hospital	West Chester	Pennsylvania
United States	Medical Oncology and Hematology Associates - West Des Moines	West Des Moines	Iowa
United States	Jennersville Regional Hospital	West Grove	Pennsylvania
United States	Reading Hospital and Medical Center	West Reading	Pennsylvania
United States	Zimmer Cancer Center at New Hanover Regional Medical Center	Wilmington	North Carolina
United States	Wilson Medical Center	Wilson	North Carolina
United States	Forsyth Regional Cancer Center at Forsyth Medical Center	Winston-Salem	North Carolina
United States	CCOP - MainLine Health	Wynnewood	Pennsylvania
United States	Lankenau Cancer Center at Lankenau Hospital	Wynnewood	Pennsylvania
United States	St. Elizabeth Cancer Center at St. Elizabeth Health Center - Youngstown	Youngstown	Ohio

Sponsors (3)

Lead Sponsor	Collaborator
Eastern Cooperative Oncology Group	National Cancer Institute (NCI), Radiation Therapy Oncology Group

Countries where clinical trial is conducted

United States,  South Africa, 

References & Publications (1)

Loehrer PJ, Powell ME, Cardenes HR, et al.: A randomized phase III study of gemcitabine in combination with radiation therapy versus gemcitabine alone in patients with localized, unresectable pancreatic cancer: E4201. [Abstract] J Clin Oncol 26 (Suppl 15)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival Time	Overall survival was defined as the time from randomization (registration) to death from any cause. Patients alive at last follow-up were censored. Patients were followed every 3 months for 2 years and then every 6 months for year 3. Patients received treatment beyond 3 years were also followed for survival.	assessed every 3 months for 2 years, then every 6 months for year 3
Secondary	Progression-free Survival Time	Time from randomization (registration) to the earlier of disease progression or death. Patients alive and progression-free at last follow-up were censored. Progressive disease was defined as at least a 20% increase in the sum of the longest diameters of target lesions (taking as reference the baseline sum longest diameter), or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Patients were followed every 3 months for 2 years and then every 6 months for year 3. Patients who received treatment beyond 3 years were also followed for survival.	assessed every 3 months for 2 years, then every 6 months for year 3
Secondary	Overall Response	Response was assessed per Response Evaluation Criteria In Solid Tumors (RECIST) by CT. Overall response included complete response (CR) and partial response (PR). CR was defined as the disappearance of all target and non-target lesions. PR was defined as CR of target lesions and persistence of one or more non-target lesions or at least a 30% decrease in the sum of the longest diameters of target lesions and non-progressive disease in the non-target lesions. The 71 eligible, treated participants were included in the analysis.	assessed at week 8, and every 3 months for 2 years, then every 6 months for year 3