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NCT00049348 Clinical Trial

Chemotherapy and Radiation Therapy in Treating Patients With Locally Advanced Pancreatic Cancer

Pancreatic Cancer Clinical Trial

Official title:
A Randomized Phase II Study Of Gemcitabine Plus Radiotherapy Vs. Gemcitabine, 5-Fluorouracil And Cisplatin Followed By Radiotherapy And 5-Fluoraracil For Patients With Locally Advanced, Potentially Resectable Pancreatic Adenocarcinoma

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00049348
Other study ID # CDR0000258056
Secondary ID E1200
Status Completed
Phase Phase 2
First received
Last updated
Start date October 13, 2003
Est. completion date May 2009

Study information
Verified date June 2023
Source Eastern Cooperative Oncology Group
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

RATIONALE: Drugs used in chemotherapy use 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. Combining chemotherapy with radiation therapy before surgery may shrink the tumor so that it can be removed during surgery. PURPOSE: Randomized phase II trial to compare the effectiveness of two different regimens combining chemotherapy with radiation therapy in treating patients who are undergoing surgery for locally advanced pancreatic cancer.

Description:

OBJECTIVES: - Compare the percentage of margin-free resections in patients with locally advanced, potentially resectable adenocarcinoma of the pancreas treated with gemcitabine and radiotherapy vs gemcitabine, fluorouracil, and cisplatin followed by radiotherapy and fluorouracil. - Compare the efficacy of these regimens, as measured by CT scan response, in these patients. - Compare the posttreatment fibrosis in resected specimens of patients treated with these regimens. - Compare the toxicity of these regimens in these patients. - Compare the duration of objective response in patients treated with these regimens. - Compare the disease-free and overall survival of patients treated with these regimens. - Compare the effect of these regimens and disease recurrence on CA 19-9 values in these patients. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to superior mesenteric vein (SMV)/portal vein (PV) occlusion (yes vs no), SMV/PV/superior mesenteric artery/hepatic artery abutment or narrowing (yes vs no), prior exploration (yes vs no), and whether deemed to require preoperative therapy due to other factors (yes vs no). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients undergo radiotherapy once daily 5 days a week for 6 weeks. Patients receive gemcitabine IV over 50 minutes once weekly for 6 weeks during radiotherapy. Patients undergo surgical resection 4-6 weeks after completion of chemoradiotherapy. Maintenance therapy (4-8 weeks after completion of surgery): Patients receive gemcitabine IV over 100 minutes once weekly for 2 weeks. Treatment repeats every 3 weeks for 5 courses in the absence of disease progression or unacceptable toxicity. - Arm II: Patients receive gemcitabine IV over 30 minutes on days 1, 5, 29, and 33; cisplatin IV over 60 minutes on days 1-5 and 29-33; and fluorouracil IV continuously on days 1-4 and 29-32. Patients also receive filgrastim (G-CSF) subcutaneously (SC) daily on days 6-15 and 34-43 and epoetin alfa SC weekly on weeks 1-9. After completion of chemotherapy, patients undergo radiotherapy once daily 5 days a week for 6 weeks. Patients receive fluorouracil IV continuously daily during radiotherapy. Patients undergo surgical resection 4-6 weeks after completion of chemoradiotherapy. Maintenance therapy (4-8 weeks after completion of surgery): Patients receive gemcitabine IV over 100 minutes once weekly for 2 weeks. Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years and then every 6 months for 2 years. PROJECTED ACCRUAL: A total of 80-160 patients (40-80 per treatment arm) will be accrued for this study.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date May 2009
Est. primary completion date October 2005
Accepts healthy volunteers No
Gender All
Age group 18 Years to 120 Years
Eligibility DISEASE CHARACTERISTICS: - Histologically confirmed adenocarcinoma of the pancreas - No adenosquamous cancers or adenocarcinoma associated with cystic mucinous neoplasms - Locally advanced disease that is potentially resectable, previously explored and considered unresectable, or deemed to require preoperative treatment for other reasons - Primary cancer in the head, body, or tail of pancreas - Measurable disease - No 360 degree encirclement of the superior mesenteric artery, hepatic artery, or celiac axis - No metastases by CT scan and laparoscopy (if prior surgery, only CT scan required) PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 Life expectancy - Not specified Hematopoietic - Absolute granulocyte count greater than 2,000/mm^3 - Platelet count greater than 100,000/mm^3 Hepatic - Bilirubin less than 2 mg/dL (unless secondary to bile duct blockage by tumor) - Biliary obstruction by tumor requires biliary stent at least 9 French or biliary bypass before therapy Renal - Creatinine less than 1.7 mg/dL OR - Creatinine clearance greater than 60 mL/min Other - No other malignancy within the past 3 years except nonmelanoma skin cancer - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - No prior chemotherapy for this disease Endocrine therapy - Not specified Radiotherapy - No prior radiotherapy to pancreas Surgery - Not specified

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• epoetin alfa

• filgrastim

Drug:
• cisplatin

• fluorouracil

• gemcitabine hydrochloride

Procedure:
• adjuvant therapy

• conventional surgery

• neoadjuvant therapy

Radiation:
• radiation therapy

Locations
Country Name City State
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 Baton Rouge General Regional Cancer Center Baton Rouge Louisiana
United States Mary Bird Perkins Cancer Center - Baton Rouge Baton Rouge Louisiana
United States MeritCare Clinic - Bemidji Bemidji Minnesota
United States St. Luke's Hospital Cancer Center Bethlehem Pennsylvania
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 Beth Israel Deaconess Medical Center Boston Massachusetts
United States Fairview Ridges Hospital Burnsville Minnesota
United States Graham Hospital Canton Illinois
United States Memorial Hospital Carthage Illinois
United States Cancer Center of Kansas - Chanute Chanute Kansas
United States West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division Charleston West Virginia
United States Erlanger Cancer Center Chattanooga Tennessee
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 Veterans Affairs Medical Center - Lakeside Chicago Chicago Illinois
United States Mercy Hospital Coon Rapids Minnesota
United States Veterans Affairs Medical Center - Atlanta (Decatur) Decatur Georgia
United States Cancer Center of Kansas - Dodge City Dodge City Kansas
United States Fairview Southdale Hospital Edina Minnesota
United States St. Anthony's Memorial Hospital Effingham Illinois
United States Cancer Center of Kansas, P.A. - El Dorado El Dorado Kansas
United States Elkhart General Hospital Elkhart Indiana
United States Eureka Hospital Eureka Illinois
United States Evanston Northwestern Health Care - Evanston Hospital Evanston Illinois
United States CCOP - MeritCare Hospital Fargo North Dakota
United States MeritCare Medical Group Fargo North Dakota
United States Mercy and Unity Cancer Center at Mercy and Unity Hospitals Fridley Minnesota
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 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 Green Bay Wisconsin
United States Franklin Medical Center Greenfield Massachusetts
United States CCOP - Northern New Jersey Hackensack New Jersey
United States Mason District Hospital Havana Illinois
United States Penn State Cancer Institute at Milton S. Hershey Medical Center Hershey Pennsylvania
United States Holyoke Medical Center, Incorporated Holyoke Massachusetts
United States Hopedale Medical Complex Hopedale Illinois
United States Hutchinson Area Health Care Hutchinson Minnesota
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 Kewanee Hospital Kewanee Illinois
United States Cancer Center of Kansas - Kingman Kingman Kansas
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 Deerpath Medical Associates Lake Forest Illinois
United States Lewistown Hospital Lewistown Pennsylvania
United States Southwest Medical Center Liberal Kansas
United States North Shore Oncology and Hematology Associates, Limited - Libertyville Libertyville Illinois
United States St. Rita's Medical Center Lima Ohio
United States Meeker County Memorial Hospital Litchfield Minnesota
United States McDonough District Hospital Macomb Illinois
United States Medical Center of Central Georgia Macon Georgia
United States St. John's Hospital Maplewood Minnesota
United States Bay Area Cancer Care Center at Bay Area Medical Center Marinette Wisconsin
United States Saint Anthony Memorial Health Centers Michigan City Indiana
United States Hennepin County Medical Center - Minneapolis Minneapolis Minnesota
United States Virginia Piper Cancer Institute at Abbott-Northwestern Hospital Minneapolis Minnesota
United States Yale Comprehensive Cancer Center New Haven Connecticut
United States Cancer Center at Medical Center of Louisiana - New Orleans New Orleans Louisiana
United States MBCCOP - LSU Health Sciences Center New Orleans Louisiana
United States Cancer Center of Kansas - Newton Newton Kansas
United States Northwest Medical Specialist P.C. Niles Illinois
United States BroMenn Regional Medical Center Normal Illinois
United States Community Cancer Center Normal Illinois
United States Cancer Center of Kansas - Ottawa Ottawa Kansas
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 Fox Chase Cancer Center Philadelphia Pennsylvania
United States Saint Joseph Regional Medical Center - Plymouth Campus Plymouth Indiana
United States Pratt Cancer Center of Kansas Pratt Kansas
United States Perry Memorial Hospital Princeton Illinois
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 CCOP - Metro-Minnesota Saint Louis Park Minnesota
United States Park Nicollet Clinic Saint Louis Park Minnesota
United States Cancer Care Center at Regions Hospital Saint Paul Minnesota
United States St. Joseph's Hospital Saint Paul Minnesota
United States United Hospital Saint Paul Minnesota
United States Cancer Center of Kansas - Salina Salina Kansas
United States CCOP - Mayo Clinic Scottsdale Oncology Program Scottsdale Arizona
United States Saint Francis Cancer Center Shakopee Minnesota
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 Hematology Oncology Associates - Skokie Skokie Illinois
United States Hematology/Oncology of the North Shore Skokie Illinois
United States Midwest Cancer Research Group, Incorporated Skokie Illinois
United States CCOP - Northern Indiana CR Consortium South Bend Indiana
United States Memorial Hospital of South Bend South Bend Indiana
United States St. Margaret's Hospital Spring Valley Illinois
United States Valley Cancer Center Spring Valley Illinois
United States Baystate Regional Cancer Program at D'Amour Center for Cancer Care Springfield Massachusetts
United States Mount Nittany Medical Center State College Pennsylvania
United States Carle Cancer Center at Carle Foundation Hospital Urbana Illinois
United States CCOP - Carle Cancer Center Urbana Illinois
United States Ridgeview Medical Center Waconia Minnesota
United States St. Joseph Health Care Center Warren Ohio
United States Cancer Center of Kansas - Wellington Wellington Kansas
United States Noble Hospital Westfield Massachusetts
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 Wesley Medical Center Wichita Kansas
United States Cancer Center of Kansas - Winfield Winfield Kansas
United States Woodwinds Hospital Woodbury Minnesota
United States St. Elizabeth Cancer Center at St. Elizabeth Health Center - Youngstown Youngstown Ohio

Sponsors (2)
Lead Sponsor Collaborator
Eastern Cooperative Oncology Group National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Landry JC, Catalano P, Hoffman J, et al.: ECOG 1200: a randomized phase II trial of gemcitabine plus radiotherapy vs gemcitabine, 5-fluorouracil and cisplatin followed by radiotherapy and 5-fluorouracil in patients with locally advanced, potentially resec

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of margin-free resections produced by each program
Secondary Efficacy as measured by CT scan response
Secondary Post-treatment fibrosis in the resected specimens
Secondary Toxicity
Secondary Duration of objective response
Secondary Disease-free survival
Secondary Overall survival
Secondary Effect of therapy and recurrence on CA19-9 values
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