Clinical Trial Details

EORTC-40084-22084-GITCG-ROG

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A phase II-R and a phase III trial evaluating both *Erlotinib (PH II-R) and chemoradiation (PH III) as adjuvant treatment for patients with resected head of pancreas adenocarcinoma *(PH II-R Erlotinib randomization completed, arm 2 closed to accrual effective 04/02/14)

Study documentation

Trial Status Closed to Patient Entry
Dates Date of activation: 14-May-2013
Date Step1 close: 09-Jun-2015
Data management at EORTC No
Design Phase 3
Randomized open label
Targeted Sample size EORTC Groups: 300 - All Groups: 950
Treatment Radiotherapy, Drug, Drug
Fluorouracil, Capecitabine, Erlotinib, Gemcitabine
Study Staff Jean-Luc Van Laethem (Study Coordinator) , Hopitaux Universitaires Bordet-Erasme - Hopital Universitaire Erasme, Brussels
Marie-Ange Lentz (Data Manager) marie-ange.lentz (at) eortc.org, EORTC Headquarters, Brussels
Murielle Mauer (Statistician) murielle.mauer (at) eortc.org, EORTC Headquarters, Brussels
Sara Meloen (Pharmacovigilance Manager) sara.meloen (at) eortc.org, EORTC Headquarters, Brussels
Maira Seini (Regulatory Affairs Manager) maira.seini (at) eortc.org, EORTC Headquarters, Brussels
Type of cancer Pancreatic
Participating groups EORTC Gastrointestinal Tract Cancer Group
EORTC Radiation Oncology Group
Radiation Therapy Oncology Group
Recruiting centers AZ Groeninge Kortrijk - Campus Kennedylaan (Kortrijk, Belgium)
AZ Turnhout - Campus Sint Elisabeth (Turnhout, Belgium)
Cliniques Universitaires Saint-Luc (Brussels, Belgium)
Hopitaux Universitaires Bordet-Erasme - Hopital Universitaire Erasme (Brussels, Belgium)
Centers to be activated Abington Memorial Hospital (Abington, United States of America)
Adams Cancer Center (Gettysburg, United States of America)
Anderson Area Cancer Center - AnMed Health Cancer Center (Anderson, United States of America)
Billings Clinic-Orthopedics & Sports Medicine (Billings, United States of America)
CHC - Clinique Saint-Joseph (Liege, Belgium)
Cancer Centers of the Carolinas - Greer Medical Oncology (Greer, United States of America)
Carle Cancer Center (Urbana, United States of America)
Centre Hospitalier Régional Verviers (East Belgium) (Verviers, Belgium)
Centro Di Riferimento Oncologico (Aviano, Italy)
Christiana Care Health System- Christiana Hospital (Newark, United States of America)
Christina Care Health System (Wilmington, United States of America)
Dana-Farber Cancer Institute & Harvard Medical School (Boston, United States of America)
Delaware County Memorial Hospital (Drexel Hill, United States of America)
East Carolina Univ. Jenkins Cancer Center (Greenville, United States of America)
Easton Hospital (Easton, United States of America)
Easton Hospital (Easton, United States of America)
Geisinger Medical Center (Danville P.A., United States of America)
Henry Ford Hospital (Detroit, United States of America)
Hopital De Jolimont (Haine St Paul, Belgium)
Hôpitaux universitaires de Genève - HUG - site de Cluse-Roseraie (Geneve, Switzerland)
ICO L’Hospitalet - Hospital Duran i Reynals (Institut Catala D'Oncologia) (Barcelona, Spain)
Intermountain Medical Center (Murray, United States of America)
Iowa Methodist Medical Center (Iowa, United States of America)
Kaiser Permanente San Leandro Medical Center (San Leandro, United States of America)
Kinston Medical Specialists, P.A. (Kinston, United States of America)
Klinikum Der Philipps-Universitaet Marburg (Marburg, Germany)
Lankenau Medical Center (Wynnewood, United States of America)
Laura and Isaac Perlmutter Cancer Center at, NYU Langone (New York, United States of America)
Legacy Meridian Park Hospital (Tualatin, United States of America)
London Regional Cancer Center (London, Canada)
Low Country Cancer Care Associates (Savannah, United States of America)
Memorial Sloan-Kettering Cancer Center - Memorial hospital (New York, United States of America)
Memorial Sloan-Kettering Cancer Center - Memorial hospital (New York, United States of America)
Metro Minnesota Community Oncology Research Consortium (Minnesota, United States of America)
Michiana Hematology Oncology PC-Mishawaka (Mishawaka, United States of America)
Nevada Cancer Research Foundation CCOP – Cancer & Blood Specialists of Nevada (Las Vegas, United States of America)
Northern Indiana cancer research Consortium (South Bend, United States of America)
Ottawa Civic Hospital (Ottawa - Ontario, Canada)
Parkview Hospital (Fort Wayne, United States of America)
Reading hospital-Tower Health (West Reading, United States of America)
Rex Hospital Inc (Raleigh, United States of America)
Saint Agnes Hospital (Baltimore, United States of America)
Saint Agnes Hospital (Baltimore, United States of America)
Spartanburg Regional Medical Center (Spartanburg, United States of America)
Sutter Cancer Centers Radiation Oncology Services Vacaville (Fairfield, United States of America)
Sylvester Cancer Center - University Of Miami (Miami, United States of America)
The Mark H. Zangmeister Cancer Center (Columbus, United States of America)
The Miriam Hospital (Providence, United States of America)
The Valley Hospital (Ridgewood, United States of America)
Thomas Jefferson University Hospital-Jefferson Heart Institute (Philadelphia, United States of America)
Toledo Community Hospital Oncology (Toledo, United States of America)
Tyler Cancer Center (Tyler, United States of America)
U.Z. Leuven - Campus Gasthuisberg (Leuven, Belgium)
USC Norris Comprehensive Cancer Center (Los Angeles, United States of America)
Universitaetsklinikum Leipzig UCCL-Krebszentrum (Leipzig, Germany)
Universitair Ziekenhuis Antwerpen (Edegem, Belgium)
University Hospital Newark (Newark, United States of America)
University Of Chicago Comprehensive Cancer Center (Chicago, United States of America)
University Of Southern California-Comprehensive Cancer Center (Los Angeles, United States of America)
University of Kentuky (Lexington, United States of America)
University of Maryland Greenebaum Cancer Center (Baltimore - Maryland, United States of America)
University of Michigan (Ann Arbor, United States of America)
Utah Valley Regional Medical Center (Provo, United States of America)
Washington University School of Medicine - St. Louis (Saint Louis, United States of America)
Protocol summary http://clinicaltrials.gov/ct/show/
NCT number
EudraCT 2011-000618-20