Spots Global Cancer Trial Database for EndoTAG-1+GEM vs GEM in Patients With Locally Advanced/Metastatic Pancreatic Adenocarcinoma Failed on FOLFIRINOX
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Trial Identification
Brief Title: EndoTAG-1+GEM vs GEM in Patients With Locally Advanced/Metastatic Pancreatic Adenocarcinoma Failed on FOLFIRINOX
Official Title: A Randomized Controlled, Open Label, Adaptive Phase-3 Trial to Evaluate Safety and Efficacy of EndoTAG-1+GEM vs GEM Alone in Patients With Measurable Locally Advanced/Metastatic Adenocarcinoma of the Pancreas Failed on FOLFIRINOX Treatment
Study ID: NCT03126435
Study Description
Brief Summary: The aim of this adaptive Phase 3 trial is to show a statistically significant superiority of EndoTAG-1 in combination with gemcitabine compared to gemcitabine monotherapy in patients with locally advanced/metastatic pancreatic cancer after FOLFIRINOX failure.
Detailed Description: The objective of the study was to assess the safety and efficacy of a combination therapy of EndoTAG-1 plus gemcitabine vs. gemcitabine monotherapy in patients with locally advanced and/or metastatic adenocarcinoma of the pancreas eligible for second-line therapy after failing first line therapy with FOLFIRINOX
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Compassionate Cancer Care Medical Group, Inc, Corona, California, United States
Emory University Hospital, Atlanta, Georgia, United States
John B. Amos Cancer Center / IACT Health, Columbus, Georgia, United States
Orchard Healthcare Research (OHR) Inc., Skokie, Illinois, United States
Investigator Clinical Research Centers of Indiana, Indianapolis, Indiana, United States
Cotton O'Neil Cancer Center (Stormont-Vail Cancer Center), Topeka, Kansas, United States
Karmanos Cancer Institute, Detroit, Michigan, United States
Henry Ford Hospital, Detroit, Michigan, United States
North Mississippi Hematology & Oncology Associates, Ltd., Tupelo, Mississippi, United States
Southeast Nebraska Cancer Center (SNCC) - Central Clinic - Main Clinic, Lincoln, Nebraska, United States
Guthrie - Corning Hospital - Guthrie Cancer Center, Sayre, Pennsylvania, United States
Charleston Cancer Center, North Charleston, South Carolina, United States
The Center for Cancer and Blood Disorders, Fort Worth, Texas, United States
Scott & White Vasicek Cancer Treatment Center, Temple, Texas, United States
Renovatioclinical, The Woodlands, Texas, United States
University of Virginia Hospital, Charlottesville, Virginia, United States
CHU Angers, Angers, , France
CHRU - Besançon, Besançon, , France
Hopital Haut Leveque, Bordeaux, , France
CHRU Brest - Hôpital Morvan, Brest, , France
Centre Hospitalier de Cholet, Cholet, , France
Centre Georges François Leclerc, Dijon, , France
Centre Hospitalier Départemental, La Roche-sur-Yon, , France
Hôpital Privé Jean Mermoz, Lyon, , France
La Timone, Marseille, , France
Institut de Cancérologie de Lorraine, Nancy, , France
Centre Antoine-Lacassagne, Nice, , France
Hopital La Pitié Salpétrière, Paris, , France
CH Saint Jean, Perpignan, , France
Centre Eugène Marquis, Rennes, , France
Clinique Sainte Anne/Strasbourg Oncologie Leberale, Strasbourg, , France
Dél-pesti Centrumkórház - Országos Hematológia és Infektológia Intézet, Budapest, , Hungary
Magyar Honvédség Egészségügyi Központ, Budapest, , Hungary
Országos Onkológiai Intézet, Budapest, , Hungary
Bács-Kiskun Megyei Kórház Onkoradiológiai Központ, Kecskemét, , Hungary
Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktatókórház, Miskolc, , Hungary
Pécsi Tudomány Egyetem Onkoterápiás Intézet, Pécs, , Hungary
Oncology Department, Hillel Yafe MC, Hadera, , Israel
Rambam Health Center, Haifa, , Israel
Meir Medical Center, Kfar Sava, , Israel
Rabin MC, Petach Tikva, , Israel
Tel Aviv Sourasky Medical Center, Tel Aviv, , Israel
Chungnam National University Hospital, Daejeon, , Korea, Republic of
National Cancer Center, Goyang-si, , Korea, Republic of
Inha University Hospital, Incheon-si, , Korea, Republic of
Chonnam National University Hwasun Hospital, Jeongnam, , Korea, Republic of
CHA Bundang Medical Center, Seongnam, , Korea, Republic of
Korea University Guro Hospital, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Severance Hospital, Seoul, , Korea, Republic of
Ajou University Hospital, Suwon, , Korea, Republic of
Arkhangelsk Clinical Oncological Dispensary, Arkhangel'sk, , Russian Federation
Kursk State Clinical Oncology Dispensary, Kursk, , Russian Federation
Federal State Budgetary Scientific Institution "Russian Oncological Scientific Center named after N.N.Blokhin", Moscow, , Russian Federation
Private clinnic "Medicine 24/7", Moscow, , Russian Federation
Budget Institution of Healthcare of Omsk Region "Clinical Oncology Dispensary", Omsk, , Russian Federation
State Budget Healthcare Institution "Orenburg Region Clinical Oncological Dispensary", Orenburg, , Russian Federation
State Budgetary Healthcare Institution Leningrad Regional Oncology Center, Saint Petersburg, , Russian Federation
Changhua Christian Hospital, Changhua, , Taiwan
Chang Gung Medical Foundation - Kaohsiung Branch, Kaohsiung, , Taiwan
E-Da Hospital, Kaohsiung, , Taiwan
China Medical University Hospital, Taichung, , Taiwan
National Cheng Kung University Hospital, Tainan, , Taiwan
Mackay Memorial Hospital-Taipei Branch, Taipei, , Taiwan
National Taiwan University Hospital, Taipei, , Taiwan
Taipei Veterans General Hospital, Taipei, , Taiwan
Tri-Service General Hospital (TSGH), Taipei, , Taiwan
Chang Gung Medical Foundation - Linkou Branch, Taoyuan, , Taiwan
Contact Details
Name: Li-Tzong Chen, M.D., Ph.D.
Affiliation: National Cheng Kung University Hospital,Tainan, Taiwan, R.O.C
Role: PRINCIPAL_INVESTIGATOR
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