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Brief Title: Clinical Trial in Patients With Metastatic Colorectal Cancer
Official Title: A Multi-Center, Open Label, Parallel Group, Randomised, Phase IIB Clinical Trial to Evaluate the Safety and Efficacy of CoFactor and 5-FU Versus Leucovorin and 5-FU in Subjects With Metastatic Colorectal Carcinoma
Study ID: NCT00235898
Brief Summary: The objective of this trial is to compare efficacy and safety of CoFactor and 5-fluorouracil (5-FU) versus leucovorin and 5-FU in treatment of metastatic colorectal cancer.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Global Hospital, Hyderabad, Andhra Pradesh, India
Department of Medical Oncology, Nizam's Institute of Medical Sciences, Hyderabad, Andhra Pradesh, India
Kasturba Medical College, Mangalore, Attavar, India
Department of Medical Oncology, Deenanath Mangeshkar Hospital and Research Centre, Pune, Erandawane, India
Department of Medical Oncology, Kidwai Memorial Institute of Oncology, Bangalore, Karnataka, India
Department of Oncology, Christian Medical College, Vellore, Tamil Nadu, India
Manipal Hospital, Bangalore, , India
SMS Medical College Hospital, Jaipur, , India
Department of Medical Oncology, Dayanad Medical College and Hospital, Ludhiana, , India
Department of Medical Oncology, Jaslok Hospital and Research Centre, Mumbai, , India
Colorectal Cancer Clinic, Centrum Cancer Clinic Onkologii-Instytut im M. Skladowskiej-Curie, Roentgena, Warszawa, Poland
Department and Clinic for Oncology and Radiotherapy, Gdansk, , Poland
Department for Oncology and Radiotherapy, Szpital Morski im. PCK, Gdynia Redlowo, , Poland
Oncological Chemotherapy Clinic, Regionalny Osrodek Onkologiczny, Lodz, , Poland
Oncological Chemotherapy Department Centrum Onkologii Ziemi, Lublin, , Poland
Clinical Oncology Department, Wojewodski Szpital Zespolony, Torun, , Poland
Gastroenterology and Hepatology Department, Fundeni Clinical Institute, Bucharest, , Romania
Professor of Dr. Alexandru Trestioreanu, Institute of Oncology II, Bucharest, , Romania
Department of Medical Oncology and Radiotherapy II, Cluj-Napoca, , Romania
Medical Oncology Department, County Hospital Sibiu, Sibiu, , Romania
Clinical Center of Serbia, Belgrade, , Serbia
Institute of Oncology and Radiology Serbia, Belgrade, , Serbia
CHC Bezanijska, Belgrade, , Serbia
CHC Kragujevac, Kragujevac, , Serbia
Clinic Centre Nis, Nis, , Serbia
Clinic for Internal Medicine, Institute for Oncology Sremska, Sremska Kamenica, , Serbia
General Hospital Djordje Joanovic, Zrenjanin, , Serbia
Haematology/Lung/GI Cancer Services, Harlow, Essex, United Kingdom
Oncology Research, North Middlesex University Hospital, Middlesex, London, United Kingdom
Beatson Oncology Centre, Glasgow, , United Kingdom
Name: James Cassidy, MD
Affiliation: Beatson Oncology Centre
Role: PRINCIPAL_INVESTIGATOR