Spots Global Cancer Trial Database for A Phase III Study to Assess the Efficacy and Safety of GV1001-Gem/Cap vs Gem/Cap in Pancreatic Cancer Patients
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Trial Identification
Brief Title: A Phase III Study to Assess the Efficacy and Safety of GV1001-Gem/Cap vs Gem/Cap in Pancreatic Cancer Patients
Official Title: A Prospective, Randomized, Open-label, Multicenter, Parallel Design, Phase III Study to Assess the Efficacy and Safety of GV1001 Concurrent With Gemcitabine/Capecitabine Versus Gemcitabine/Capecitabine Alone in Treating Locally Advanced and Metastatic Pancreatic Cancer Patients
Study ID: NCT02854072
Conditions
Study Description
Brief Summary: To assess treatment of GV1001 concurrent with Gemcitabine/Capecitabine versus Gemcitabine/Capecitabine alone in locally advanced and metastatic pancreatic cancer patients.
Detailed Description: This study is designed as a phase III, prospective, randomized, open-label, multicenter clinical trial comparing GV1001 concurrent with Gemcitabine/Capecitabine versus Gemcitabine/Capecitabine alone in treating locally advanced and metastatic pancreatic cancer patients. Patients will be treated until disease progression and will be subject to follow-up until death. Patients will be randomized equally between the two arms: 1. Gemcitabine and Capecitabine 2. GV1001+ Gemcitabine and Capecitabine
Keywords
Eligibility
Minimum Age: 19 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Chungbuk National University Hospital, Cheongju-si, Chungcheongbuk-do, Korea, Republic of
Wonju Severance Christian Hospital, Wonju-si, Gangwon-do, Korea, Republic of
National Cancer Center, Goyang-si, Gyeonggi-do, Korea, Republic of
Jeju National University Hospital, Jeju-si, Jeju-do, Korea, Republic of
Chonbuk National University Hospital, Jeonju-si, Jeollabuk-do, Korea, Republic of
Pusan National University Hospital, Busan, , Korea, Republic of
Daegu Catholic University Medical Center, Daegu, , Korea, Republic of
Konyang University Hospital, Daejeon, , Korea, Republic of
Chonnam National University Hospital, Gwangju, , Korea, Republic of
Gachon University Gil Medical Center, Incheon, , Korea, Republic of
Gangnam Severance Hospital, Seoul, , Korea, Republic of
Hanyang University Seoul Hospital, Seoul, , Korea, Republic of
Korea University Anam Hospital, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Severance Hospital, Seoul, , Korea, Republic of
Contact Details
Name: Si Young Song, M.D.
Affiliation: Severance Hospital
Role: STUDY_CHAIR
Name: Yong-Tae Kim, M.D.
Affiliation: Seoul National University Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Ho Soon Choi, M.D.
Affiliation: Hanyang University Seoul Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Ho Gak Kim, M.D.
Affiliation: Daegu Catholic University Medical Center
Role: PRINCIPAL_INVESTIGATOR
Name: Hong Sik Lee, M.D.
Affiliation: Korea University Anam Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Young Woo Choi, M.D.
Affiliation: Konyang University Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Gwang Ha Kim, M.D.
Affiliation: Pusan National University Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Kwang Hyuck Lee, M.D.
Affiliation: Samsung Medical Center
Role: PRINCIPAL_INVESTIGATOR
Name: Jae Hee Cho, M.D.
Affiliation: Gachon University Gil Medical Center
Role: PRINCIPAL_INVESTIGATOR
Name: Joung-Ho Han, M.D.
Affiliation: Chungbuk National University Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Seung Ok Lee, M.D.
Affiliation: Chonbuk National University Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Chang-Hwan Park, M.D.
Affiliation: Chonnam National University Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Eun Kwang Choi, M.D.
Affiliation: Jeju National University Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Kyong Joo Lee, M.D.
Affiliation: Wonju Severance Christian Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Jae Yong Cho, M.D.
Affiliation: Gangnam Severance Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Woo Jin Lee, M.D.
Affiliation: National Cancer Center
Role: PRINCIPAL_INVESTIGATOR
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