Spots Global Cancer Trial Database for Combination Therapy With NC-6004 and Gemcitabine Versus Gemcitabine Alone in Pancreatic Cancer
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Trial Identification
Brief Title: Combination Therapy With NC-6004 and Gemcitabine Versus Gemcitabine Alone in Pancreatic Cancer
Official Title: A Phase III, Open-label, Randomized Study of the Combination Therapy With NC-6004 and Gemcitabine Versus Gemcitabine Alone in Patients With Locally Advanced or Metastatic Pancreatic Cancer
Study ID: NCT02043288
Conditions
Study Description
Brief Summary: This clinical trial is designed to evaluate the impact of the addition of NC-6004 to gemcitabine in the treatment of patients with locally advanced or metastatic pancreatic cancer in Asian countries.
Detailed Description: Pancreatic cancer is one of the most deadly cancers because of the predominately late diagnosis. Gemcitabine (GEM) is the standard treatment for advanced and metastatic pancreatic cancer. According to preclinical data and few early phase studies, a combined use of gemcitabine and cisplatin (CDDP) showed synergistic efficacy against pancreatic cancer. NC-6004, a novel micellar cisplatin formulation, retains the activity but avoids the renal toxicity and neurotoxicity caused by the high peak Cmax concentrations of cisplatin. This trial is designed to evaluate the impact of the addition of NC-6004 to gemcitabine in the treatment of patients with locally advanced or metastatic pancreatic cancer. The main hypothesis of this study is that NC-6004 plus gemcitabine combination is superior to gemcitabine alone in terms of overall survival in locally advanced or metastatic pancreatic cancer patients
Keywords
Eligibility
Minimum Age: 20 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Prince of Wales Hospital, Hong Kong, , Hong Kong
Queen Mary Hospital, Hong Kong, , Hong Kong
Aichi Cancer Center, Aichi, , Japan
Chiba Cancer Center, Chiba, , Japan
National Hospital Organization Kyushu Cancer Center, Fukuoka, , Japan
Hokkaido University Hospital, Hokkaido, , Japan
National Hospital Organization Osaka National Hospital, Osaka, , Japan
Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka, , Japan
Saitama Cancer Center, Saitama, , Japan
National Hospital Organization Shikoku Cancer Center, Shikokuchūō, , Japan
Shizuoka Cancer Center, Shizuoka, , Japan
Center Hospital of the National Center for Global Health and Medicine, Tokyo, , Japan
Kyorin university Hospital, Tokyo, , Japan
National Cancer Center Hospital East, Tokyo, , Japan
National Cancer Center Hospital, Tokyo, , Japan
The Cancer Institute Hospital of JFCR, Tokyo, , Japan
The University of Tokyo Hospital, Tokyo, , Japan
Kanagawa Cancer Center, Yokohama, , Japan
Ajou University Hospital (AUH), Gyeonggi-do, , Korea, Republic of
Samsung Medical Center (SMC), Seoul, , Korea, Republic of
The Catholic University of Korea, Seoul St. Mary's Hospital (CUK SSMH), Seoul, , Korea, Republic of
Korea University Guro Hospital (KUGH), Seoul, , Korea, Republic of
Yonsei University Health System, Severance Hospital, Seoul, , Korea, Republic of
Hospital Sultan Ismail, Johor Bahru, , Malaysia
Hospital Kuala Lumpur, Kuala Lumpur, , Malaysia
Makati Medical Center, Makati, , Philippines
National Cancer Centre, Singapore, , Singapore
Chiayi Chang Gung Memorial Hospital, Chiayi City, , Taiwan
Kaohsiung Medical University Hospital, Kaohsiung, , Taiwan
Chang Gung Memorial Hospital, Kaohsiung Branch, Kaohsiung, , Taiwan
China Medical University Hospital, Taichung, , Taiwan
Taichung Veterans General Hospital, Taichung, , Taiwan
National Cheng Kung University Hospital, Tainan, , Taiwan
Chi Mei Hospital, Tainan, , Taiwan
Mackay Memorial Hospital, Taipei, , Taiwan
National Taiwan University Hospital, Taipei, , Taiwan
Taipei Medical University Hospital, Taipei, , Taiwan
Koo Foundation Sun Yat-Sen Cancer Center, Taipei, , Taiwan
Taipei Veterans General Hospital, Taipei, , Taiwan
Tri-Service General Hospital, Taipei, , Taiwan
Taipei Medical University-Shuang-Ho Hospital, Ministry of Health and Welfare, Taipei, , Taiwan
Chang Gung Memorial Hospital, Linkou Branch, Taipei, , Taiwan
Chi Mei Medical Center, Yongkang, , Taiwan
Contact Details
Name: Li-Tzong Chen, M.D., Ph. D.
Affiliation: National Institute of Cancer Research, National Health Research Institutes
Role: PRINCIPAL_INVESTIGATOR
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