Spots Global Cancer Trial Database for Efficacy and Safety of Palonosetron Hydrochloride in the Prevention of Nausea and Vomiting
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Trial Identification
Brief Title: Efficacy and Safety of Palonosetron Hydrochloride in the Prevention of Nausea and Vomiting
Official Title: A Multi-center, Stratified Randomized, Controlled Study to Evaluate the Efficacy and Safety of Palonosetron Hydrochloride in the Prevention of Nausea and Vomiting Associated With Moderate and Highly Emetogenic Chemotherapy in China
Study ID: NCT01481831
Study Description
Brief Summary: This purpose of this study is to evaluate the efficacy and safety of single and repeated doses of palonosetron hydrochloride in preventing nausea and vomiting caused by moderate and highly emetogenic chemotherapy in patients.
Detailed Description: Group I (Highly Emetogenic Chemotherapy): Patients that accepted chemotherapy including Cisplatin≥50mg/m2, Carmustine\>250mg/m2, Cyclophosphamide\>1500mg/m2, Dacarbazine\>60mg/m2, Doxorubicin\>60mg/m2, Epirubicin\>90mg/m2, IFO≥10g/m2 or AC program. Group II (Moderately Emetogenic Chemotherapy): Patients that accepted chemotherapy including any dose of Carboplatin, Daunorubicin, Oaliplatin, Irinotecan, or Doxorubicin\<60mg/m2(not include liposomal doxorubicin), Epirubicin≤90mg/m2, Carmustine≤250mg/m2, Methotrexate≥250mg/m2, Cyclophosphamide≤1500mg/m2, Arabinoside\>200mg/m2, IFO\<10g/m2, Cisplatin≥50mg/m2. Total subjects: 1000, single dose of palonosetron group of 500 patients, repeated doses of palonosetron group of 500 patients. According to the study subjects receiving highly emetogenic chemotherapy or moderately emetogenic chemotherapy, subjects are stratified randomize.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Anhui Provincial Hospital, Hefei, Anhui, China
Chinese Academy of Medical Sciences Cancer Hospital, Beijing, Beijing, China
Chinese PLA 301 Hospital, Beijing, Beijing, China
Chinese PLA 307 Hospital, Beijing, Beijing, China
Chinese PLA Navy General Hospital, Beijing, Beijing, China
Fuzhou General Hospital of Nanjing Military Command, Fuzhou, Fujian, China
Guangxi Cancer Hospital, Nanning, Guangxi, China
The Second Xiangya Hospital of Central South University, Changsha, Hunan, China
The First People's Hospital of Changzhou, Changzhou, Jiangsu, China
Nanjing General Hospital of Nanjing Military Command, Nanjing, Jiangsu, China
The First Affiliated Hospital of Soochow University, Suzhou, Jiangsu, China
The Fourth People's Hospital of Wuxi, Wuxi, Jiangsu, China
Shandong Cancer Hospital, Jinan, Shandong, China
Shandong Provincial Hospital, Jinan, Shandong, China
The Affiliated Hospital of Medical College Qingdao University, Qingdao, Shandong, China
Shanghai Changzheng Hospital, Shanghai, Shanghai, China
Shanghai Xinhua Hospital, Shanghai, Shanghai, China
Tangdu Hospital of Fourth Military Medical University, Xian, Shanxi, China
Contact Details
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