Paclitaxel Liposome and Cisplatin as First-line Chemotherapy in Patients With Metastatic Esophageal Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01998347|
Recruitment Status : Withdrawn (slow enrollment)
First Posted : November 28, 2013
Last Update Posted : November 20, 2015
|Condition or disease||Intervention/treatment||Phase|
|Esophageal Cancer||Drug: Paclitaxel liposome Drug: Cisplatin Drug: 5-fluorouracil||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Paclitaxel Liposome and Cisplatin as First-line Chemotherapy in Patients With Metastatic Esophageal Cancer: an Open-label, Randomised Phase 3 Trial.|
|Study Start Date :||November 2013|
|Estimated Primary Completion Date :||December 2017|
Experimental: Paclitaxel liposome and Cisplatin
Drug: paclitaxel liposome 175mg/m2, IV (in the vein) on day 1 of each 21 day cycle. Number of Cycles:up to 6 cycles.
Drug: cisplatin 37.5 mg/m2, IV (in the vein) on day 1~2 of each 21 day cycle. Number of Cycles: up to 6 cycles.
Drug: Paclitaxel liposome
Active Comparator: Cisplatin plus 5-fluorouracil
37.5 mg/m2, IV (in the vein) on day 1-2 of each 21 day cycle. Number of Cycles: up to 6 cycles.
5-fluorouracil: 200mg/m2, CIV (continuous intravenous infusion) on day 1~5 of each 21 day cycle. Number of Cycles: up to 6 cycles.
- median overall survival [ Time Frame: one year ]
- median progression free survival [ Time Frame: 6 months ]
- time to progression [ Time Frame: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01998347
|Department of medical oncology,Cancer hospital of Shantou University Medical colledge|
|Shantou, Guangdong, China, 515031|