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Capecitabine and Cisplatin (XP)+Sorafenib in Advanced Gastric Cancer (AGC) (XP+Sorafenib)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yoon-Koo Kang, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT00565370
First received: November 28, 2007
Last updated: August 1, 2015
Last verified: August 2015
Results First Received: December 15, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Advanced Gastric Cancer
Intervention: Drug: Capecitabine, Cisplatin, Sorafenib

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
XP Plus Sorafenib Capecitabine and cisplatin plus sorafenib Level 1 sorafenib 400 mg/d, capecitabine 1,600 mg/m2/d, cisplatin 80 mg/m2 Level 2 sorafenib 800 mg/d, capecitabine 1,600 mg/m2/d, cisplatin 80 mg/m2 Level 3 sorafenib 800 mg/d, capecitabine 2,000 mg/m2/d, cisplatin 80 mg/m2 Level 1A sorafenib 800 mg/d, capecitabine 1,600 mg/m2/d, cisplatin 60 mg/m2

Participant Flow:   Overall Study
    XP Plus Sorafenib
STARTED   21 
COMPLETED   21 
NOT COMPLETED   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All enrolled patients were analyzed for analysis.

Reporting Groups
  Description
XP Plus Sorafenib Capecitabine and cisplatin plus sorafenib

Baseline Measures
   XP Plus Sorafenib 
Overall Participants Analyzed 
[Units: Participants]
 21 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   16 
>=65 years   5 
Age 
[Units: Years]
Mean (Standard Deviation)
 53.7  (11.8) 
Gender 
[Units: Participants]
 
Female   5 
Male   16 
Region of Enrollment 
[Units: Participants]
 
Korea, Republic of   21 


  Outcome Measures
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1.  Primary:   Number of Participants Who Experienced Dose Limiting Toxicities (DLTs)   [ Time Frame: 28weeks ]

2.  Primary:   Progression-free Survival   [ Time Frame: 1 year ]

3.  Secondary:   Response Rate   [ Time Frame: 6 months ]

4.  Secondary:   Overall Survival   [ Time Frame: 28 months ]

5.  Secondary:   Toxicity Profile (According to National Cancer Institute Common Terminology Criteria for Adverse Event Version 3.0)   [ Time Frame: 28weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Yoon-Koo Kang
Organization: Asan Medical Center
phone: +82-2-3010-3210
e-mail: ykkang@amc.seoul.kr



Responsible Party: Yoon-Koo Kang, Asan Medical Center
ClinicalTrials.gov Identifier: NCT00565370     History of Changes
Other Study ID Numbers: AMC-ONCGI-0701
Study First Received: November 28, 2007
Results First Received: December 15, 2013
Last Updated: August 1, 2015
Health Authority: Korea: Food and Drug Administration