Trial Outcomes & Findings for Docetaxel and Epirubicin in Advanced Gastric Cancer (NCT NCT00375999)
NCT ID: NCT00375999
Last Updated: 2014-03-03
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
34 participants
Primary outcome timeframe
One year
Results posted on
2014-03-03
Participant Flow
Participant milestones
| Measure |
Treatment Group
Salvage Chemotherapy with Docetaxel and Epirubicin for Advanced/Metastatic Gastric Cancer
|
|---|---|
|
Overall Study
STARTED
|
34
|
|
Overall Study
COMPLETED
|
32
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Docetaxel and Epirubicin in Advanced Gastric Cancer
Baseline characteristics by cohort
| Measure |
Treatment Group
n=34 Participants
Salvage Chemotherapy with Docetaxel and Epirubicin for Advanced/Metastatic Gastric Cancer
|
|---|---|
|
Age, Continuous
|
53 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
|
Region of Enrollment
Korea, Republic of
|
34 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: One yearOutcome measures
| Measure |
Treatment Group
n=32 Participants
Salvage Chemotherapy with Docetaxel and Epirubicin for Advanced/Metastatic Gastric Cancer
|
|---|---|
|
Overall Survival
|
13.4 month
Interval 7.0 to 19.8
|
Adverse Events
Treatment Group
Serious events: 3 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment Group
n=34 participants at risk
Salvage Chemotherapy with Docetaxel and Epirubicin for Advanced/Metastatic Gastric Cancer
|
|---|---|
|
Infections and infestations
sepsis
|
2.9%
1/34
|
|
Respiratory, thoracic and mediastinal disorders
pneumonia
|
5.9%
2/34
|
Other adverse events
| Measure |
Treatment Group
n=34 participants at risk
Salvage Chemotherapy with Docetaxel and Epirubicin for Advanced/Metastatic Gastric Cancer
|
|---|---|
|
Blood and lymphatic system disorders
neutropenia
|
47.1%
16/34 • Number of events 16
|
Additional Information
Dr. Jae Yong Cho
Gangnam Severance Hospital, Yonsei University College of Medicine
Phone: 82-2-2019-4363
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place