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

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

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 year

Outcome measures

Outcome 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

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

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

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place