Status:
COMPLETED
Phase III Trial of DP Followed by FOLFIRI or the Reverse Sequence in Unresectable Gastric Cancer
Lead Sponsor:
Samsung Medical Center
Conditions:
Gastric Cancer
Metastases
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
To assess the optimal sequence of the palliative chemotherapy regimen (DP --\> FOLFIRI vs FOLFIRI --\> DP) in metastatic gastric cancer patients.
Detailed Description
Gastric cancer is the second leading cause of cancer death worldwide and is the most common malignancy in Korea. Metastatic gastric cancer remains a therapeutic challenge for medical oncologists due t...
Eligibility Criteria
Inclusion
- Histologically confirmed metastatic adenocarcinoma of the stomach
- Age ≥ 18
- Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
- Life expectancy of at least 3 months
- Adequate renal, liver, bone marrow functions
- Adjuvant chemotherapy more than 12 months from the date of study entry
- Written informed consent
Exclusion
- Active infection requiring antibiotics
- Pregnant, lactating women
- Brain metastasis
- Systemic illness not appropriate for chemotherapy
- Radiotherapy within 2 weeks before the study entry
- Allergy to drugs used in the trial
Key Trial Info
Start Date :
May 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00313872
Start Date
May 1 2003
End Date
January 1 2010
Last Update
January 12 2012
Active Locations (1)
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1
Samsung Medical Center
Seoul, South Korea