Phase III Trial of DP Followed by FOLFIRI or the Reverse Sequence in Unresectable Gastric Cancer

• Status: Completed
• Trial end date: 2010-01-01
• Target enrollment: 0
• Participant gender: All

Summary

To assess the optimal sequence of the palliative chemotherapy regimen (DP --> FOLFIRI vs FOLFIRI --> DP) in metastatic gastric cancer patients.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Samsung Medical Center
• Treatments: Cisplatin; Docetaxel; Irinotecan

Criteria

Inclusion Criteria:

1. Histologically confirmed metastatic adenocarcinoma of the stomach

2. Age ≥ 18

3. Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2

4. Life expectancy of at least 3 months

5. Adequate renal, liver, bone marrow functions

6. Adjuvant chemotherapy more than 12 months from the date of study entry

7. Written informed consent

Exclusion Criteria:

1. Active infection requiring antibiotics

2. Pregnant, lactating women

3. Brain metastasis

4. Systemic illness not appropriate for chemotherapy

5. Radiotherapy within 2 weeks before the study entry

6. Allergy to drugs used in the trial