Overview

Second-line Therapy Versus Supportive Care for Pretreated Advanced Gastric Cancer

Status:
Completed
Trial end date:
2011-06-01
Target enrollment:
0
Participant gender:
All
Summary
Because well-designed, randomized, controlled clinical trials are lacking in patients with advanced gastric cancer (AGC), and because randomly allocating patients to treatments that do not accord with their preferences may influence trial validity, the investigators employed a patient preference randomized trial design to compare the efficacy of second-line chemotherapy and best supportive care.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Samsung Medical Center
Criteria
Inclusion Criteria:

- aged 75 year or younger

- advanced gastric cancer

- ECOG performance status 0 or 1

- previous failure after chemotherapy with fluoropyrimidine and platinum

- adequate major organ functions

Exclusion Criteria:

- severe concurrent illness and/or active infection

- previously treated with taxanes and irinotecan

- active CNS metastases

- pregnant or lactating women

- who have not recovered from prior treatments