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

Phase 3

Completed

• Conditions: Advanced Gastric Cancer
• Interventions: Drug: Chemotherapy; Other: Best supportive care

• Registration Number: NCT00821990
• Lead Sponsor: Samsung Medical Center

Brief 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.

Detailed Description

Fluoropyrimidine and/or platinum-based chemotherapy is now regarded as a standard first-line treatment in AGC patients because it has shown superiority in terms of response rate and time to disease progression compared with 5-FU monotherapy and other combinations in phase III trials. Despite the lack of evidence for benefit associated with administering salvage chemotherapy, it is a common practice to offer further chemotherapy for AGC patients after first-line failure. For patients who failed after fluoropyrimidine and platinum, taxanes (paclitaxel or docetaxel) and irinotecan have been evaluated extensively in the second-line setting.

Currently, there is no evidence that SLC in patients with AGC will result in substantial prolongation of survival and there is potential for toxicity from the treatment.

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2008-12-29
• Study First Submitted QC: 2009-01-13
• Study First Posted: 2009-01-14
• Primary Completion: 2010-09
• Study Completion: 2011-06
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-18
• Last Update Posted: 2012-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chemotherapy	Chemotherapy	Eligible patients will be first offered randomization. If willing to participate RCT, the patient will be randomized to chemotherapy or best supportive care. If patients refuse to participate in RCT, but nevertheless agree to receive treatment of their preferences, they are offered their treatment of choice (chemotherapy or supportive care).
Chemotherapy	Best supportive care	Eligible patients will be first offered randomization. If willing to participate RCT, the patient will be randomized to chemotherapy or best supportive care. If patients refuse to participate in RCT, but nevertheless agree to receive treatment of their preferences, they are offered their treatment of choice (chemotherapy or supportive care).
Supportive care	Best supportive care	Eligible patients will be first offered randomization. If willing to participate RCT, the patient will be randomized to chemotherapy or best supportive care. If patients refuse to participate in RCT, but nevertheless agree to receive treatment of their preferences, they are offered their treatment of choice (chemotherapy or supportive care).

Primary Outcome Measures

Name	Time	Method
Survival	1 year after last patient entered

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of