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

Samsung Medical Center

Status and phase: Completed; Phase 3

Conditions: Advanced Gastric Cancer

Treatments: Other: Best supportive care; Drug: Chemotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00821990

2008-08-055

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: Under 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Chemotherapy

Active Comparator group

Description:

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).

Treatment:

Other: Best supportive care

Drug: Chemotherapy

Supportive care

Active Comparator group

Description:

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).

Treatment:

Other: Best supportive care