Advanced Gastric Cancer
Conditions
Keywords
Failed after previous chemotherapy
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.
Interventions
DRUGChemotherapy
The administration of chemotherapy regimen (docetaxel or irinotecan) will be determined at the discretion of investigator, and depends on the patient's previous chemotherapy.
OTHERBest supportive care
It includes nutritional support, analgesics, antibiotics, antiemetics, transfusions, or any other symptomatic therapy (with the exception of cytotoxic chemotherapy) and/or assistance of a psychological support. Localized radiotherapy to alleviate symptoms such as pain is allowed provided that the total dose delivered is in a palliative range.
Sponsors
Samsung Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Survival | 1 year after last patient entered |
Countries
South Korea
Outcome results
None listed