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Spots Global Cancer Trial Database for Second-line Therapy Versus Supportive Care for Pretreated Advanced Gastric Cancer

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Trial Identification

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

Official Title: A Patient Preference Randomized Phase III Clinical Trial of Second-line Chemotherapy (SLC) in Advanced Gastric Cancer (AGC) Patients Pretreated With Both Fluoropyrimidines and Platinum

Study ID: NCT00821990

Study Description

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.

Eligibility

Minimum Age:

Eligible Ages: CHILD, ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Samsung Medical Center, Seoul, , Korea, Republic of

Contact Details

Name: Se Hoon Park, MD

Affiliation: Samsung Medical Center, Seoul, Korea

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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