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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


Phase 3
N/A
75 Years
Not Enrolling
Both
Advanced Gastric Cancer

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Survival

Outcome Time Frame:

1 year after last patient entered

Safety Issue:

No

Principal Investigator

Se Hoon Park, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Samsung Medical Center, Seoul, Korea

Authority:

Korea: Food and Drug Administration

Study ID:

2008-08-055

NCT ID:

NCT00821990

Start Date:

September 2008

Completion Date:

June 2011

Related Keywords:

  • Advanced Gastric Cancer
  • Failed after previous chemotherapy
  • Stomach Neoplasms

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